The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
The U.S. Court of Appeals for the Federal Circuit occasionally remands a patent litigation case to district court for a variety of reasons, as seen in a decision involving Trudell Medical and D R Burton.
The U.K. Medicines and Health Care Products Regulatory Agency reported a pilot program for the use of RWE in regulatory decision making, which is largely directed toward drug products.
The European Commission’s proposal for an AI-specific liability law seemed destined to pile onto existing EU liability law, but the commission reported it will pull the legislative proposal dubbed the AI Liability Directive.
The European Commission issued a set of guidelines for the use of AI as a supplement to the EU’s Artificial Intelligence Act, a document of which chatbot developers will want to take note.
The U.K.’s National Institute for Health and Care Excellence (NICE) historically relies on cost savings to vet novel medical technologies, but that may soon change per a Feb. 7 announcement.
The U.S. national coverage analysis for transcatheter tricuspid valve replacement drew support from cardiologists and device makers alike, but the Medical Device Manufacturers Association is urging CMS to plan ahead in its final coverage memo and consider the coverage needs outside the confines of the existing U.S. FDA-approved device.
The med tech patent wars conscripted another two companies via a patent infringement lawsuit between Inari Medical Inc. and Imperative Care Inc. — a struggle that is playing out in a California district court.
The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.
