After years of aggressive acquisitions, Medtronic plc joined 3M Co., General Electric Co. and Johnson & Johnson in rationalizing its business by splitting into more focused enterprises. Medtronic will separate its patient monitoring and respiratory therapy groups into a new company with projected annual revenue of $2.2 billion and 8,000 employees in the next 12 to 18 months, assuming regulatory and final board approvals. Read More
The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development. Read More
Synaptive Medical Inc. has introduced a free water correction feature to its Modus Plan software to restore tracts in areas surrounding brain lesions affected by edema and which interferes with automated mapping of the brain. Water from edema obscures retrieval of diffusion tensor imaging (DTI) data and tractography mapping used to evaluate white matter pathways in the brain. Read More
Nousq Pte Ltd. has been declared the winner of the 2022 Asia Pacific Accelerator program with its pediatric ear tube insertion device. Singapore-based Nousq’s victory was determined by a live audience vote on during the Medtech Innovator Asia Pacific 2022 Grand Finals, organized by medical device accelerator Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed). Read More
At the Saturday, Oct. 22 session, ‘Basic Science: Correlates of protection, immune response and the host-microbe interaction,’ of the IDWeek 2022 infectious disease conference, moderator Luiz Bermudez, professor at Oregon State University, introduced the latest advances to prevent infections with Treponema pallidum during neurosyphilis (NS), Staphylococcus aureus and osteomyelitis, and Mycobacterium tuberculosis during influenza. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Exact Sciences, Pear Therapeutics, Veracyte, Viewray. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Chronwell, Echosens, GE Healthcare, Genesys, Lunit, Thubrikar. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance. Read More
