News & Analysis as of

Innovative Technology Medical Devices

Foley Hoag LLP

Fostering More Access to Medical Devices: FDA’s Efforts to Advance Health Equity

Foley Hoag LLP on

On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with...

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This week, Heather and Lauren welcome Kimberlee Steele, the Managing Director for North America of SHL Medical, a world leader in the design, development, and manufacture of autoinjectors, pen injectors, and drug delivery...more

Blank Rome LLP

Innovation in Spine Health

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Episode 8: Innovation in Spine Health In this episode of BRight Minds in Healthcare Delivery, Eric J. Muehlbauer joins host Eric Tower for a conversation about his storied career at the North American Spine Society...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

McDermott Will & Emery

Key Takeaways | Pharma and MedTech Services Market Overview With McKinsey & Company

McDermott Will & Emery on

During this session, McDermott Partner Kristian Werling and Jeff Smith, a senior partner at McKinsey & Company, shared insights across the pharma and MedTech services industries, including key trends and opportunities shaping...more

Hogan Lovells

Implications of the EU AI Act on medtech companies

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The European Union has introduced comprehensive regulations for artificial intelligence (AI) systems, encapsulated in the EU AI Act (AI Act). The objective of the AI Act is to ensure that AI systems in the EU are safe,...more

Husch Blackwell LLP

Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI

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The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW),...more

Franczek P.C.

Department of Education Dear Colleague Letter Provides Updated AT Device Guidance

Franczek P.C. on

On January 22, 2024, the United States Department of Education (“USDOE”) issued a Dear Colleague Letter regarding supporting students with disabilities who require assistive technology (“AT”) in order to receive meaningful...more

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

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Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

McGuireWoods LLP

Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare

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Bradd Busick, senior vice president and chief information officer for MultiCare, joins hosts Holly Buckley and Kristen McDermott Woodrum on this episode of Health+Tech to provide insights into MultiCare’s recent successes in...more

Faegre Drinker Biddle & Reath LLP

Why 3D Printing Doesn’t Have to be a Pandora’s Box for IP Rights

Personal 3D printing has seen leaps in advancement in recent years, allowing users to render increasingly sophisticated creations from the comfort of their own home. These creations can include anything from gaming miniatures...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Faegre Drinker Biddle & Reath LLP

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

Knobbe Martens

Osteoconductive Filament Developed for 3D Printed Implants

Knobbe Martens on

Evonik is a specialty chemical company developing biomaterials that serve as metal-free alternatives to traditional bone implants. Evonik’s VESTAKEEP product line includes an osteoconductive polyether ether ketone (PEEK) – a...more

MoFo Life Sciences

Rescinding The MCIT/R&N Final Rule, CMS Seeks New Approaches For Innovative Technology Coverage

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On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) issued a final rule rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” final rule (MCIT/R&N). As...more

Knobbe Martens

NeoChord Announces Successful Completion of First-in-Human Procedure with its Mitral Chordal Repair Technology

Knobbe Martens on

NeoChord, Inc. (“NeoChord”) announced on October 4, 2021 that it successfully completed a first-in-human procedure with the NeXuS Transcatheter Mitral Chordal Repair (TMVr) device NeoChord is developing. NeoChord also...more

MoFo Life Sciences

CMS Proposes To Repeal MCIT Final Rule

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Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” final rule (the “Proposed...more

Goodwin

Exactly One Year Later, CMS Reverses Course on Covering Innovative MedTech

Goodwin on

In September 2020, the Centers for Medicare & Medicaid Services (CMS) proposed a new rule that would expedite Medicare coverage for medical technology approved through the Food & Drug Administration’s (FDA’s) “Breakthrough...more

Hogan Lovells

CMS delays “reasonable and necessary” definition, expedited breakthrough device coverage process rule

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On March 17, 2021, the Centers for Medicare & Medicaid Services (CMS) published a notice in the Federal Register delaying the effective date of the final rule titled, “Medicare Program; Medicare Coverage of Innovative...more

Mintz - Health Care Viewpoints

CMS Proposes Changes to Medicare’s Coverage Determination Criteria and Expedites Approval of Breakthrough Devices

The Centers for Medicare and Medicaid Services recently issued a proposed rule that would grant Medicare coverage to breakthrough medical devices immediately upon FDA approval. The rule also proposes to codify a new...more

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

Polsinelli on

On September 1st, the Centers for Medicare & Medicaid Services (CMS) proposed a rule offering medical device manufacturers Medicare coverage upon FDA clearance or approval when their products have been designated by the U.S....more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes to Streamline Medicare Coverage Process for Innovative Technology and Consider Commercial Coverage in “Reasonable and...

- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more

Shook, Hardy & Bacon L.L.P.

Surgical Robots Risk Greater Legal Costs Than You May Think

It’s no secret that defending against product liability lawsuits can be costly. But surgical robot manufacturers sometimes ask me to give them hard numbers. To read the tea leaves and estimate how much they’ll have to spend...more

Dechert LLP

fintech NEXT: Developments on Digital Assets and Blockchain

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Blockchain technology continues to mature and gain acceptance for a wide range of potentially disruptive financial and commercial uses. In the wake of COVID-19, we have seen an increased focus on the research and development...more

MoFo Life Sciences

Bill Proposes 10 Additional Years for COVID-19 Inventions

MoFo Life Sciences on

A proposed bill offers a potential boon to patent owners. If passed, the “Facilitating Innovation to Fight Coronavirus Act” will add ten years to the patent term of eligible inventions. However, the bill will temporarily...more

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