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.
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.
New hires and promotions in the med-tech industry, including: Brain.Q, Establishment Lab Holdings, Microbot Medical, Scientia Vascular, Symbio, Tactile Systems, Vaso Corp.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Angiodynamics, Bayer, Personalis, Samsara Vision, WAT Med.
Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.
Glooko Inc. and Hedia ApS launched an integrated software solution in the U.K. to support people with diabetes who require advanced doses of bolus insulin. The solution combines Glooko’s diabetes monitoring platform with Hedia’s diabetes dosing recommendation app to deliver personalized insulin dosing advice to people with type 1 and type 2 diabetes.
Brainaurora Medical Technology Ltd. debuted on the Hong Kong stock exchange Jan. 8 with a HK$583.18 million (US$74.93 million) IPO, offering about 181.11 million shares at HK$3.22 per share.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Rad Laboratories, Danaher, Emervax, Kindeva, Medmira, Thermo Fisher.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Injectables, Capsovision, J&J, Qiagen, Revvity.