Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Tau Medical, Bios Health, Myndspan, Surmodics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioretec, Essilorluxottica, Roche.
Concluding a two-year journey, Baxter International Inc.’s kidney care unit finally separated from the company and started a new life as Vantive, following the closing on Jan. 31 of its $3.8 billion sale to the Carlyle Group Inc.
The EU’s Medical Device Coordination Group issued a guidance on the types of products that qualify as in vitro diagnostics (IVDs), including some important distinctions even in instances in which a given analyte is the subject of two tests.
Tensive S.r.l. raised €14 million (US$14.5 million) in a series A financing round for its bio-absorbable breast implant Regenera, for patients undergoing reconstructive surgery after lumpectomy. The funds will be used to complete a pivotal clinical trial to evaluate the safety and performance of the technology.
Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed.
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