AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

June 25, 2024

AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of KAI™ 12L AI technology and the Kardia™ 12L ECG System.

This is the world’s first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

“Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet,” said Priya Abani, CEO of AliveCor. “Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care.”

Kardia 12L ECG System is an innovative solution that requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience.

“The AI innovations in the Kardia 12L ECG System offer healthcare providers a clinically-validated handheld 12-lead ECG system and expands this critical technology into more resource-limited settings,” said Dr. Stavros Stavrakis, MD, PhD, Professor of Medicine, Division of Cardiology at the University of Oklahoma Health Sciences Center. “By streamlining the process of recording a 12-lead ECG, Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice.”

Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.

Dr Fred Cohen: Higher Temperatures Trigger Migraines According to New Study

June 25, 2024

It is only the first full week of summer, and a record-breaking heatwave is already sending temperatures soaring to dangerously high levels in the Northeast and Midwest, with much of the U.S. suffering through sweltering humidity. One medical researcher is cautioning people to watch for headache and migraine attacks as a result. Specifically, Dr Fred Cohen, Assistant Professor of Medicine and Neurology at the Icahn School of Medicine at Mount Sinai in New York, recently co-authored a new headache study that he presented at the American Headache Society’s 66th Annual Scientific Meeting in San Diego, CA, which demonstrates a relationship between weather variables and headache attacks in individuals with migraines.

The Annual Scientific Meeting is designed for physicians, psychologists, scientists, researchers, physician assistants, nurse practitioners, and other health professionals involved in the care of patients with head, neck, and orofacial pain.

“Many triggers are associated with headaches and migraines, but weather changes are among the most commonly reported; however, data and metrics on these weather changes have rarely been published until now,” said Dr. Cohen. “Our groundbreaking study finds that increased temperature, humidity, and barometric pressure typically intensifies headache attacks in the 40 million Americans who suffer from migraines.”

In the study, researchers examined 71,030 daily diary records from 660 migraine patients and correlated them with regional weather data. They discovered that for each 10-degree Fahrenheit rise in daily temperature, there was a 6% increase in headache occurrences.

Dr Fred Cohen notes that there is hope on the horizon as the study also indicates that patients who were treated with Fremanezumab (Ajovy®), a calcitonin gene-related peptide (CGRP) monoclonal antibody treatment approved by the FDA for migraine prevention, improved these weather-related headaches.

“This study is the first to suggest that migraine-specific therapies that block CGRP may treat weather associated headaches,” adds Dr. Cohen. “It’s quite remarkable that, despite the diverse weather patterns nationwide, we were able to identify such a significant influence. It also raises concerns about greater weather variability and more frequent severe weather events and their relationship with migraines, especially as climate change progresses.”

Another keynote theme of the conference was the use of artificial intelligence (AI) in headache diagnosis, management, and detecting migraine comorbidities. Dr. Cohen gave a lecture on the use of large language models (LLMs), such as ChatGPT and CoPilot, in clinical practice and their potential to improve provider efficiency. Other emerging topics included new acute treatments for migraine, such as vaporized cannabis and novel targets like transient receptor potential melastatin 3 (TRPM3) and pituitary adenylate cyclase-activating polypeptide (PACAP).

Qure.ai Reports Strategic Investment by Merck Global Health Innovation Fund to Boost Innovation of Healthcare AI

June 25, 2024

Merck Global Health Innovation Fund has made a strategic investment into Qure.ai as part of its Series D round. This funding will go towards investing into foundation models for artificial intelligence (AI) in imaging and expanding geographical reach of Qure.ai’s AI-powered imaging solutions into the US market.

Globally Qure.ai has delivered AI-augmented detection for Tuberculosis (TB), Lung Cancer and Stroke at over 2700 imaging sites, across more than 90 countries. It has clearance from the United States Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) for its AI-powered Chest X-ray lung nodule detection solution (qXR-LN); breakthrough device designation for TB solution (qSpot-TB); an AI-enabled head CT tool to expedite the detection, triage and quantification of traumatic brain injuries and stroke (qER-Suite); plus multiple other plain film X-ray emergency room findings.

With ever growing patient populations and burden of disease on health systems continuing to exert pressure, healthcare AI presents a huge opportunity to power early identification and management.

“Healthcare AI provides the opportunity to review people faster as we have shown in patients with TB in low-and middle-income countries, as well as lung cancer and emergency triage in the UK’s National Health Service,” said Prashant Warier, Co-founder and CEO of Qure.ai. “This strategic investment in Qure.ai from the Merck Global Health Innovation Fund will enable us to expedite our work in foundation models and expand the reach of our AI both geographically and demographically.”

“Initial real-world studies and recent FDA clearances have provided compelling evidence for the potential of Qure.ai’s medical imaging AI innovations,” said David M. Rubin, Managing Director, Merck Global Health Innovation Fund LLC. “AI has the potential to power the early diagnosis of lung cancer, TB or Stroke giving the best chance of survival outcomes and improving quality of life for patients.”

Merck had previously invested in Qure.ai, as part of its impact investing portfolio led by the Merck Office of Social Business Innovation.

Injuries in Truck Accidents: Unique Medical and Legal Aspects in Florida

June 25, 2024

Truck accidents can result in serious mental and physical injuries, largely due to the size and power of commercial trucks involved. These accidents give rise to various unique medical and legal matters that demand careful attention from victims and legal experts. Throughout this guide, we will provide more information on the distinctive aspects of injuries sustained in truck accidents within Florida and the complex medical details and legal intricacies that need to be considered.

It’s essential to recognize that recovering from such accidents involves more than just physical healing; it requires navigating a detailed landscape of medical treatment and legal procedures.

Medical Complexities in Truck Accident Injuries

Regarding truck accident injuries, the sheer force of impact can result in severe medical conditions that demand specialized care. Medical professionals and first responders must be well-versed in treating these complex injuries promptly and efficiently.

For more information about seeing medical assistance as soon as possible following an accident, you can contact a Gainesville truck accident attorney now for assistance.

Until then, here are some unique medical injuries to consider:

Traumatic Brain Injuries (TBIs)

Truck accidents can subject occupants of smaller vehicles to violent jolts and impacts, often leading to traumatic brain injuries. TBIs can vary widely in severity, from concussions to more severe brain damage. Victims of truck accidents will likely require extensive medical attention, rehabilitation, and ongoing monitoring to assess the long-term effects of the injury.

Spinal Cord Injuries

The sheer impact of a truck collision alone could cause spinal cord injuries, leading to paralysis or severe motor impairments. These injuries often require immediate medical intervention, surgeries, and a comprehensive rehabilitation plan to regain functionality and improve the victim’s quality of life.

Internal Injuries

In a truck crash, the impact force can cause internal injuries that might not be immediately evident. These injuries could include internal bleeding, organ damage, or fractures to the ribs or other bones. Medical professionals must conduct thorough examinations to detect and treat these hidden injuries effectively.

Crush Injuries

Truck accidents can lead to crush injuries, where a part of the victim’s body gets trapped between two objects or within the vehicle. These injuries can result in broken bones, soft tissue damage, and even amputations, requiring extensive medical interventions and surgeries.

Psychological and Emotional Impact

The aftermath of a truck accident can also take a toll on victims’ mental health. PTSD, anxiety, and depression are common psychological responses to traumatic events. Addressing the mental health and emotional well-being of truck accident victims is crucial for their overall recovery.

Legal Considerations in Truck Accident Injuries

Truck accident cases involve unique legal considerations that differentiate them from typical car accident cases. The involvement of commercial entities, federal regulations, and complex liability determinations can make these cases particularly intricate.

The following are some legal aspects to be aware of:

Commercial Vehicle Regulations

Truck accidents involve vehicles subject to federal regulations that don’t apply to smaller vehicles. These regulations govern driver hours of service, maintenance requirements, and weight limits. Violations of these regulations can impact liability and contribute to the cause of the accident.

Multiple Parties and Liability

Truck accidents can involve multiple parties beyond just the drivers, such as trucking companies, cargo loaders, and maintenance crews. Determining liability in these cases may require a thorough investigation to identify all contributing factors.

Complex Insurance Coverage

The insurance coverage involved in truck accidents can be more intricate due to the commercial nature of the vehicles. Trucking companies often have higher insurance limits, and multiple insurance policies might come into play, such as commercial liability insurance and cargo insurance.

Evidence Collection and Preservation

Given the complexity of truck accident cases, collecting and preserving evidence is crucial for building a strong case. This includes obtaining the truck’s black box data, driver logs, maintenance records, and available surveillance footage. The timeliness of evidence collection can significantly impact legal proceedings.

Expert Witnesses

Expert witnesses play a vital role in truck accident cases, offering their specialized knowledge to help establish liability and causation. These experts might include accident reconstructionists, trucking industry professionals, and medical specialists who can testify about the extent of the injuries.

Deal With Your Truck Accident Injuries In the Best Way Possible

Truck accidents bring many unique medical and legal considerations that demand careful attention and expertise. From the complex medical treatments required to address severe injuries to the intricate legal aspects involving commercial regulations and liability determinations, the aftermath of a truck accident is a complex terrain to navigate.

By recognizing the distinct challenges posed by truck accident cases and collaborating with skilled legal advocates, victims can pursue the reimbursement they deserve and begin healing and recovery.

The LM Scaffold System™ | An Evolution in Tracheobronchomalacia Treatment | By Richard Lazzaro, MD, Co-Founder of Lazzaro Medical and Southern Region Chief of Thoracic Surgery for RWJBarnabas Health

June 25, 2024

Tracheobronchomalacia: An Underrecognized Challenge

Tracheobronchomalacia (TBM) is characterized by the weakening of the cartilage and then collapse of the airway walls, leading to severe respiratory difficulties. Despite its debilitating effects, and its prevalence TBM often goes underdiagnosed due to overlapping symptoms with other respiratory disorders like Asthma and COPD. Patients experience a range of symptoms from seal-like coughing and frequent respiratory infections to life-threatening breathing struggles. Traditional treatments involve invasive surgical procedures that come with high risks and prolonged recovery times.

The Crucial Need for Advanced Treatment Options

TBM affects an estimated 8 million people in the US alone. Current treatment options for TBM are limited and often fail to provide long-term relief or improved quality of life for patients. The patented LM Scaffold System™ aims to address this critical need by offering a safer treatment option. This evolutionary device provides structural support to the weakened airway walls and is designed to help patients and provide improvement just days after the surgery.

The LM Scaffold System™: A Product Evolution

The LM Scaffold System™ represents an advancement in TBM treatment. This innovative device is designed to provide structural support to the trachea and bronchi, restoring their normal function much more efficiently than the current product used today for TBM repair via a tracheobronchoplasty. It can be implanted either through an open tracheobronchoplasty (TBP) or robotically. When combined with minimally invasive, robotically-assisted implantation process, The LM Scaffold System™ aims to create repeatable surgical intervention while minimizing patient recovery time. The second FDA pre-submission meeting is scheduled for early July. It is anticipated that the LM Scaffold System™ will be cleared next year.

Why the LM Scaffold System™ is Different

The LM Scaffold System™ is designed to impact patients with TBM in several ways:

Minimally Invasive Approach: Traditional TBM treatments involve open surgery, which is highly invasive and comes with significant risks and recovery times. The LM Scaffold System™, on the other hand, can be implanted using a minimally invasive, robotically-assisted technique, which is designed to reduce surgical trauma, lower the risk of complications, and shorten recovery times.
Repeatability and Standardization: The robotically-assisted Minimally Invasive Tracheal Repair (MITR™) technique employed with the LM Scaffold System™ is designed to standardize surgical repair. This standardization can help ensure that more surgeons, regardless of experience level, can achieve similar results. The LM Scaffold System™ helps “level the playing field,” and can enable less experienced surgeons to perform the surgery similarly to their more seasoned counterparts.
Specific Design: Unlike standard mesh used for airway repairs, the LM Scaffold System™ features two interlocking pieces that connect like a zip tie. It is designed to enable a secure and stable reinforcement of the airway, and a clear view of the tracheal anatomy allowing robotic surgeons to help reinforce the structural integrity and function of the trachea and bronchi. It is estimated that an FDA-clearance of a product for the remediation of TBM in the form of the LM Scaffold System™ may reduce time in the operating room by approximately 50%.

A Dual Approach to TBM Treatment

The LM Scaffold System™ and the minimally invasive tracheal repair (MITR™) procedure are not separate solutions but rather help become complementary parts of a unified approach. Early in our research, we discovered that many patients with progressive symptoms were not responding to treatments because their airway, not their lungs, was the root cause of their issues. This realization led to a dual approach: the development of the LM Scaffold System™ and the refinement of the minimally invasive surgical repair technique (MITR™).

The Benefits of the LM Scaffold System™

The LM Scaffold System™ is designed to help:

Improve Breathing: By stabilizing the airway, the LM Scaffold System™ is anticipated to help restore the natural anatomy and function of the trachea and bronchi. This can help patients experience improvements in their ability to inhale and exhale, reducing shortness of breath and improving overall respiratory function.
Lessen Debilitating Symptoms: The design of the LM Scaffold System™ can allow patients to breathe easier and reduce symptoms like chronic coughing and recurrent infections. This improvement in respiratory function can be life-changing, allowing patients to engage in daily activities and social interactions without the debilitating symptoms of TBM.
Reduce Recovery Times: The minimally invasive, robotically-assisted implantation process can enable patients to experience less surgical trauma, leading to faster recovery times and a quicker return to normal activities.

The Technology Behind the Innovation

The core of Lazzaro Medical’s innovation lies in its unique approach to the structural support of the trachea and bronchi. Utilizing advanced robotics and state-of-the-art imaging technology, the company has developed a minimally invasive procedure that can reduce the risks associated with traditional surgery. This new technique not only aims to be safer but much more efficient, reducing surgery time by as much as 50% and in doing so can create faster recovery times and better long-term outcomes for patients.

Collaboration + Grant = Future Prospects

The development of this innovative treatment is the result of collaboration between Lazzaro Medical and leading medical researchers and institutions. The company has recently been awarded a $2.4 million Small Business Innovation Research (SBIR) Direct to Phase II grant from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The grant will further enhance these collaborative efforts, supporting ongoing research and development efforts, verification and validation, preclinical work, and regulatory activities.

The partnership Lazzaro Medical has with top-tier medical researchers and institutions, including Mayo Clinic and Northwell Health has been crucial in advancing this technology. The grant will enable the acceleration of research and move the medical world closer to providing a viable treatment option for TBM patients worldwide.

Impact on the Medical Community

The implications of Lazzaro Medical’s innovation extend beyond TBM. The development of a minimally invasive, robotically-assisted platform for airway treatment could pave the way for similar advancements in other areas of respiratory medicine. This breakthrough has the potential to set a new standard in the treatment of airway conditions, offering a safer, more effective alternative to traditional surgical methods.

Patient-Centric Care

At the heart of Lazzaro Medical’s mission is a commitment to patient-centric care. By focusing on minimally invasive techniques, the company aims to improve the patient experience, reducing pain, recovery times, and the overall impact of treatment on patients’ quality of life. This approach will not only benefit patients physically but can also contribute to better mental and emotional well-being by minimizing the stress and anxiety associated with invasive medical procedures and long recovery.

The Road Ahead

With strategic funding from institutions such as Northwell Health, Mayo Clinic and a recently awarded Direct to Phase II SBIR grant from the National Institutes of Health (NIH), Lazzaro Medical is poised to make strides in its mission to improve patient care for those suffering from Tracheobronchomalacia (TBM) by advancing the development of its robotically assisted, Minimally Invasive Tracheal Repair (MITR™) procedure, using its patented LM Scaffold System™. The goal is to bring this innovative treatment to TBM patients.

The support from the NIH is a crucial step in a critical journey. It enables Lazzaro Medical to continue its focus to bring innovative diagnostics and treatment to those who need it most and highlights the importance of eradicating this degenerative disease. The LM Scaffold System™ is the first step in a broader platform to enhance diagnosis and treatment of patients with TBM. Improved diagnostics and standardization of surgical repair can help facilitate adoption and fuel growth. The LM Diagnostic Scope™ which is being designed for use “in office” to shorten the time and effort to correctly and quickly diagnose TBM and the LM DuLET™, a more efficient patent-pending non-occlusive double lumen endotracheal tube that is designed to further simplify the MITR™ procedure and other surgeries.

LM Scaffold System™, LM DL Tube™ and LM Scope™ are not cleared or approved products by regulatory bodies in the US or internationally and are pending FDA submission.

Editor’s Comments: Richard Lazzaro, MD is a world-renowned thoracic surgeon with over 35 years of specialized expertise in minimally invasive and robotic surgery. With a deep commitment to advancing medical technology and improving patient outcomes, Dr. Lazzaro leads the development of innovative treatments for tracheobronchomalacia and other respiratory conditions. His visionary approach and dedication to patient-centric care have positioned Dr. Lazzaro at the forefront of medical innovation.

For more information about Lazzaro Medical and their innovative treatments, visit Lazzaro Medical’s website.

Ronil Patel Appointed Chief Business Officer at RevOpsis Therapeutics

June 24, 2024

In his new role, Ronil Patel will be responsible for RevOpsis’ global strategy and business development.

Patel brings over 15 years of experience in drug development, with a strong track record in early-stage asset management, strategic R&D decisions, and designing fast-to-market strategies. He excels in realizing commercial value, addressing unmet needs, and facilitating strategic transactions and funding for biotech companies.

“We are thrilled to welcome Ronil Patel to the RevOpsis team,” said Ram Bhandari, interim CEO of RevOpsis. “His extensive experience in the healthcare industry, particularly in the ophthalmic sector, and his strategic vision will be invaluable as we advance our lead asset RO-104 and other product candidates. Ronil’s leadership will be instrumental in driving our corporate strategy, business development, and operational excellence.”

Ronil Patel currently serves as a strategic advisor to Collage Venture Partners and was previously the Chief Business Officer at Ocuphire Pharma, a publicly traded ophthalmology biotechnology company. Prior to Ocuphire, Patel led business development for Point Guard Partners and Oculos Clinical Research (now iuvo Bioscience). Patel has been instrumental in biotech research and development and global business expansion. He has also contributed to teams that have secured approximately $100 million in funding and finalized licensing and exit deals valued at over $500 million.

“The science behind RevOpsis is what attracted me to the company,” said Patel. “The RevMod platform, particularly the lead asset RO-104, addresses a significant unmet need in the retina market. The management and Board’s vision for the company, along with their passion for patient care, were key drivers in my decision to join. My primary goal is to prepare the company for near-term growth as our product candidates mature through the drug development process, and to increase business development efforts with pharma partners and investors to share and amplify RevOpsis’ story.”

Patel highlighted some of the current challenges and opportunities in the ophthalmic industry: “Funding is one of the biggest challenges, and RevOpsis is one of the few private companies that has managed to secure funding to progress RO-104 through important milestones. Sustainable vision gains and treatment durability continue to be significant unmet needs in the treatment of neovascular AMD; as innovators in the development of multispecific biologics for ocular use, RevOpsis has the potential to transform the treatment of retinal vascular diseases”.

Looking ahead, Patel envisions RevOpsis as a global leader in multispecific antibodies, beginning with retinal diseases. He aims to build upon existing processes and relationships, bringing in resources and vendor partnerships to support the company’s accelerated path to human clinical trials.

“My vision for RevOpsis is to be a leader in multispecific antibodies by maximizing the ‘plug-and-play’ capabilities of the RevMod platform,” he added. “We have a talented team of scientists that can progress product candidates, and we plan to enlist partners with the experience, know-how, and resources to bring these candidates across the finish line.”

About RO-104
Leveraging the proprietary RevMod platform, RO-104 is RevOpsis’ current lead candidate. Engineered as a first-in-class fully human modular tri-specific biologic designed to address all three clinically validated dominant angiogenic pathways (VEGF-A, VEGF-C, Ang-2) implicated in retinal vascular disease progression, including neovascular age-related macular degeneration (nAMD). RO-104 represents a significant innovative advancement in the treatment landscape for retinal vascular diseases. Backed by a significant body of preclinical evidence demonstrating intended efficacy and safety in established animal models, RO-104 heralds a transformative approach positioned to redefine the current standard of care for patients with nAMD.

About RevMod Platform
The proprietary RevMod Platform employs a modular ‘plug-and-play’ approach to streamline and expedite the efficient discovery and development of multispecific biologics targeting a wide spectrum of chronic, prevalent, large diseases, that are the leading causes of death and disability worldwide. Our proprietary platform boasts a vast library of nearly 30 billion fully human antibody components in a structured phage display system, facilitating rapid identification and assembly of multispecific product candidates. With seamless compatibility, the RevMod platform enables swift and efficient design of multispecific biologics to address unmet needs in major therapeutic areas including ophthalmology, oncology, and immune-mediated diseases.

SOPHiA GENETICS Launches New Residual Acute Myeloid (RAM) Application

June 24, 2024

SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced its new Residual Acute Myeloid (RAM) Application. The new offering expands the company’s comprehensive oncology portfolio to support measurable residual disease (MRD) capabilities and will be available to customers worldwide this summer.

Acute Myeloid Leukemia (AML) represents about one percent of all cancers worldwide, yet is one of the most common forms of leukemia in adults1. Over 50 percent of AML patients relapse within 3 years after achieving complete remission2, therefore post-treatment monitoring is imperative for AML patients, particularly within the first two years, to help quickly detect any signs of relapse3. MRD solutions can help inform post-remission therapy and identify early relapse, and serve as a primary endpoint in clinical trials, helping researchers detect even the smallest trace of cancer and support better patient outcomes.

AML unfortunately still remains an area of high unmet medical need today, with associated suboptimal patient outcomes. MRD measurement and monitoring has a critical role to play, for example by enabling research into the most optimal sequencing of therapies,” said Philippe Menu, M.D., PhD., Chief Medical Officer and Chief Product Officer, SOPHiA GENETICS. “We are proud to contribute to the fight against AML through our SOPHiA DDM™ RAM Solution. In particular we feel that the capability to seamlessly track longitudinally the evolution of individual mutations over time through a dedicated add-on module of our SOPHiA DDM™ Platform has the potential to be a game-changer for clinical researchers.”

Next-generation sequencing (NGS)-based MRD testing is among the most advanced in cancer screening and monitoring, and can be found only with highly sensitive methods. The SOPHiA DDM™ RAM Solution provides users with the confidence that MRD will detect even one cancer cell among 10,000 cells. This application will allow users to stay ahead of disease response with the analytical capabilities of the SOPHiA DDM™ Platform, enabling sensitive variant detection down to 0.01% VAF and covering guideline-recommended genes to deliver robust insights for residual acute myeloid.

Customers using the SOPHiA DDM™ RAM Solution will have access to longitudinal variant monitoring, allowing them to visualize the mutational landscape for each patient and its evolution over time. The solution also provides users with the most up-to-date databases and customizable reporting features to generate graphical representations and comprehensive MRD reports.

Additionally, the SOPHiA DDM™ RAM Solution will continually hone its machine learning algorithms to provide the most accurate MRD results in just four days.

Representatives from SOPHiA GENETICS are available at AMP (Association for Molecular Pathology) Europe June 24-27 to discuss AML monitoring with this new application.

Endotronix Receives FDA Premarket Approval of the Cordella PA Sensor System for the Treatment of Heart Failure

June 24, 2024

Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The Cordella platform is the first and only PA pressure-guided platform to offer comprehensive patient management using daily PA pressure and vital signs from home to guide therapeutic management and improve patient outcomes.

“This approval is very exciting and has the potential to transform care for HF patients. Endotronix’s solution provides a more complete clinical picture of the patient, so providers are able to make informed remote care decisions between office visits,” stated Dr. Liviu Klein, Section Chief of Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension, and Heart Transplant at the University of California San Francisco and national principal investigator of the PROACTIVE-HF trial. “PROACTIVE-HF demonstrated that with Cordella clinicians achieved more optimal and timely dosing of key HF medications, significantly improving outcomes. In addition, the easy-to-use platform engages patients to drive consistent daily habits and self-awareness of trends to support sustainable lifestyle changes.”

Cordella is a proactive HF management platform that delivers daily PA pressure and other vital data via an implantable sensor and user-friendly, non-invasive health tools, respectively, to a managing HF clinician for remote patient care. This information guides clinical decision-making and medication dosing while enhancing the adoption of guideline-directed medical therapy (GDMT) to reduce congestion and improve outcomes. Regulatory approval was based on the PROACTIVE-HF trial, which demonstrated a markedly low 0.159 rate of heart failure hospitalization and all-cause mortality at 6 months.

In addition, Cordella enables:

Seated PA pressure measurements, preferred by most patients, with a handheld reader.
Patient visibility into key health trends to support healthy lifestyle changes.
Secure messaging on a tablet between the clinical team, patient, and caregiver to support remote care.
Reimbursement for implantation and ongoing management through existing reimbursement pathways.

“At Endotronix, we firmly believe that innovation can drive patient care excellence in the home and ultimately change outcomes for patients with heart failure, one of the largest cost categories in healthcare. The FDA’s approval validates this foundational belief and is a major milestone for our company and the field of HF management,” commented Harry Rowland, CEO and co-founder of Endotronix. “With this approval, we will deliver proactive, comprehensive care that extends optimal HF therapeutic management to more patients, keeping them out of the hospital and living more fulfilling lives.”

Endotronix will launch Cordella in the U.S. later this year. The company also shared that they have submitted a dossier for CE Mark review and expect a decision on European market access in 2025.

Venous Thromboembolism Treatment Market to be Worth $4.40 Billion by 2030

June 24, 2024

According to a new market research report titled ‘Venous Thromboembolism Treatment Market by Device (Thrombectomy, Inferior Vena Cava Filter [Retrievable, Permanent], Stockings, Compression Pump) Application (DVT, Pulmonary Embolism) End User (Hospital, Ambulatory Care Center) – Global Forecast to 2030,’ published by Meticulous Research®, the venous thromboembolism treatment market is projected to reach $4.40 billion by 2030, at a CAGR of 7.2% from 2023 to 2030.

Venous thromboembolism occurs when a blood clot is formed in the veins of the arms or legs and moves through the bloodstream. It obstructs blood and oxygen flow, causing tissue and organ damage. Deep vein thrombosis and pulmonary embolism are both signs and symptoms of venous thromboembolism. These symptoms and the condition itself can be treated using certain devices such as thrombectomy devices, inferior vena cava filters, compression pumps, stockings, and other devices.

The high prevalence of venous thromboembolism, rising incidence of cancer, growing prevalence of secondary risk factors such as diabetes and obesity, increase in orthopedic surgical procedures, and the rising demand for minimally invasive treatment procedures are the factors driving the growth of the venous thromboembolism treatment market. Furthermore, the growing accessibility and affordability of treatment options, advancements in VTE diagnosis and treatment methods, and the market expansion in emerging economies are expected to create market growth opportunities.

However, instances of product failure and product recalls may restrain the market’s growth. Additionally, lack of awareness about venous thromboembolism and increasing awareness of probable side effects of compression garments are major challenges for market growth.

The report also includes an extensive assessment of the key growth strategies adopted by leading market participants over the past three to four years. The global venous thromboembolism treatment market has witnessed several product launches, approvals, and acquisitions in the last couple of years.

Get a Glimpse Inside: Request Sample Pages- https://www.meticulousresearch.com/request-sample-report/cp_id=5745

Some of the key players operating in the global venous thromboembolism treatment market are ALN Implants chirurgicaux (France), AngioDynamics, Inc. (U.S.), Argon Medical Devices, Inc. (U.S.), ArjoHuntleigh AB (Sweden), Boston Scientific Corporation (U.S.), Cardinal Health, Inc. (U.S.), Cook Group Incorporated (U.S.), Koninklijke Philips N.V. (Netherlands), DS MAREF Co., LTD (South Korea), Enovis Corporation (U.S.), LifeTech Scientific Corporation (China), Medtronic plc (Ireland), and Stryker Corporation (U.S.).

High Prevalence of Venous Thromboembolism to Drive Market Growth

Vascular diseases impact the blood flow in veins and arteries. Venous thromboembolism involves the formation of a blood clot in a vein, which can potentially block the blood flow and pose a life-threatening risk. When these clots occur in deep veins, such as those in the lower legs, thighs, arms, or pelvis, the condition is referred to as deep vein thrombosis (DVT). In some instances, a clot can detach, travel through the bloodstream to the lungs, and result in pulmonary embolism (PE).

Venous thromboembolism is a very common condition with a high prevalence globally. There is limited data on the exact number of people affected by venous thromboembolism. However, according to the American Heart Association report (2021), every year, around 1,220,000 people in the U.S. are affected by the disease. According to the World Health Organization (WHO), VTE is a common and potentially fatal condition, with an estimated annual incidence of 1-2 cases per 1,000 people. The incidence of VTE increases with age, with the highest rates observed in individuals over the age of 60.

Have Specific Research Needs? Request a Customized Report- https://www.meticulousresearch.com/request-customization/cp_id=5745

Furthermore, according to a 2022 study published in Nature Reviews Cardiology, the incidence of venous thromboembolism in the U.S. and Europe was estimated at 1-2 cases per 1,000 persons per year, while in Australia, it was estimated to be 0.8 cases per 1,000 per year.

Venous thromboembolism can result from an imbalance of blood-clotting proteins, inherited factors, physical inactivity injuries, or infections, among other causes. Additionally, venous thromboembolism is more prevalent in the elderly population. The high prevalence of venous thromboembolism is boosting the demand for various VTE prevention products, driving the growth of this market.

The global venous thromboembolism treatment market is segmented by device (thrombectomy devices, inferior vena cava filters {retrievable filters and permanent filters}, stockings, compression pumps, and other devices & accessories), application (deep vein thrombosis and pulmonary embolism), end user (hospitals, ambulatory care centers, and other end users), and geography. The study also evaluates industry competitors and analyzes the market at the global and regional levels.

Based on device, in 2023, the thrombectomy devices segment is expected to account for the largest share of the venous thromboembolism treatment market. The large market share of this segment is attributed to the increasing prevalence of cardiovascular diseases, growing preference for minimally invasive procedures, and launches of new thrombectomy devices. Thrombectomy devices are employed in the treatment of venous thromboembolism (VTE), acute stroke, pulmonary embolism (PE), and deep vein thrombosis (DVT). Venous thrombectomy is performed in patients with severe cases of DVT that may lead to PE. According to various research studies, approximately 13-31% of critically ill patients develop DVT, which requires interventional procedures like thrombectomy.

Based on application, in 2023, the deep vein thrombosis segment is expected to account for the large market share of the venous thromboembolism treatment market. The large market share of this segment is attributed to the increasing prevalence of obesity, a growing geriatric population, rising cases of deep vein thrombosis due to lifestyle-related diseases, excessive alcohol consumption, and heightened awareness of DVT. The aging population is susceptible to various medical conditions, including cardiovascular diseases, obesity, cancer, and diabetes, all of which elevate the risk of DVT. Various factors, such as a family history of blood clots, obesity, hormone replacement therapy, injury, surgery, lack of movement, smoking, and heart failure, can contribute to DVT. According to the United Nations, in 2022, there were 771 million people aged 65 years or over globally, a number expected to reach 994 million by 2030 and 1.6 billion by 2050. Additionally, the Centers for Disease Control and Prevention (CDC) reported in June 2023 that approximately 900,000 people in the U.S. were affected by deep vein thrombosis in 2022. Hence, the high prevalence of DVT drives the demand for venous thromboembolism treatment and prevention devices.

Based on end user, in 2023, the hospitals segment is expected to account for the large share of the venous thromboembolism treatment market. The large market share is attributed to the increasing prevalence of venous thromboembolism, the rising number of hospitals and clinics, the presence of highly skilled professionals, and the high purchasing power of hospitals. The easy accessibility to hospitals, coupled with a large patient population seeking comprehensive healthcare services, including diagnosis, treatment, and surgeries at a single location, also contributes to the significant market share of this segment. Venous thromboembolism requires a sequential work-up and advanced technologies for treatment. Many hospitals are integrating sophisticated technologies such as compression pumps and thrombectomy devices to streamline the treatment process for patients.

Geographically, in 2023, North America is expected to account for the largest share of the venous thromboembolism treatment market, followed by Europe. However, Asia-Pacific is slated to register the highest CAGR in the venous thromboembolism treatment market during the forecast period. The growth of this regional market can be attributed to factors such as the growing prevalence of chronic diseases, the increasing number of people living sedentary infrastructure, and rising awareness regarding venous thromboembolism.