Shanghai Sanyou Medical Co. Ltd. will be working with Implanet SA to get the latter’s Jazz platform for treating spinal pathologies approved and distributed in China. “Through this partnership, Sanyou Medical will be Jazz’s exclusive distributor. We are currently working on obtaining registration in China with the authorities. We will have a better view on the commercial launch timing later this year,” Ludovic Lastennet, CEO and founder of Implanet, told BioWorld.
Volpara Health Technologies Ltd. joined forces with Microsoft Corp. to accelerate the research and development of software that uses mammograms to identify potential cardiovascular issues.
Orthocell Ltd. landed its first global licensing deal for its regenerative collagen medical device with Biohorizons Inc., one of the largest dental implant companies in the world. The licensing deal comes on the heels of the Perth, Australia-based company reporting final data from its nerve reconstruction study that showed patients continued to improve between 12- and 24-months post-treatment with its regenerative nerve repair device Remplir.
Peijia Medical Ltd. has received two marketing approvals from China’s NMPA for its catheters to be used in neurointerventional surgery. They are the balloon guide catheter (BGC) Fluxcap and delivery balloon dilation catheter Fastunnel. Both were developed by Peijia’s wholly owned subsidiary Achieva Medical Ltd.
Mega Genomics Ltd. raised HK$153.4 million (US$20 million) in an initial public offering on the Stock Exchange of Hong Kong. Its shares jumped 16.7% in the middle of the first trading day on June 22 and closed at HK$18 a share. Beijing-based Mega Genomics plans to allocate 30% of the proceeds to the sales, marketing, and commercialization of its consumer genetic testing and cancer screening services and products.
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.
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