Topic
Medical Device
1,528 published works
BioSlice Blog
Virtual and Digital Health Digest – October 2026
By Alexander Roussanov, Fabien Roy, James Castro-Edwards, Emma Elliston, Sofia Holmquist, Ana Gonzalez-Lamuno, Heba Jalil
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health digest. This digest covers key virtual and digital health regulatory and public policy developments during September 2026 from the EU…
Duane Morris Life Sciences Law
When Does Tissue Processing Cross the Regulatory Line and Require Pre-Market Review?
By Frederick R. Ball, Coleen W. Hill and Kelechi AnyatonwuFor developers of human cells, tissues, and cellular and tissue-based products, classification can determine the shape of an entire regulatory strategy…
BioSlice Blog
UK government announces indefinite recognition of EU CE marks for medical devices and in vitro diagnostics
By Adela Williams, Christopher Bates
On 21 October 2026, the UK Government confirmed that it will make the unilateral recognition of EU CE marks for medical devices and in vitro diagnostic devices (IVDs) in Great…
Covington Digital Health
UK Medical Device Update: Developments in AI, Proposed GB Licensing Framework and Indefinite CE Mark Recognition
By Sarah Cowlishaw, Dan Spivey
Recent weeks have proved of great interest to the UK medical device industry, with various key developments emerging. Foremost among these, on 10 September 2026, the National Commission into the…
Inside EU Life Sciences
UK Medical Device Update: Developments in AI, Proposed GB Licensing Framework and Indefinite CE Mark Recognition
By Sarah Cowlishaw, Dan Spivey
Recent weeks have proved of great interest to the UK medical device industry, with various key developments emerging. Foremost among these, on 10 September 2026, the National Commission into the…
The Consult
FDA Proposes Premarket Recommendations for Robotically Assisted Surgical Devices
On September 25, 2026, the U.S. Food and Drug Administration (FDA) released draft guidance that sets out the agency’s recommendations on nonclinical testing, clinical data, and labeling for premarket submissions…
GoodLifeSci
A More Competitive MedTech Landscape in the EU? What the MDR/IVDR Revision Could Mean for MedTech Manufacturers and Investors
By Josefine Sommer, Michelle Gandolfo, Belinda Baum, Anna-Shari Melin, Eva Von Mühlenen, Dr. Chris Boyle
The EU’s targeted revision of the medical device and in vitro diagnostics framework has entered a more active phase, with nearly 800 amendments tabled in Parliament in July 2026 and…
HLC - All Publications
FDA’s draft RASD guidance codifies years of existing review practice for general surgical robotics systems
By Cadwalader Wickersham & Taft
The U.S. Food and Drug Administration (FDA) issued new draft guidance on premarket submissions for robotically assisted surgical devices (RASDs). We see the guidance as a notable maturation of FDA's…
Drug & Device Law
The Bonus Track Survives; PMA Preemption Cuts the Rest
Every so often, the song nobody wanted turns out to be the one that lasts. Radiohead almost left “Creep” off their debut album because the band itself was embarrassed by…
Napoli Shkolnik Blog
GLP-1 Drugs and NAION: What We Know About the Potential Vision Risk
Glucagon-like peptide-1 agonists (GLP-1s) are presented with catchy jingles set to familiar tunes, and polished advertisements featuring beaming spokespersons that boast of its success. Pharmaceutical companies want consumers to know that…