The U.S. FDA granted de novo authorization for Signifier Medical Technologies LLC’s ExciteOSA, the first treatment for mild obstructive sleep apnea and snoring designed for daytime use. Used for 20 minutes a day, the device improves the function of the tongue muscle to prevent airway obstruction while sleeping. ExciteOSA, previously called Snoozeal, already has a CE mark. Read More
Zimmer Biomet Holdings Inc. continued its transformation, disclosing Friday that it will spin off its spine and dental businesses into a separate, publicly traded company. The move will enable the independent company, identified as Newco, to pursue strategies and growth in spine and dental solutions that have not been a major focus for Zimmer Biomet, while allowing the latter to focus on high-growth orthopedic segments. Read More
The Biden administration said it will use the U.S. Defense Production Act to grapple with the COVID-19 pandemic in a plan that includes a large increase in vaccine purchases. Also on tap is an increase in production of at-home test by six companies in addition to Ellume Ltd., of Perth, Australia, which will ship more than 8 million of their tests to the U.S. by the end of the year. Read More
Hologic Inc. is teaming up with Google Cloud to use machine learning technologies to improve the accuracy and timeliness of cytology for cervical cancer screening. Marlborough, Mass.-based Hologic, which makes both Pap and human papillomavirus (HPV) assays, is already using artificial intelligence (AI) and machine learning in its new digital cytology platform that is available in Europe. The multiyear collaboration with Mountain View, Calif.-based Google Cloud will start with innovating that product further by enhancing the deep learning component of the system. Read More
Suzhou Basecare Medical Corp. Ltd., a genetic test developer for assisted reproduction, raised HK$1.82 billion (US$235 million) in an initial public offering on the Hong Kong Stock Exchange on Feb. 8, with shares opening nearly 10% higher. The IPO will support the company to continue to develop pre-implantation genetic (PGT) testing products for assisted reproduction. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cognivue. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: DoJ settles with alleged DME fraudster; GAO: Veteran’s community centers had issues before pandemic. Read More
Keeping you up to date on recent developments in cardiology, including: Radial access shows well in analysis of PCI data; ACC, SVS combine registries; VAD-associated ED visits down, but room for improvement. Read More
