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. Read More
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. Read More
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. Read More
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. Read More
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers. Read More
New hires and promotions in the med-tech industry, including: Charles River Labs, Dexcom, Fotona, Guardant Health, Insulet, Lucid Diagnostics. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alcon, Bonesupport, Covalon, Medtronic, Shiratronics, Tandem Diabetes. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Biocartis, Body Vision Medical, Penumbra, Womed. Read More
