President Donald Trump’s penchant for tariffs as a negotiating tool was on full display when he slapped a 25% tariff on products coming from Mexico and Canada – which may already been suspended in the case of Mexico. The actual impact of the tariffs on med tech is nonetheless tough to gauge due in no small part to the prospect that manufacturers will simply pass on at least part of the tariff to its customers in the U.S.
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.
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