Medical Device News
Wednesday, November 6, 2024

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Medical Device News

What are the future trends of medical devices?  In the rapidly evolving landscape of healthcare, staying informed about the latest advancements in medical technology is essential for professionals and enthusiasts alike. Medical Device News Magazine serves as a vital resource, offering insights into cutting-edge innovations, regulatory developments, and industry trends that impact both patient care and business strategies. This publication aims to bridge the gap between healthcare professionals, investors, and the medical device industry, providing a comprehensive platform of medical device news that can result in discussions on medical device/biotechnology advancements and their implications for the future of medicine.

Read on as we explore the intersection of technology and healthcare, facilitating informed decision-making and fostering collaboration within this dynamic field. Inquire about advertising. Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

Industry Expert Byline

Transforming Diabetes Care: Why CGM Hardware Must Evolve for the Type 2 Population | By Dr. Chris Dawson, Head of Biosensing at TTP

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The landscape of diabetes management is transforming, as continuous glucose monitoring (CGM) devices expand beyond Type 1 diabetes and into a rapidly growing Type 2 market. Changes to regulatory approvals and insurance coverage driven by improved patient outcomes have opened the door for non-insulin-dependent Type 2 patients to access CGM. Device manufacturers now face a new frontier: designing CGM hardware that meets the unique needs of an increasingly diverse patient population. For CGMs to realize their full potential in Type 2 diabetes management, it’s critical to rethink hardware design to cater to this population’s distinct requirements, improving usability, flexibility, and the quality of care.
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Medical Device News Updates

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”
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Mergers & Acquisitions & Funding

Boston Scientific Announces Agreement to Acquire Cortex, Inc.

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Nick Spadea-Anello, global president, Electrophysiology, Boston Scientific said, "We believe the addition of the Cortex technology complements our electrophysiology portfolio with a differentiated cardiac mapping offering to assist with complex AF cases."

Carl Marks Securities Successfully Advises Kewaunee Scientific Corporation on $55 Million Acquisition of Nu Aire

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“We have maintained an advisory relationship with Kewaunee for many years and are proud to have played a role in the successful strategic acquisition of Nu Aire by Kewaunee,” added Evan Tomaskovic, Managing Partner at Carl Marks Advisors. “It is gratifying to assist a 100-year-old business complete a key acquisition of a more than 50-year-old family-owned business, fortifying the legacies of both world-class organizations.”
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Clinical Trials & Updates

Elixir Medical Reports | LithiX HC-IVL System Data Demonstrate Sustained Safety and Efficacy at Six Months

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“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”

SPYRAL HTN-ON MED Study Update | Shows significant, consistent, long-term blood pressure lowering effect at two years

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"These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. "Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs."
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Biotechnology News

Immorta Bio Reports | SenoVax™ Reduces Growth and Stops Metastasis of Aggressive Breast Cancer Using its First-In-Class Immune Stimulatory Therapy

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SenoVax has previously been demonstrated to reduce lung cancer growth1, which was the subject of the Company's IND #307452. It has also been shown to accelerate recovery of blood cell production after chemotherapy notes Immorta Bio.

BioHub Maryland Opens New Biopharma Workforce Training Center in Montgomery County’s Life Sciences Corridor

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BioHub Maryland is a skills-first workforce development initiative of the Maryland Tech Council (MTC), the state’s largest life sciences and technology trade association. Its mission is to accelerate the growth of the life sciences industry by expanding the state’s biopharma manufacturing talent pipeline.
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Headlines

Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis

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“This latest expansion of coverage by Noridian means that even more patients could be positively impacted by PlaqueIQ, which offers the only non-invasive measurement of lipid-rich necrotic core, a vulnerable, high-risk component of plaque that can lead to heart attack and stroke,”4 said Kelly Huang, CEO of Elucid. “These recent decisions from five of the seven MACs recognize the importance of new technologies like ours that can help quantify and classify coronary artery plaque to help physicians reduce the clinical and economic burden of cardiovascular disease.”

Mediso Introduces True Theranostic TheraMAX SPECT/CT

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The TheraMAX is equipped with three, large surface detectors (up to 5x larger than 12-detector CZT systems) surrounding the patients completely (360°). The 15.9mm thick NaI crystals ensure improved sensitivity for high energy photons, while the high-density sensor arrangement (123 PMT per detector head) allows high spatial resolution leading to PET-like image quality in all NM applications.
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Market Reports

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Hospitals In the News

Delray Medical Center First Hospital in Palm Beach County to Successfully Implant New Dissolvable Stent for People with Chronic Limb Threatening Ischemia Below-the-Knee

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The procedure was completed by vascular surgeon Dr. Joseph Ricotta, National Medical Director of Vascular Surgery and Endovascular Therapy for Tenet Healthcare and Professor of Surgery and Program Director of the vascular surgery fellowship at Florida Atlanta University School of Medicine.
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Executives Making Headlines

Jason Whiting Appointed CEO of Avation Medical

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Jason Whiting has more than 25 years of experience in the MedTech industry, driving innovation and adoption of new technologies in the implantable, capital equipment, and wearable markets.

Jay Hallinan Appointed Chief Commercial Officer of Q’Apel Medical

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Jay Hallinan will lead the company's global sales and marketing organization, oversee Q'Apel's commercial strategy and drive revenue growth across Q'Apel's expanding product portfolio.
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FDA

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

Christopher M. Owens, President and Chief Executive Officer of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favorable conclusion will allow the company to complete and pursue a PMA market application for MAGNITUDE with the FDA.”

Exactech Reports the FDA Clearance of Truliant® Porous 3D Tibial Implant for Knee Replacement Surgery

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Non Profit News

New Paper Underscores Inflammation’s Role in Atherosclerosis

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Peter Libby, MD, President, of the International Atherosclerosis Society and Chair of the White Paper Expert Panel said, "Atherosclerosis is a primary cause of cardiovascular disease, the leading cause of death worldwide. This paper underscores the persistent need for a more complete understanding of the role of inflammation in atherosclerosis progression among physicians globally, how to identify such inflammation, and how to mitigate the inflammation-associated risk of adverse cardiovascular events. These steps are of the utmost importance for the development of effective treatment strategies that can reduce the morbidity and mortality caused by atherosclerotic cardiovascular disease."

Study: Private Equity Acquisitions in Cardiology on the Rise

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“Policymakers and clinicians have raised concern about the growing presence of private equity in other medical specialties. Although cardiology is an attractive target for private equity firms, little is known about the number and types of practices that are being acquired,” said Senior Author Rishi K. Wadhera, MD, MPP, MPhil, a cardiologist at Beth Israel Deaconess Medical Center and associate professor at Harvard Medical School in Boston. “Private equity acquisitions in other specialties have been shown to decrease quality and increase costs, so it is critical to understand the impact on cardiology.”

CMT Research Foundation Invests in ReviR Therapeutics Research to Pioneer Small Molecule Therapeutics for CMT1A

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"Collaborating with ReviR Therapeutics aligns perfectly with CMTRF's mission to accelerate the development of therapies that can halt or even reverse the progression of CMT," says Cleary Simpson, CEO of the CMT Research Foundation. "Their cutting-edge technology has the potential to transform the lives of those living with this chronic condition by providing a non-invasive, potent, and easily administrable treatment option."

RSNA Reports: Brain Connectivity on MRI Predicts Parkinson’s Disease Progression

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RSNA notes: The findings support the theory that functional and structural connections between brain regions may significantly contribute to Parkinson’s disease progression.
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Nurses Corner

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Laudio Expands Work With Children’s National Hospital to Include Nurse Educators

“Setting nurses up for success, supporting them effectively, and ultimately retaining them requires increasingly proactive, comprehensive strategies,” said Tom Hills, EVP of Client Engagement at Laudio. “We are excited to welcome nurse educators at Children’s National into the Laudio community.”
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American Academy of Nursing Announces the 2024 Class of New Fellows

The newest Fellows represent 37 states, the District of Columbia, Guam, and 14 countries. Their expansive body of knowledge will soon bolster the collective impact of over 3,000 Academy Fellows who together, leverage their expertise to advance the Academy’s vision of healthy lives for all people.
Renowned Vascular Surgeon Dr Frank Veith Unveils Dark Side Of The Medical Profession In Revealing New Memoir

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