FDA Grants De Novo Clearance for INVOcell
The FDA has granted Medford, Mass.-based INVO Bioscience’s de novo request for its INVOcell system for the incubation of eggs and sperm during fertilization and early embryonic development. The device produced pregnancy rates equivalent to traditional in vitro fertilization treatments in clinical studies, the company says. Benefits include a more natural and stable vaginal incubation than in a conventional IVF incubator, a reduced risk of incorrect embryo transfers, a lower cost of infertility treatments and increasing geographic accessibility.
China Approves Avedro’s KXL System
China’s FDA has approved Massachusetts-based Avedro’s KXL System, making it the first company to receive approval from the country’s regulatory body for a corneal cross-linking device. The procedure combines riboflavin ophthalmic solution with UVA irradiation from the KXL device and is indicated to treat keratoconus and post-LASIK ectasia, both of which are progressive, sight-threatening conditions.
Brazil Green Lights Jazz Band Platform
Brazil’s ANVISA has approved Implanet’s Jazz Band spinal implant platform. The company’s commercial partner, Importek, says it plans to perform the first Jazz surgeries in the coming weeks. France-based Implanet received expanded 510(k) clearance from the FDA in September to use Jazz with 100 percent of thoraco-lumbar fixation systems ().
FDA OKs Cerapedics’ PMA for i-FACTOR
The FDA has approved Colorado-based Cerapedics’ premarket approval application for i-FACTOR peptide enhanced bone graft for use in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. i-FACTOR is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine.
Omnicell to Acquire Aesynt for $275 Million
Mountain View, Calif.-based Omnicell has reached an agreement to acquire Aesynt, a medication management company, for about $275 million. The acquisition will broaden the Omnicell’s existing portfolio with Aesynt’s IV solutions, central pharmacy solutions, point of care solutions and enterprise software. Specific products from Aesynt include IV preparation analytics, unit dose medication dispensing robots, medication storage and dispensing cabinets for nursing units and operating rooms, and medication logistics management software. The transaction is expected to close in 2016.
Health Canada Approves Anika’s Cingal
Anika Therapeutics has received Health Canada approval for its Cingal medical device to treat pain associated with osteoarthritis of the knee. Cingal is a combination viscosupplement formulated with the company’s cross-linked sodium hyaluronate and triamcinolone hexacetonide, an FDA-approved steroid to treat inflammation. Osteoarthritis is the most common joint disease in the world, affecting more than 5 percent of the global population, the Bedford, Mass.-based company says. Cingal is Anika’s third-generation viscosupplementation product.