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.

Shares of Chinese and South Korean med-tech companies continued to rise after the World Health Organization declared mpox a public health emergency of international concern Aug. 14 after recent outbreaks.

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.

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.

Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.

The U.S. CMS said its Medicare administrative contractors withdrew a draft local coverage determination that would have restricted the use of surveillance testing for allograft rejection.

TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.