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. Read More
Nanocube Health Ltd. is developing accessible, low-cost nanorobots that could revolutionize diagnosis and treatment of hard-to-diagnose cancers, with pancreatic cancer being the initial focus. Read More
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. Read More
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. Read More
Researchers from Case Western Reserve University and the U.S. Department of Veterans Affairs, continue their development of a neuroprosthetic which comprises a system of implanted or wearable sensors. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Fujifilm, Imac, Karl Storz, Lifelabs, Obvius Robotics, Quest Diagnostics Completes, Sonde Health. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Resivant Medical, Surgentec, Vericel. Read More
