Clinical updates, including trial initiations, enrollment status and data readouts and publications: Elutia, Materna, Immunexpress, Real Heart, Wat Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme, Accustem Sciences, Bioaffinity , Chrome Holding, Carolina Molecular, Cortigent, Emeritus, Exero Medical, Hyperflex, Isto Biologics, Labconnect, Lemonaid Health, Renalytix, SS Innovations, Team Technologies, Tempus AI, Vivani.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amber Impants, Roche.
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
On the heels of the announcement of German bionics developer Ottobock SE KGaA's pending IPO and more than 20 med-tech IPOs completed to date in 2025, four other med-tech companies spanning three continents queued up to go public on four exchanges, potentially signaling an active fall for med techs worldwide.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.
Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.
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