The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.
A blood test developed by Datar Cancer Genetics Inc. for the detection of glial malignancies (GLI-M) could be a breakthrough for the diagnosis and treatment of brain cancer, according to a study published recently in the International Journal of Cancer.
The U.S. FDA added a second pulsed field ablation (PFA) system to the approved list with its greenlight for Boston Scientific Corp.’s Farapulse for treatment of atrial fibrillation (AF). Farapulse joins Medtronic plc’s Pulseselect, which garnered FDA approval in December. Two other PFA devices scored regulatory wins since the new year: Biosense Webster inc.’s Varipulse secured approval from the Japanese Ministry of Health Labor and Welfare and Sichaun Jinjiang Electronic Medical Device Technology Co. Ltd. got the nod from China’s National Medical Products Administration.
The biopharma industry lauded the first steps the Australian government has taken to widen access for drugs and devices via reforms to the current health technology assessment process that has remained unchanged for 30 years.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bruin Biometrics, Copan, Magstim, Nuvoair, Si-Bone, Tyber.
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