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 receive breakthrough status.

TGA eyes mutual recognition with EU for in vitro diagnostics

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. Yasha Huang, director of Asia-Pacific regulatory policy for Roche Diagnostics, said recently that this harmonization effort is preparatory to a mutual recognition pathway between these two markets, which creates an additional incentive for test developers to gain market access in the EU as quickly as possible.

Corwave hauls €61M in series C fundraising

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 Corewave LVAD, which is based on its wave membrane biomimetic technology, inspired by the undulating movement of marine animals.

Avita’s Recell gains FDA greenlight for skin repigmentation in vitiligo

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. Earlier this month, the FDA granted premarket approval to Avita’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity.

Owlet hoots about clearance of pulse oximetry baby socks

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 hospitalization.

MHRA adopts device nomenclature system into device registration database

The U.K. Medicine and Healthcare Products Regulatory Agency 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.

Also in the news

Anumana, Bigfoot Biomedical, Biocardia, Carmat, Cormedix, Exact Sciences, Grail, Intrinsic, Isotopia Molecular Imaging, Letsgetchecked, Lightpoint Medical, Lumiradx, Marqmetrix, Mediso, Metavention, Polarean Imaging, Poseidon, Quantum-Si, Quest Diagnostics, Qiagen, Retrieve Medical, Seastar Medical, Sight Sciences, Teleflex, Telix, Thermo Fisher Scientific, Vygon