Body: The U.K.’s Medicines and Health Care Products Regulatory Agency (MHRA) has a program designed to facilitate more rapid market access for medical devices of urgent need, and now the agency has put money into the policy.
The Versavue single-use flexible cystoscope, recently launched by Boston Scientific Corp. in the U.S., could help reduce the risk of infections in patients that comes from the improper reprocessing of reusable cystoscopes, Ron Morton, Boston Scientific chief medical officer, Urology told BioWorld.
Just in time for Valentine’s Day, the circulatory system devices panel of the medical devices advisory committee for the U.S. FDA showed some love for Abbott Laboratories’ Triclip transcatheter edge-to edge repair (TEER) system for leaky tricuspid heart valves.
New York-based Viewmind Inc. has applied for patent protection of methods and systems for detecting neurological disorders and/or measuring, fine-motor skills, processing speed, decision making, and cognitive processes by measuring eye movements, oculomotor features and pupil behavior.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bone Solutions, Tyber Medical, Wandercraft.
The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.
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