The U.S. FDA’s rule for over-the-counter (OTC) hearing aids was several years late coming out, but the rule has nonetheless proven controversial from the outset. Two members of the U.S. Senate have blasted device makers for what they allege is interference with the rulemaking process via “astroturf” campaigns to prod hearing aid users to influence the agency’s final rule.
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.
Calyxo Inc. cleaned up with a $32.7 million series C financing round to support further development of the Cvac system for kidney stones. Questa Capital and CRG led the round, which brought the company’s total funds raised to $47.2 million.
Ganymed Robotics SAS raised a €21 million (US$21.2 million) series B round to develop its robotic system for total knee arthroplasty (TKA). Health care fund Cathay Health led the round, with participation from Credit Mutuel Innovation, Kurma Partners, BNP Paribas Developpement, and individual surgeons. The funds will be used to finalize development of Ganymed’s TKA surgical assistant and support the company’s expansion in France and the U.S.
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empowered Diagnostics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Dexcom, Electrocore, Laseroptek, Medial Earlysign, Reflexion, Roche, Zillion.
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