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.

Drug and device sponsors conducting clinical trials in China to support U.S. FDA approval may want to reconsider their choice of trial sites, as trials conducted at hospitals and clinics affiliated with China’s military or in the Xinjiang Uyghur Autonomous Region could be in for increased scrutiny.

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.

Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.

About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.

Vericel Corp.’s Maci for repairing cartilage defects in the knee has been approved by the U.S. FDA via a supplemental biologics license application. Using a patient’s own cells cultured on a porcine collagen membrane, Maci Arthro is delivered arthroscopically and allows for repair of knee cartilage defects up to 4 cm².