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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Med-tech firms raising money in public or private financings, including: Apiject Systems, Harvard Apparatus Regenerative Technology, Work Medical Technology Group. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Atricure, Contipi, Eversana, Medtronic, Neuraxis, Pacemate, Sonovascular, Spectral AI. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Aesculap, Boston Scientific, Clearmind, Illumina, Insulet. Read More
