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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...

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Signatera 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...

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Boston 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...

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Medtronic’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...

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Sonire 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...

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Johnson & 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...

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enVVeno 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....

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Medtronic 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...

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Medtronic 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...

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The 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...

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CMS, 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...

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Styker 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...

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FDA 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...

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BD 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...

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Endospan 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...

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InVera 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,...

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Allevion 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...

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Serenity 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...

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Beyond 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...

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Two 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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