Medtronic plc secured CE mark approval under the EU Medical Device Regulation for its Brainsense adaptive deep brain stimulation system. The technology represents a major advancement in the treatment of Parkinson’s disease as it provides real-time, self-adjusting brain stimulation based on the patient’s brain activity, offering a more personalized therapy. Read More
The U.S. FDA’s Accreditation Scheme for Conformity Assessment (ASCA) program has its benefits, but industry had some sharp words for the agency in commenting on the 2024 ASCA draft guidance. The Advanced Medical Technology Association stated that FDA reviewers asked for full conformity test results for roughly 5% of premarket applications, a rate seen as excessive given the program’s design. Read More
Quanterix Corp. plans to merge with Akoya Biosciences Inc., in an all-stock transaction that both companies hope will bolster their fortunes. The transaction will create an integrated solution for ultra-sensitive detection of blood- and tissue-based protein biomarkers. Read More
The U.S. FDA posted a draft guidance that would revisit a 2014 final guidance on sex-specific data drawn from medical device clinical trials, expanding the scope to include considerations of gender. Read More
In the first patenting to emerge from Carlsbad, Calif.-based Biologic Input Output Systems Inc., its chief development officer, Timothy Miller, collaborated with academics on the development of implantable neural interfaces for placement in the peripheral nervous system. Read More
New hires and promotions in the med-tech industry, including: Brain.Q, Establishment Lab Holdings, Microbot Medical, Scientia Vascular, Symbio, Tactile Systems, Vaso Corp. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angiodynamics, Bayer, Personalis, Samsara Vision, WAT Med. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Becton, Dickinson and Co, Clarity, Clinic Barcelona, Element Biosciences, Helix, Human Longevity, Illumina , Komodo Health, Neurosigma, Nowdiagnostics, Piccolo Medical, R3 Vascular, Reveal Genomics, Revvity, Seastar, Sleepscore, Spectrum Vascular, SS Innovations. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain.q, Exagen, Imvaria, Medtronic, Q'Apel, Roche, Spear Bio, Werfen, Gore. Read More
