The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
China’s National Medical Products Administration (NMPA) approved Ocumension Therapeutics Ltd.’s and Eyepoint Pharmaceuticals Inc.’s drug-device combination product, Yutiq (fluocinolone acetonide intravitreal implant), for chronic non-infectious uveitis affecting the posterior segment of the eye.
Samsara Vision Inc. signed a deal with China’s Lansheng Medical Corp. (Myvision) to bring Samsara’s next-generation visual prosthetic devices to mainland China, Macau, the Hanain Province, and Hong Kong.
India’s regulators have made more moves in recent times as part of its larger and ongoing movement to regulate medical devices in its country. The Ministry of Health and Family Welfare has just finalized its regulations over the licenses of medical device manufacturers and suppliers.
Regenerative medicine company Orthocell Ltd. reported final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with regenerative nerve repair device Remplir.
AI-enabled drug discovery company Insilico Medicine Ltd. has raised $60 million in a series D round to support expansion of its pipeline. The Hong Kong and New York-based company will use the proceeds to support clinical testing of its lead asset, a potential treatment for idiopathic pulmonary fibrosis (IPF), as well as the advancement of its Pharma.AI platform.
Shenzhen Xzing Technology Co. Ltd. received marketing approval from China’s NMPA for its Endofresh disposable electronic colonoscope. The disposable colonoscope provides images with 1920 x 1080 pixels, which helps with diagnosis. It is equipped with auxiliary water and a lens-washing function to make sure of clear vision throughout endoscopy. It also allows users to insert endoscopic accessories at any bending angle no more than 210 degrees.
Shanghai Microport Medbot (Group) Co. Ltd. plans to list on the Shanghai Stock Exchange on the Sci-Tech Board to raise ¥2.8 billion (US$420 million) to progress its surgical robots. The funds raised from the IPO would go toward research and development of the surgical robots, manufacturing, marketing and academic promotion, as well as replenishing working capital. The company also plans shareholder dividend distribution plans within three years following the IPO listing.
Australia’s Therapeutic Goods Administration (TGA) has made a range of changes to its medical device regulations in recent years that have largely been driven by the need to keep pace with changing technologies, TGA head John Skerritt said during the Ausmedtech 2022 annual conference in Melbourne, Australia.
Otsuka Pharmaceutical Co. Ltd. and Ai-Brainscience Inc. signed an exclusive sales agreement for Japan that will see Otsuka market Ai-Brainscience’s eye-tracking application to test for cognitive function. The eye-tracking app, AiBS-01, could become the first dementia diagnosis application to receive regulatory approval in Japan. Ibaraki, Japan-based Ai-Brainscience (AiBS) is developing devices that use the eye-tracking based cognitive assessment test to detect early dementia beyond the conventional assessment methods performed by specialists.
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