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.
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.
Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.
Vision Care Group CEO Masayo Takahashi led the world's first clinical study of a retinal cell transplant derived from induced pluripotent stem cells (iPS cells) in 2014 when she led the Laboratory for Retinal Regeneration at Japan’s Riken Center for Biosystems Dynamics Research. In 2019, she founded Vision Care and subsequently founded two subsidiary companies dedicated to developing cell and gene therapies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Orano Med, Radiomedix, Samsung Electronics, T2 Biosystems.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ascensia, Binx, Cardinal Health, Emed, Imaware, Link, Science 37, Sensome, Think Surgical.