The agenda for the U.S. FDA’s Sept. 8-9 advisory hearing includes a proposed down-classification of bone growth stimulator (BGS) devices to class II, but while the proposal met some resistance from an industry group, the panel sided with the FDA and declared BGS units ready for prime time as 510(k) devices. Read More

Israeli startup Envizion Medical Ltd. said it is partnering with one of the largest private U.S. hospital chains to deploy its electromagnetic fields-guided feeding tube placement navigation technology in 150 hospitals nationwide. The company received U.S. FDA 510(k) clearance for the Envue navigation device and Envizion feeding tubes in April 2019. Read More

New medical instruments with integrated soft electronics could improve diagnosis and treatment of cardiac conditions. The surgical tools use soft materials that conform to the body’s tissue and permit a single catheter to combine diagnostic and therapeutic functions while providing real-time feedback and electrophysiological information. Read More

PARIS – Novacyt SA has obtained CE marking approval for its polymerase chain reaction (PCR) respiratory virus test panel, Winterplex. Read More

HONG KONG – Singapore-based Genesis Medtech International Pte. Ltd. has acquired the Chocolate Touch drug-coated balloon angioplasty asset from Pleasanton, Calif.-based Trireme Medical LLC. The drug-device technology asset in question is designed with the intention of providing a safer and more effective treatment for patients suffering from peripheral vascular disease, compared to traditional balloon angioplasty. Read More

BioWorld's offices were closed in observance of Labor Day in the U.S. No issue was published Monday, Sept. 7. Read More

New hires and promotions in the med-tech industry, including: Assure Holdings, Bardy Diagnostics, Bruker, Davita, Dermtech, Medhub, Titan Medical. Read More

Med-tech firms raising money in public or private financings, including: Enable Injections, Nanospectra Biosciences. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Helius Medical Technologies. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acutus, Alkahest, Arches Research, Assure Holdings, Avacta, Cambus Medical, Co-Diagnostics, Confirm Biosciences, Cytosorbents, Diagnos, Diasorin, Fluidigm, Freudenberg Medical, Grifols, Inovio, Irhythm, Labcorp, Memed, Merit Medical, Neuronostics, Polarity TE, Qiagen, Roche Canada, Seegene, Thermo Fisher Scientific. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inspiremd, Roche, Theranica. Read More

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ocular Therapeutix. Read More

Keeping you up to date on recent developments in oncology, including: Algorithm improves prediction of hepatocellular carcinoma following hepatitis-driven cirrhosis; MTOR-targeting metabolite discovered; Dartmouth’s Thayer School wins NIH grant. Read More