The latest global regulatory news, changes and updates affecting medical devices and technologies, including: MHRA lists premarket requirements; OIG says up-coding may be driving more expensive admissions; TGA tees up Haimex; White House calls for 100-day review for supply chain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biobarica, Debx Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: American Cryostem, Assure Holdings, Biotherapeutic Labs, Bird & Cronin, Caredx, Cerus, Charles River Laboratories, Clinical Reference Laboratory, Co-Diagnostics, Collplant Biotechnologies, Dynatronics, Grin, Henry Schein, Icon, Illumina, Imaging Endpoints, Intalere, Kibur Medical, Neovasc, New England Biolabs, Oxford Nanopore Technologies, Patientslikeme, PRA Health Sciences, Protembis, Puretech Health, Renalytix AI, Rubiconmd, Sentry Neuromonitoring, Shandong Zhongbaokang Medical Implements, Siren Care, Smiledirectclub, SQN Clinical, Transchart, TX Services, United Therapeutics, Veristat, Walgreens.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aquestive, Bluebird, Cansino, Exelixis, Gannex, J&J, Retrotope, RDIF, Sinopharm, Viiv.