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Legal news related to Medical Devices

5 articles

Regulatory
•4 min read

FDA Approves First Medical Device for Pancreatic Cancer Treatment

The U.S. Food and Drug Administration has approved a first-of-its-kind medical device specifically designed to treat adult patients with locally advanced pancreatic cancer. This approval represents a new treatment option for patients facing one of the most challenging forms of cancer.

•First-ever FDA approval of a medical device specifically for locally advanced pancreatic cancer treatment
•New treatment option for patients with limited therapeutic alternatives in one of the deadliest cancers
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Federal Circuit
•4 min read
Federal Circuit Court of Appeals

Federal Circuit Rules in Barry v. DePuy Synthes Patent Case

The U.S. Court of Appeals for the Federal Circuit issued a decision January 20, 2026, in *Barry v. DePuy Synthes Companies*, a patent infringement case involving medical device technology. The case originated from a 2017 lawsuit in the Eastern District of Pennsylvania.

•Federal Circuit issued decision in patent infringement case involving medical device technology
•Case involved allegations that DePuy induced surgeons to infringe Barry's three patents
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Regulatory
•4 min read

Federal Court Blocks Edwards Lifesciences Medical Device Acquisition

The U.S. District Court for the District of Columbia granted the Federal Trade Commission's preliminary injunction request on Jan. 9, blocking Edwards Lifesciences' proposed $945 million acquisition of JenaValve Technology. The FTC argued the deal would reduce competition in the market for transcatheter aortic valve replacement devices that treat life-threatening heart conditions.

•Federal court granted FTC preliminary injunction blocking Edwards' $945 million JenaValve acquisition after six-day trial
•Deal would have combined only two companies with ongoing TAVR-AR device clinical trials in the United States
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Regulatory
•4 min read

FDA Launches TEMPO Pilot to Expand Digital Health Device Access

The Food and Drug Administration announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program, a first-of-its-kind voluntary initiative designed to expand patient access to digital health devices for chronic disease management while maintaining safety protections.

•TEMPO is the FDA's first pilot program specifically designed to expand access to digital health devices for chronic disease management
•The voluntary initiative aims to balance increased patient access with maintaining safety protections and regulatory oversight
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Regulatory
•4 min read

FTC Blocks Edwards Lifesciences' $945M Heart Device Deal

The Federal Trade Commission filed suit to block Edwards Lifesciences' proposed $945 million acquisition of JenaValve Technology, alleging the deal would create a monopoly in the market for transcatheter aortic valve replacement devices used to treat aortic regurgitation. The FTC argues that combining the only two companies with ongoing U.S. clinical trials for these life-saving heart devices would stifle innovation and increase costs for patients.

•Edwards acquired JC Medical in July 2024 and seeks to buy JenaValve for $945 million, combining the only two companies with ongoing U.S. clinical trials for TAVR-AR devices
•More than 8 million Americans suffer from aortic regurgitation, currently treatable only through invasive open heart surgery
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