Accuray Receives CE Mark for a New Helical Radiation Delivery System, Accuray Helix

August 27, 2024

Accuray Incorporated (NASDAQ: ARAY) announced today the company has received CE Mark for Accuray Helix™, a CT-guided helical radiotherapy system designed to provide high-performance and high-throughput.

The new system is intended for emerging markets where access to advanced cancer care, including radiotherapy treatments, is typically obtainable only within urban areas and where the availability of linear accelerators per million population is well below the World Health Organization recommended guidelines. Accuray Helix offers a solution for clinical teams that require short treatment times and cost effectiveness to establish a care path for patients in non-urban communities who previously had limited options.

Radiotherapy is a fundamental component of cancer care1 and can be used in the treatment of localized disease, recurrent or metastatic cancer. An estimated 50 percent of people with cancer would benefit from radiation therapy2 either as their sole care option or along with other modalities such as surgery, chemotherapy or immunotherapy.

“While the demand for cancer services is increasing globally, there are certain areas of the world where there continues to be greater gaps in access to radiation medicine. India is a priority due to this disparity as there is a significant deficit in availability of radiation therapy systems compared to the size if its population and incidence of cancer. Our goal with the introduction of Accuray Helix is to close some of these gaps to patient access with our comprehensive solutions,” said Suzanne Winter, president and CEO of Accuray. “The Accuray Helix system combines affordability with automation and tools for enhancing the speed of planning and delivery of radiation. We believe it will enable a broader range of capabilities for facilities that may have resources and staffing for only one system, enabling them to offer state-of-the-art cancer care in their communities.”

Accuray Helix delivers precise, targeted radiation treatments, an important option for the routine cases clinical teams see daily in their practice including breast, cervix, head and neck, gastrointestinal, lung, and prostate. The system’s flexibility and versatility are intended to drive improvements in personalization and patient care, while simultaneously facilitating the treatment of more patients each day, boosting productivity for clinics and enabling them to efficiently manage the growing demand for cancer care.

Important Safety Information
For Important Safety Information please refer to https://www.accuray.com/safety-statement.

ConTIPI Medical Selects EVERSANA to Support U.S. Commercialization of Non-Surgical Medical Device ProVate for Women with Pelvic Organ Prolapse

August 27, 2024

ConTIPI Medical, an innovator in the field of providing non-surgical and disposable solutions for women with various pelvic floor dysfunctions, has selected EVERSANA, a leading provider of global commercial services to the life sciences industry, to support commercialization for the ProVate device in the United States to help women experiencing pelvic organ prolapse (POP).

Approximately 57 million American women over the age of 20 years suffer from POP1. Current treatment methods include largely either invasive surgery with up to a 30% failure rate or the use of non-invasive pessaries which, in most cases, require a physician’s care to insert and remove, and are associated with various adverse events.

ProVate is a ready-to-use, disposable device that is prescribed to patients to be used at home. It is inserted vaginally in small dimensions within a disposable applicator, very similar to the concept of the menstrual tampon applicator, empowering women to take control of their medical condition. The device is available in six sizes and may be used for up to seven days. It also may be removed at any time prior, by a pull on a string, for disposal.

EVERSANA will provide a full array of commercialization services to support the launch of ProVate including pricing, reimbursement and market access, pharmacovigilance, medical communications, sales, regulatory, marketing and commercial operations support, all supported by the company’s leading data and analytics offerings.

“To bring new treatment options to patients requires clinical innovation combined with a proven track record of commercialization success,” said Jim Lang, CEO, EVERSANA. “ConTIPI is pioneering new ways to help women in need, and we’re honored to bring our depth of services to support a successful commercial launch.”

ConTIPI Medical’s mission is to help women suffering from various pelvic floor dysfunctions, currently dealing with POP. ProVate has a 510(k) clearance from the FDA for marketing in the U.S. and bears the CE mark for marketing in Europe.

“We’ve found that it is critical that a commercialization partner understands our mission and vision and has proven success in navigating the complexity of product commercialization and patient adoption,” said Dr. Elan Ziv, MD, OBGYN, Urogynecologist, CEO & Medical Director with ConTIPI Medical. “EVERSANA checks all the boxes, and we look forward to a long and prosperous partnership to bring this new therapy to women in need.”

ProVate is expected to be available for prescribing by clinicians in September 2024. To learn more about ProVate, visit https://contipi.com/provate-device/.

Boston Scientific Obtains CE Mark for ACURATE Prime Aortic Valve System

August 27, 2024

Boston Scientific Corporation (NYSE: BSX) today announced it has obtained CE mark for the ACURATE Prime™ Aortic Valve System, the newest transcatheter aortic valve replacement (TAVR) technology in the company’s structural heart portfolio.

The ACURATE Prime aortic valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy.

The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes force across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes.

“The introduction of the ACURATE Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment,” said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. “Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures.”

The ACURATE Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates,1,2 strong hemodynamic performance,1 as well as unrestricted coronary access for future procedures.

“We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease,” said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. “Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients.”

The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks. For more information on the system, visit https://www.bostonscientific.com/en-EU/medical-specialties/structural-heart/tavi-acurate-prime.html.

*In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale.

6 Reasons to Maintain Regular Visits to Your Physician

August 22, 2024

Making a habit of visiting your primary care physician regularly for checkups and screenings is one of the most proactive, beneficial things you can do for your health. But why are routine doctor visits so important, especially as we age?

There are many crucial reasons to maintain frequent appointments with your physician once you reach middle age and beyond. From monitoring chronic conditions to staying up to date on vaccinations to screening for diseases, your physician has the tools and knowledge to guide you.

Read on as we explore the top reasons to make your doctor visits a consistent priority. Catching issues early and following your doctor’s advice can help you live longer and stay healthier.

1) Preventive Care Saves Lives:

Prevention is better than cure. Regular health exams and screenings allow doctors to detect potential issues in the early stages when they are most treatable. This includes screening for diseases like cancer, heart disease, diabetes, and more. Detecting and addressing any abnormalities right away greatly improves outcomes and saves lives.

For example, your doctor may recommend regular lung cancer screenings if you are a smoker, which could help catch tumors early on when they are still localized and surgically removable. Organizations like www.lungcancergroup.com even provide assistance to those diagnosed with lung cancer due to asbestos or other hazardous exposures. Catching issues early makes a tremendous difference.

2) Vaccinations Protect Health:

Vaccines don’t just help in childhood. Adults need immunizations, too. As we age, our immune systems naturally weaken and become more vulnerable. Vaccines provide an immune boost to help protect against illnesses that pose greater risks for complications.

Your doctor will make sure you receive all vaccinations recommended for your age group and health profile. These may include immunizations to safeguard against pneumonia, shingles, hepatitis, meningitis, tetanus, flu, COVID-19, and other dangerous illnesses. If you have underlying medical conditions or weakened immunity, your physician may advise certain additional vaccines as well.

Routine immunizations are your strongest defense as you age. Childhood vaccines wear off over time. Without proper adult boosters, you have little protection. Let your doctor ensure you receive all recommended vaccines on schedule. Consistent immunizations provide a powerful shield later in life when infections pose greater risks of complications, hospitalization, and even death.

3) Ongoing Condition Management:

If you have any chronic medical conditions such as diabetes, hypertension, heart disease, arthritis, COPD, or anything else requiring regular maintenance and treatment, your physician plays a crucial role. Frequent appointments allow your doctor to closely track any changes in your symptoms, disease progression, side effects, or complications.

Your physician can regularly check important diagnostic tests related to your condition, such as HbA1C levels for diabetes patients, lung function tests for COPD patients, or blood pressure readings for heart patients. Based on the results, your doctor is able to fine-tune your medications, adjust dosages, switch prescriptions if needed, or try different treatment approaches.

This vigilant monitoring and timely tweaking of treatment regimens allows your physician to provide optimal disease management over the long haul. Any flare-ups can be caught early before they worsen. Appropriate referrals to relevant specialists are made promptly when required.

4) Changing Health Needs Assessments:

As we age, our bodies and health risks evolve significantly. Your needs at 65 are far different than at 45 or 25. More frequent well visits later in life allow your doctor to proactively realign your care to match your changing needs.

In your youth as a healthy adult, you may have only needed a standard physical exam every 2-3 years. But now that you are over 50, the picture changes. Much more diligent maintenance and monitoring of your health becomes crucial.

The risks for various age-related diseases increase exponentially as you get older. Your likelihood of developing cancer, heart disease, diabetes, and other serious conditions rises. Subtle symptoms that could reflect underlying issues warrant much more rapid, thorough investigation when you are older.

Consistent appointments allow your physician to closely track how your health status evolves over time. They can order labs and tests specific to your changing risks and needs. Counseling addresses concerns common at each stage of aging. Seeing your doctor frequently keeps your care precisely aligned with your shifting health profile as you get older so that any emerging issues get identified right away before threatening your well-being.

5) Establishing a Trusted Partnership:

Seeing the same primary care physician regularly over many years allows you to establish a relationship of trust, familiarity, and comfort. This continuity of care is invaluable.

When you have an ongoing partnership with your doctor, you can speak more openly and honestly about sensitive health topics that you may not reveal to clinicians who are still strangers. You are more likely to disclose intimate issues, personal habits, family problems, or other factors influencing your well-being when you have a rapport with your physician.

This depth of understanding and trust simply isn’t possible when you sporadically see whichever random physician happens to be available. Continuity with one primary doctor who knows your case inside and out over many years enables the best care.

6) Peace of Mind:

Ultimately, maintaining regular preventive checkups and screenings provides invaluable peace of mind as you age. You can rest easier knowing that any potentially serious emerging health issues will likely be caught very early on when outcomes are better.

Without consistent good visits, you may feel anxious about missing a critical screening or test recommended for your age. But your doctor has you covered, tracking your care vigilantly at routine appointments. They guide you in exactly which screening exams, lab work, immunizations, and other preventive health steps align with your needs and risks at each stage of aging.

As your trusted health partner, your primary care physician has you on the optimal prevention plan customized for your age and risk factors. Consistent check-ins provide reassurance that you are doing everything recommended to protect your well-being as you get older.

Conclusion:

As you age, aim to see your primary care physician at least annually. Discuss how often you need appointments based on your health profile and family history. Address any concerns promptly in between visits, too. Staying current on health exams and tests can truly save your life. So, make regular doctor visits a priority!

Qure.ai Launches FDA-cleared AI Solution for Advanced Lung Nodule Quantification on CT Scans at AABIP 2024

August 22, 2024

Qure.ai, a global innovator in medical imaging AI, has today announced a pivotal 510(k) FDA clearance for its AI-powered chest CT solution – qCT LN Quant. The new AI solution is now available to support radiologists and pulmonologists in analyzing lung nodules on non-contrast chest CT scans and tracking volumetric growth as part of progression monitoring.

qCT LN Quant joins the Qure.ai US AI-powered Lung Cancer care continuum, featuring end-to-end AI solutions to identify, measure, manage, and monitor lung health. These help to support clinicians at healthcare institutions and drive early detection. This includes ‘qXR LN’ for the early detection and localization of lung nodules on chest X-rays to support early lung cancer detection beyond traditional CT-based screening initiatives, and ‘qTrack,’ a multi-modality lung nodule management platform that integrates with Electronic Medical Records (EMRs) to help find, report, collaborate, and prioritize lung cancer patient cases.

qCT LN Quant offers advanced quantitative characterization of solid lung nodules, measuring average, short-axis, long-axis, and effective diameters. It allows clinicians to analyze morphological data across single or multiple thoracic studies, including estimated volume doubling time and tracking of nodules over several time points. Furthermore, it generates detailed 2D and 3D reconstructions, Brock malignancy risk scores, and Fleischner Society guidelines-based management suggestions to support consistent and reliable clinical decision-making. qCT LN Quant is potentially eligible under two CPT codes for reimbursement – tissue quantification CPT 0722T for CT and 3D reconstruction code.

“We are delighted to showcase qCT LN Quant at the American Association for Bronchology and Interventional Pulmonology (AABIP) conference in North Carolina,” states Bhargava Reddy, Chief Business Officer, Oncology at Qure.ai. “This FDA clearance marks a significant milestone for Qure.ai’s mission to enhance lung cancer care in the United States. Already, we’re starting to see the power of AI for incidental pulmonary nodule detection using chest X-ray, across multiple care settings, to boost lung surveillance, especially in states with low lung cancer screening CT uptakes. Now, we have the next stage solution in the AI-optimized patient pathway, to evaluate lung nodules on at-risk patient CT scans, giving precise quantitative characterization, plus tracking volumetric growth over time.”

Javier Zulueta, MD, Chief, Division of Pulmonary, Critical Care and Sleep Medicine at Mount Sinai Morningside, New York, comments, “Medical imaging AI holds immense potential in the battle against lung cancer in the United States. It is great to see the breadth of FDA clearances rolling in to enable the exploration and activation of algorithms that can support radiologists and pulmonologists. This will help to detect lung nodules earlier using chest X-ray, and also analyze them in detail on chest CT.”

Qure.ai has extensive real-world experience with AI deployments at over 3,000 sites in more than 90 countries. It is widely trusted by global institutions, with partnerships, commercial deployments, and research studies underway with AstraZeneca, the UK’s National Health Service (NHS) hospitals, and major teleradiology companies in the UK and US. Qure.ai is headquartered in Mumbai, with regional team offices in New York and London.

MAUI Imaging Emerges From Stealth With $4 Million Department of Defense Contract To Support Trauma Medicine

August 22, 2024

MAUI Imaging, inventor of patented technology that sees anatomy other ultrasounds cannot, today emerged from stealth with the announcement of a $4 million U.S. Department of Defense (US Army Medical Research and Development Command) contract to support trauma medicine across four branches of the military seeking to enable faster diagnosis and interventional care in high volume (mass casualty) and/or resource limited environments.

“With the U.S. military contract and our technology becoming more visible on a broader stage, we’ve decided it’s time to come out of stealth and show what we have been working on,” said MAUI Imaging CEO and co-founder David Specht. “The feedback we have received from physicians and technologists highlights the profound need for a new ultrasound-based technology that enables imaging of all types of tissues. That need is most pronounced in trauma medicine, which is a major focus of MAUI’s collaborative development efforts. Going forward, MAUI will be able to supply the volumetric imaging data for AI tools that predominantly come from CT and MRI.”

MAUI will present a poster describing their breakthrough imaging technology and its potential use in trauma diagnosis and triage at the Military Health System Research Symposium taking place August 26-29, 2024 in Florida. MAUI’s Chief Medical Officer, John Cheronis, MD PhD will present imaging data from the initial studies funded by the MRDC. Additional imaging of trauma pathology is being developed in partnership with Dr. Rosemary Kozar, MD PhD from the University of Maryland Shock Trauma Center and Dr. Matt Bradley, CAPT USN, Uniform Services University of the Health Sciences, a part of the Walter Reed National Military Medical Center, as part of the USAMRDC project.

PCI Pharma Services In Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection

August 21, 2024

PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), has successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire campus. In doing so, PCI becomes the first drug product CDMO to navigate the multi-agency inspection process, a facet of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program, which is focused on the mutual assessment of facilities that manufacture therapies under the organization’s purview.

The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections. For this pilot inspection, two agencies conducted the inspection – one onsite and the other virtually – while an additional five regulatory bodies observed virtually.

“We’re honored to have been selected as the first CDMO to participate in the ICMRA’s pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” said Tom McGrath, VP, Global Quality for Manufacturing & Development at PCI Pharma Services. “The program’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging and ultimately commercializing life-changing therapies.”

PCI’s Bedford campus specializes in sterile fill-finish and lyophilization, two manufacturing processes commonly used with injectable and biologic therapies. PCI recently invested over $100 million in infrastructure enhancements at the site, building upon legacy disciplines toward its current destination: a multi-product, multi-capabilities campus servicing prominent pharma companies, across the drug product lifecycle from development to commercialization. Since PCI’s Bedford campus manufactures a broad array of drugs for both domestic and international markets, the site was an ideal candidate for the multi-agency inspection pilot program.

“At PCI, we are dedicated to bringing lifechanging therapies to patients as expediently as possible, and this welcome new program will further enhance our ability to do exactly that,” said Salim Haffar, CEO of PCI Pharma Services. “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, fast-tracking boost for the pharma industry, providing shorter paths to full-fledged sterile drug product production and commercialization, to the ultimate benefit of pharma companies and the patients they serve.”

Partillion Bioscience Announces Early Access Program for Nanovial Multicell Assays to Enable the Study of Cell-to-Cell Interactions

August 21, 2024

Partillion Bioscience Corporation (“Partillion”), a life science tools company, announced the launch of its Early Access Program for the Nanovial Multicell Assays. This innovative platform is designed to transform the study of cell-to-cell interactions by allowing researchers to co-localize cells within Nanovials, hydrogel nanoliter compartments, offering unprecedented insights into cellular behavior in biologically-relevant context.

The Early Access Program provides select academic and biopharmaceutical partners with the opportunity to integrate this cutting-edge technology into their research workflows, enabling them to explore how a cell’s secretions affect a co-localized target cell with higher precision and scalability than ever before.

Unlocking New Possibilities in Antibody Discovery and Beyond

Nanovial Multicell Assays are particularly well-suited for overcoming key challenges in antibody discovery. Traditional in vitro and in vivo antibody discovery methods are limited to targets that can be produced in a soluble recombinant form, restricting the ability to screen for function-inducing antibodies that require target expression on cell membranes. This is a significant obstacle when targeting proteins that maintain their physiological structure only in their native cellular context, such as G-protein coupled receptors (GPCRs) and immune checkpoint proteins.

A recent pre-print, titled “Function-First Plasma Cell-Based Antibody Discovery Using Hydrogel Nanovials,” available on BioRxiv, highlights the efficacy of this platform in a new high-throughput multicell screening workflow. The study demonstrated co-localization of antibody secreting cells (ASC) and antigen expressing cells within Nanovials. Plasma B cells were analyzed, resulting in the identification of diverse antibodies with high affinity, multiple epitope coverage, and high potential for drug development. Notably, the workflow yielded antibodies against the PD-1 immune checkpoint protein with cell binding characteristics (EC50s) comparable to those of clinically used therapeutics.

“Our Nanovial Multicell Assays are a game-changer, opening up new possibilities in research areas where the precise colocalization of cells is essential for studying complex cell-to-cell interactions or screening for therapeutic molecules released by one cell that act on another” said Joe de Rutte, Co-founder and CEO of Partillion. “By enabling these complex screens, all using standard life science instrumentation, we’re enabling scientists to scale studies of how cells interact with other cells, whether it’s better understanding tumors in the context of immune cells in their microenvironment, host-pathogen interactions or developing the next-generation therapies.”

Join the Early Access Program

Partillion Bioscience invites researchers and biopharmaceutical companies to apply for the Nanovial Multicell Assays Early Access Program to gain first-hand experience with their new workflows. Participants will have the unique opportunity to leverage Nanovial Multicell protocols and reagents for their research. For more information about the Nanovial Multicell Assays and how to join the Early Access Program here.

XII Medical Raises $45 Mil in Series B Financing

August 21, 2024

XII Medical, Inc., a clinical-stage medical technology company developing innovative therapies for obstructive sleep apnea, today announced the closing of a $45 million Series B equity financing. The financing was led by Omega Funds and joined by new investor Intuitive Ventures.

Existing investors also participated, including founding investor Cleveland Clinic, Ajax Health, Longview Ventures (an affiliate of Broadview Ventures), Aperture Venture Partners, JobsOhio Growth Capital Fund, and an undisclosed strategic investor. Funds will be utilized to further product and clinical development. XII Medical has developed a state-of-the-art, patient-centric neuromodulation therapy designed to enhance the quality of life for the millions of people suffering from obstructive sleep apnea.

Obstructive sleep apnea (OSA) is a disorder in which the muscles in the throat temporarily relax, causing blockage of the airway during sleep. It is estimated that 425 million people, globally, have moderate to severe OSA requiring treatment. Current treatment options are overly burdensome to patients and physicians, leaving a significant number of patients untreated, undertreated, and at risk of severe health complications.

Despite advancements in obstructive sleep apnea therapies, challenges remain that prevent millions of people from receiving adequate treatment,” commented Saoussen Ben Halima, PhD, Sr. Associate, Omega Funds. “We are thrilled to lead this round. We believe XII Medical developed a ground-breaking platform technology to simplify treatment, expand access, and improve outcomes for patients.”

“XII Medical’s transformative technology is poised to help the hundreds of millions of those suffering from OSA,” said Murielle Thinard McLane, President and Managing Partner of Intuitive Ventures. “Their neuromodulation therapy addresses patient compliance issues while also offering a high quality, minimally invasive solution with a streamlined surgical approach and smaller, flexible and easier to implant technology than current solutions.”

“XII Medical is committed to improving the lives of patients with obstructive sleep apnea. The significant support from our investors will allow us to expand our exceptional team and collaborate with best-in-class partners to advance our technology and clinical research,” commented Garrett Schwab, President and CEO of XII Medical.

“XII Medical has made significant progress and we are pleased to welcome these outstanding new investors to our syndicate,” commented Anthony Natale, M.D., Executive Chairman of XII Medical. “I share their excitement in the pioneering work the XII Medical team is doing to make best-in-class OSA therapy accessible to all who require it.”

Lucid Diagnostics Announces Publication of Analytical Validation Study of EsoGuard® for Early Detection of Esophageal Precancer and Cancer

August 20, 2024

Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”) a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), today announced the peer-reviewed publication of an analytical validation study of its EsoGuard® Esophageal DNA test for the diagnosis of esophageal precancer (Barrett’s Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid’s EsoCheck® Esophageal Cell Collection Device. The manuscript, entitled Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck®, a Non-Endoscopic Esophageal Cell Collection Device, has been published in the peer-reviewed journal Diagnostics, and is currently available via open access online.

“This analytical validation study strongly complements EsoGuard’s extensive peer-reviewed, published clinical validity and clinical utility evidence base,” said Suman Verma, M.D., PhD, Chief Scientific Officer at Lucid Diagnostics. “The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory.”

The publication details comprehensive studies demonstrating excellent analytical performance of the EsoGuard assay on samples collected with EsoCheck, including 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% inter- and intra-assay precision. EsoGuard utilizes next-generation sequencing (NGS) to detect DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1), which have been shown to be associated with conditions along the BE-EAC spectrum.

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Accuray Incorporated (NASDAQ: ARAY) announced today the company has received CE Mark for Accuray Helix™, a CT-guided helical radiotherapy system designed to provide high-performance and high-throughput.

Boston Scientific Corporation (NYSE: BSX) today announced it has obtained CE mark for the ACURATE Prime™ Aortic Valve System, the newest transcatheter aortic valve replacement (TAVR) technology in the company’s structural heart portfolio.

1) Preventive Care Saves Lives:

2) Vaccinations Protect Health:

3) Ongoing Condition Management:

4) Changing Health Needs Assessments:

5) Establishing a Trusted Partnership:

6) Peace of Mind:

Conclusion:

XII Medical, Inc., a clinical-stage medical technology company developing innovative therapies for obstructive sleep apnea, today announced the closing of a $45 million Series B equity financing. The financing was led by Omega Funds and joined by new investor Intuitive Ventures.

Medical Device News Magazine