The U.S. Patent and Trademark Office (USPTO) published new enablement guidelines Jan. 10 to provide more consistency across technologies to ensure patent applications truly enable the breadth of their claims in keeping with the Supreme Court’s unanimous decision last year in Amgen Inc. v. Sanofi SA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Darmiyan, Inkspace Imaging, Neuralace, Pursuant Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Clinchoice, CSI Medical, Extremity Medical, Henry Schein.
In what represents the first patenting from Immersive Reality Group LLC, the company’s co-founders describe their Intellighealth system for detecting the early onset of respiratory diseases using artificial intelligence and wearable remote health monitoring technologies.
Sichuan Jinjiang Electronic Medical Device Technology Co. Ltd. received approval from China’s National Medical Products Administration (NMPA) approval for the commercial use of its PFA technology in the treatment of atrial fibrillation, making it the first pulsed field ablation device to gain approval in the country.
The ongoing controversy over the use of ethylene oxide (EtO) as a medical device sterilant has yielded a certification by the U.S. FDA for hydrogen peroxide as an alternative category A sterilant. The news is a welcome bit of relief for industry and for patients as the Environmental Protection Agency still seems bent on imposing what some in industry see as draconian controls on EtO, which is still employed to sterilize half of all medical devices used in the U.S. each year.
Medtronic plc received the greenlight from the U.S. FDA for its latest deep brain stimulation system, the Percept RC. The rechargeable neurostimulator includes the company’s sensing technology which captures data from brain signals and allows for more personalized therapy.
RSS
