Grail Inc.’s multi-cancer early detection test, Galleri, preferentially screens for aggressive prostate cancer, addressing concerns about overdiagnosis and subsequent overtreatment of indolent cancers, a study published in JCO Precision Oncology demonstrated.

The U.S. Congress is examining legislative language to address what some believe is a deteriorating state of jurisprudence for injunction when infringement is found in patent litigation.

As of this week, consumers can order Dexcom Inc.’s Stelo continuous glucose monitor (CGM) online without a prescription, making it the first to hit the market. Dexcom will have competition soon, however, with Abbott Laboratories planning to roll out its over-the-counter Lingo and Libre Rio CGMs in short order.

The U.S. FDA caught up with four makers of CPAP cleaning machines in the form of warning letters advising the manufacturers that the claims made for their systems fall under the definition of a regulated medical device. In two of these warning letters, the FDA said it had been in touch with the manufacturer for at least two years, indicating that the agency has been steadily working on enforcement activities in this space for some time.

While product liability litigation in the U.S. for medical devices is a matter of state law, a legal theory from 1965 seemed to hint at a uniform national standard on strict liability for medical devices.

Since the U.S. FDA’s approval of the first pulsed field ablation (PFA) system in the U.S. last December, PFA technology has rapidly reconfigured the electrophysiology market in the U.S. and ramped up sales of PFA systems in Europe.

A magistrate judge for a U.S. district court has recommend that Abbott Laboratories receive $54 million in damages for third-party diversion of glucose test strips into the U.S. from other nations.

The clearance by the U.S. FDA of Healthccsng V2.0, an artificial intelligence cardiac solution developed by Nano-x Imaging Ltd.’s (Nanox) subsidiary, Nanox.AI, is highly “significant” for the company and will offer “substantial” benefits to cardiology departments by significantly enhancing the detection of coronary artery calcification, Erez Meltzer, Nanox CEO told BioWorld.

The U.S. FDA recently announced that Inari Medical Inc. issued a recall that corrects the instructions for use for roughly 2,500 units of the Clottriever XL catheter due to reports of device entrapment in the lung.

Additive manufacturing at the point-of-care (POC) might seem to open the world of medical device litigation to new theories of liability, but that isn’t likely in part because hospitals are wary of assuming the elevated legal risk associated with taking ownership of POC manufacturing activities.