Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anumana, Lumira, Mediso, Qiagen.
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.
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.
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.
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.
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.
Bristol Meyers Squibb Co. (BMS) joined the Inflation Reduction Act (IRA) pile-on June 16, filing a third constitutional challenge to the U.S. Medicare drug price negotiations mandated in the law that was narrowly passed last year on a partisan vote.
Following the death of a patient, the U.S. FDA halted Arcellx Inc.’s phase II pivotal trial of its CAR T-cell therapy for relapsed or refractory multiple myeloma (MM), putting Gilead Sciences Inc., which in December made the risky decision to part with $225 million up front for rights to the immunotherapy, in likely turmoil.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: F2G, Freya, Iaso, Sirnaomics, SK.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow Design, Owlet, Surmodics, Zynex.
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