Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the fourth from the company and its partners to notch breakthrough status. Read More
Corwave SA raised €26 million (US$28 million) in the second close of its series C funding round taking the total amount to €61 million. The funds will go toward the industrial development of the company’s facilities as well as entry into clinical trials for its heart pump, the Corwave LVAD, which is based on its wave membrane biomimetic technology, inspired by the undulating movement of marine animals. Read More
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas. Read More
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR. Read More
In a wise move from Owlet Inc.’s point of view, the U.S. FDA cleared the company’s Babysat pulse oximetry sock for infants. The wire-free sock design permits safe and comfortable medical-grade monitoring for infants who might otherwise require extended hospitalization. Read More
The U.K. Medicine and Healthcare Products Regulatory Agency (MHRA) has moved to incorporate the Global Medical Device Nomenclature (GMDN) system into its device registration database, a development that will ease the task of providing postmarket surveillance for these products. However, the change may also take some of the noise out of the registration process in the U.K. market, thanks to the standardization of information the GMDN represents. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bigfoot, Exact Sciences, Grail, Sequana. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocardia, Carmat, Intrinsic Therapeutics, Lightpoint Medical, Metavention, Quest, Seastar Medical, Shenzhen Insighters Medical Technology, Sight Sciences, Teleflex, Telix Pharmaceuticals, Vygon. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anumana, Lumira, Mediso, Qiagen. Read More
