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 long struggle by Boston-based I2o Therapeutics Inc.’s business unit Intarcia Therapeutics to get long-lasting exenatide for diabetes onto the market ended with a final thumbs-down from the U.S. FDA because of safety concerns. At issue was ITCA-650, a twice-yearly implantable exenatide-device combo meant to improve glycemic control in adults with type 2 diabetes.

The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.

The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.

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.