The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts advisory for respiratory splitters; NICE: Propel device not ready for routine use; MITA sounds off on third parties with white paper; Ethicon, AIM settle on Esutures sales.

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ava, Bactiguard, Nyxoah, Soundbite Medical.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beyond Medical Technologies, Biodesix, Biotelemetry, Canary Health Technologies, Foxsemicon Integrated Technologies, GE Healthcare, Kayan Health, Predictiv Care, Prophase Labs, Royal Philips, Smartbreast, SyntheticMR, Tissium, Trisalus, United Imaging, Zavation Medical Products.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biodesix, Foundation Medicine, Medtronic.

Med-tech firms raising money in public or private financings, including: Cleveland Diagnostics, Opgen, Rubix, Sientra, Titan Medical.

New hires and promotions in the med-tech industry, including: 908 Devices, Apollo Medical, Behavr, Cecilia Health, Covanos, Echosens, Intershunt, One Drop, Personalis, Seniorlink, Vault Health.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Astrazeneca, Bausch Health, Brainstorm Cell, BMS, China Oncology Focus, Edding, Immunomet, Navidea, RDIF, Sorrento, Triastek.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Amicus, BMS, Brooklyn Immunotherapeutics, Cardior, Curis, Cyclo, Evolve, Exelixis, Heat, Innate, Innovent, Ipsen, Janssen, Kalvista, Medigene, Melt, Neurorx, Opiant, Orchard, Paxmedica, Regenxbio, Sumitomo, Taiga, Trefoil, Turn.

Biopharmas raising money in public or private financings, including: Adagene, Autolus, Baudax, Cambrian, Drug Farm, Enveric, Genprex, Geovax, Ibere, Immunomet, Neox, Neurophth, Opgen, Revolution, Sana, Scopus, Seraxis, Tyme.

New hires and promotions in the biopharma industry, including: Antev, Aquestive, Caribou, Eli Lilly, Equillium, Gemini, Ironwood, Metrion, Novocure, Werewolf.