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Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

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On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Hutchison PLLC

Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley

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What if the key to understanding and improving brain health lies in a breakthrough approach to neurodata? For Rob Cooley, founder and CEO of Nuream, unlocking the potential of brainwave data has the power to transform...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Reinforcement learning pioneers win Turing Award, McDonald’s brings AI to the fast-food restaurant, “cheating”...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Knobbe Martens

Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow

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A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from USD 97.62 Billion in 2024 to USD 178.15 Billion by 2034: The rapid increase in the global market size of...more

Benesch

Dialysis & Nephrology Digest - February 2025

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A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Ankura

HLTH 2024: 9 Key Observations Steering Healthcare into 2025

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Every year, 12,000 leaders in the healthcare industry meet at HLTH. This year's conference covered all aspects of the healthcare ecosystem, and here are the nine that we should watch as we enter the new year....more

Nelson Mullins Riley & Scarborough LLP

Bipartisan House Task Force Report Outlines Key Areas of AI Focus for Health Care

As the New Year begins, questions surrounding how recent election results will impact technology regulation across industries loom large. It’s hardly a bold prediction that artificial intelligence (“AI”) and the regulation...more

Mintz - Venture Capital & Emerging Companies...

MintzTech Connect Industry News: Spotlight on Surgimatix, Inc

Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more

Jones Day

FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications

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As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

Foley Hoag LLP

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

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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

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

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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

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

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

Knobbe Martens

Osteoconductive Filament Developed for 3D Printed Implants

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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

Hogan Lovells

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

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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

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