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Technology Medical Devices Healthcare

McDermott+

Back for seconds: digital health policies in the CY 2026 PFS proposed rule

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It’s been more than two weeks since the release of the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule. We’ve had a chance to digest our initial helping and now we’re ready for seconds. We thought we would see...more

Verrill

Legal Readiness for AI in Healthcare: A Provider’s Quick Guide

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Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more

Davis Wright Tremaine LLP

CMS Launches WISeR Model to Curb Overuse of Medicare Services

The Centers for Medicare and Medicaid Services (CMS) is looking to reduce the volume of "low value" services furnished to Original Medicare beneficiaries through the recently announced Wasteful and Inappropriate Service...more

A&O Shearman

Federal Circuit Invalidates Patent For Angioplasty Catheter Based On Applicant Admitted Prior Art

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The Federal Circuit recently issued a precedential decision in Shockwave Med., Inc. v. Cardiovascular Sys., Inc. (CSI), affirming-in-part and reversing-in-part the Patent Trial and Appeal Board’s (PTAB) decision, and...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces AI Councils Amid Calls for Greater Agency Transparency

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more

MoFo Life Sciences

Key Developments in MedTech M&A: Momentum Despite Macroeconomic Uncertainty

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2024 was a challenging year for M&A activity in the medical technology (“MedTech”) industry. Although some sectors experienced a rebound in deal volume, MedTech dealmakers were disproportionately affected by a difficult...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

Knobbe Martens

Boston Scientific Agrees to Acquire Sonivie Ltd. For up to $540 Million

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Boston Scientific recently announced it entered into a definitive agreement to acquire SoniVie Ltd. According to the press release, SoniVie is a privately held medical device company that developed the TIVUS Intravascular...more

McDermott Will & Schulte

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 6, October 2024

Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more

Butler Snow LLP

The Wearable Revolution: How to Use Personal Health Device Data in Litigation

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Wearable technology compiles extensive information on our bodily systems—including activity levels, menstruation and fertility, exercise activity and attainment, food consumption, weight, sleep, noise exposure, heart rate,...more

McDermott Will & Schulte

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 1, January 2024

The Current Status of Privacy Laws Across the United States - Unlike the General Data Protection Regulation (GDPR) in the European Union (EU), the United States does not have a nationwide comprehensive data privacy law....more

Sheppard Mullin Richter & Hampton LLP

Day 1 Notes from the 42nd Annual J.P. Morgan Healthcare Conference

At the first day of the J.P. Morgan Healthcare Conference, “[T]he answer to the ultimate question of life, the universe and everything is 42.” Recognize that famous line? No, it’s not something from ChatGPT, it’s Douglas...more

Foley & Lardner LLP

Protecting Innovations in SaMD & Biomedical Applications

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With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more

Perkins Coie

Washington State’s New My Health My Data Act Will Likely Result in Insurance Coverage Disputes

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Washington state recently passed the My Health My Data Act (the Act), which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes. The measure is intended to protect...more

Jones Day

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

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Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more

White and Williams LLP

“Magic Arms”: The Future of 3D Printing and Its Impact on Healthcare

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In the past, doctors and researchers were limited in the types of individualized devices they could create for their patients; now, 3D printing presents the possibility of creating almost any device, limited only by their...more

Stinson LLP

FDA Eases Medical Evaluation and Recordkeeping Requirements for Hearing Aids

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On Wednesday, the Food and Drug Administration (FDA) released a new guidance document indicating that it will not enforce the medical evaluation and recordkeeping requirements (21 CFR §801.421(a) and (d)) prior to the...more

Robins Kaplan LLP

The Tech Industry’s Next Frontier?

Robins Kaplan LLP on

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

Stinson LLP

Off-Label Promotion —To Speak or Not To Speak?

Stinson LLP on

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications...more

Knobbe Martens

PilotFish Announces MedDevice Connection App

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Applied PilotFish Healthcare Integration, Inc. (APHII) recently announced a new application called HealthConnect. APHII is the healthcare division of PilotFish Technology, a provider of middleware solutions for the...more

Stinson LLP

FDA Attempts to Clarify Enforcement Position Regarding Evolving Health Technology

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Recently, the U.S. Food and Drug Administration (FDA) has issued a flurry of guidance and draft guidance in an effort to better define the types of products that the FDA will choose to actively regulate. In one of these...more

Knobbe Martens

21st Century Cures Congressional Panel Unveils Medical Technology Proposals

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On January 27, 2015, members of the House Commerce and Energy Committee unveiled a set of legislative proposals aimed at speeding up the development of new medical technology. The 21st Century Cures panel, a bipartisan...more

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