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Innovative Technology Life Sciences Medical Devices

Maynard Nexsen

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

Maynard Nexsen on

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

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Epstein Becker & Green

FDA Oversight of AI Software Developed by Health Care Providers

Epstein Becker & Green on

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

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

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

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

Polsinelli

CMS Proposes Medicare Coverage Pathway for FDA-Designated Breakthrough Technologies

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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

MoFo Life Sciences

Bill Proposes 10 Additional Years for COVID-19 Inventions

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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

Hogan Lovells

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies

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On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP), effectively following through on the...more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Hogan Lovells

FDA announces planned modernization of 510(k) pathway and seeks a more active role in driving technological innovation

Hogan Lovells on

On 26 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren issued a joint statement proposing to rebrand and modernize the...more

Hogan Lovells

The EU regulatory challenges and liability risks associated with 3-D printed medical devices

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In this hoganlovells.com Q&A, Hogan Lovells counsel Fabien Roy addresses EU regulations that apply to medical devices that are produced using 3-D printing technologies....more

Robins Kaplan LLP

Lessons for Life Science and Medical Device Companies Post-Nautilus

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Under the U.S. Patent laws, claims must particularly point out and distinctly claim what the inventor understands her invention to be. Up until three years ago, the inquiry for determining indefiniteness was to ask whether...more

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