Fixing Eligibility at the Point of Care: The Missing Link in Medical Device...
MTI Viewpoints Insights shared by industry relative to healthcare and the advancement of medical technology. Peter Justen is Founder and CEO of AmeriTrust Solutions. He works at the intersection of...
View ArticleSignatera CDx Gets FDA Nod as Companion Diagnostic for Muscle-Invasive...
Natera, Inc. today announced that the U.S. FDA has approved Signatera CDx as a companion diagnostic (CDx) for use with adjuvant atezolizumab (Tecentriq) immunotherapy in Muscle-Invasive Bladder Cancer...
View ArticleBoston Scientific announces strategic investment in MiRus LLC
Boston Scientific Corporation announced it has invested $1.5 billion in return for an approximately 34% equity stake in MiRus LLC, a privately-held company developing and commercializing proprietary...
View ArticleMedtronic’s Updated Mitral Valve, Mosaic Neo, Gets FDA approval
Medtronic plc received U.S. Food and Drug Administration (FDA) approval for its Mosaic Neo mitral bioprosthesis and has launched the valve in the U.S. The updated valve is thoughtfully designed to be...
View ArticleSonire Therapeutics Initiates First U.S. Clinical Study of Ultrasound-Guided...
Sonire Therapeutics announced the initiation of its first U.S. clinical trial, SUNRISE-II, evaluating its proprietary High-Intensity Focused Ultrasound (HIFU) therapy system for the treatment of...
View ArticleJohnson & Johnson Enters Agreement to Acquire Atraverse Medical
According to a company press release, Johnson & Johnson has entered into a definitive agreement to acquire Atraverse Medical, Inc., a privately-held medical device company pioneering...
View ArticleenVVeno Medical Receives FDA IDE Approval for Non-Surgical Replacement Venous...
enVVeno Medical has received the investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for a pivotal study involving a non-surgical replacement venous valve....
View ArticleMedtronic Gains CE Mark for Stealth AXiS surgical system
Medtronic has received CE mark for the Stealth AXiS surgical system which integrates planning, navigation, and robotic execution into a single, modular platform. The Stealth AXiS system is indicated...
View ArticleMedtronic Continues Cardiovascular Care Growth with Completion of CathWorks...
Medtronic announced it has completed its acquisition of CathWorks, a developer of medical devices for coronary artery disease diagnostics and treatment. The acquisition follows a 2022 strategic...
View ArticleThe Structural Tension at the Heart of MedTech
MTI Viewpoint Insights shared by industry relative to healthcare and the advancement of medical technology. Moshe Barel is the CEO and co-founder of AccuLine. He has over two decades of experience...
View ArticleCMS, FDA Announce RAPID Coverage Pathway to Accelerate Device Reimbursement
The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced an expedited pathway for Device Makers to potentially expedite access to certain...
View ArticleStyker Adds IVL Technology to Peripheral Vascular Portfolio with Amplitude...
With the acquisition of Amplitude Vascular Systems announced recently, Stryker joins the IVL technology race with Johnson & Johnson and Boston Scientific. Industry analysts noted cardiovascular...
View ArticleFDA Reminds More Than 2,200 Sponsors and Researchers to Disclose Trial Results
The U.S. Food and Drug Administration has reminded more than 2,200 medical product companies and researchers of the requirements to submit certain clinical trial results information to...
View ArticleBD Announced Application of CE Mark for the Liverty TIPS Stent Graft
BD announced application of CE Mark for the Liverty TIPS Stent Graft, delivering innovation to portal hypertension care across the European Union. Designed to expand treatment options for patients with...
View ArticleEndospan Receives FDA Approval for the NEXUS Aortic Arch Stent Graft System
Endospan announced that the U.S. Food and Drug Administration (FDA) has approved the NEXUS Aortic Arch Stent Graft enabling commercial launch of the NEXUS System in the US. According to the company...
View ArticleInVera Medical Receives FDA Clearance for Non-Thermal Chronic Venous Disease...
InVera Medical has received FDA 510(k) clearance for the InVera Infusion Device, a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins,...
View ArticleAllevion Medical Receives 510K Clearance for Vantage Spinal Decompression System
Allevion Medical announced the FDA 510(k) clearance of Vantage, a fully disposable, sterile system designed to simplify and enhance minimally invasive lumbar decompression procedures associated with...
View ArticleSerenity Medical Receives FDA Humanitarian Device Exemption for IIH Venous Stent
Serenity Medical announced FDA Humanitarian Device Exemption (HDE) approval for its novel River stent. The River stent is for the treatment of severe idiopathic intracranial hypertension (IIH) in adult...
View ArticleBeyond Reimbursement: Why Market Access is MedTech’s Strategic North Star
MTI Viewpoint Insights shared by industry relative to healthcare and the advancement of medical technology. Across industry, the Market Access (MA) function has evolved well beyond its traditional role...
View ArticleTwo GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA...
The Advanced Technology Development Center (ATDC) in Georgia Tech’s Office of Commercialization announced two of its health technology (HealthTech) portfolio companies, Nephrodite and OrthoPreserve,...
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