Shoulder Innovations Inc. (SI) reported closing of an oversubscribed $42 million series D financing to further advance commercialization and distribution of its integrated Inset system. In addition to functions performed by SI’s humeral short stem, reverse and stemless components the new implant has proven its ability to overcome loosening of the glenoid, one the most challenging procedures to perform during arthroplasty.
Ciliatech SAS reported positive news for people suffering from glaucoma who want to avoid the complications that come with using existing glaucoma procedures. Results from the SAFARI 1 clinical trial, using its first-generation cilio-scleral inter-positioning device (CID) implant in patients with open angle glaucoma, showed marked stability of intraocular pressure (IOP), along with a significantly reduced need for glaucoma medication 24 months on from surgery.
Developers of artificial intelligence (AI) and machine learning (ML) algorithms have found themselves returning repeatedly to the U.S. FDA for seemingly modest updates to their products, a problem that may soon be relieved by an FDA draft guidance on predetermined change control for AI and ML. However, Brad Thompson of Epstein, Becker & Green, P.C., told BioWorld that the terms of the draft “hugely increases the burden on developers to plan ahead” in order to obtain that postmarket relief from repeated 510(k) filings, a concession that device manufacturers and software developers may be more than willing to make.
Histosonics Inc., the developer of a non-invasive platform that uses sonic beams to destroy tissue, treated the first patient in its phase I study of the procedure as a treatment for kidney tumors at the Leeds Teaching Hospitals National Health Services Trust in the U.K.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Aevice Health, Bioretec.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ad Astra Diagnostics, Bigfoot Biomedical, FVRS, Fundamentalvr, Haply, Illumina, Sonex, Stilla.
RSS
