Virtually all regulatory systems present at least some ambiguity as to the respective regulatory status of software when installed in hardware for medical purposes, and the European Commission’s (EC’s) Medical Device Coordination Group (MDCG) has attempted to provide clarity on these questions.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Concordance Medical, Edwards Lifesciences, Enterra Medical, Eosolutions, Jinghao Medical.
Bioxcel Therapeutics Inc. said a third-party audit of data from its Tranquility II phase III study came back clean, potentially positioning the firm to submit the statistically significant results in a supplemental NDA seeking approval of BXCL-501 in treating agitation associated with dementia in probable Alzheimer’s disease.
Four other companies want to replicate Biomarin Pharmaceuticals Inc.’s recent success as they seek approvals to treat the rare but most prevalent genetic form of dwarfism, achondroplasia. The U.S. FDA approved the sNDA for injectable Voxzogo (vosoritide), fibroblast growth factor receptor 3 (FGFR3) inhibitor from Biomarin on Oct. 20.
The U.S. Environmental Protection Agency (EPA) has struggled to devise a final rule regarding regulation of ethylene oxide (EtO) after several years, a regulatory activity that has device makers concerned about domestic capacity for sterilization.
Ventric Health Inc. received U.S. FDA 510(k) clearance for its Vivio system, a mobile, non-invasive medical device that can aid in the diagnosis of heart failure. With early diagnosis crucial for treating and managing the condition, Vivio uses advanced algorithms to detect elevated left ventricular end diastolic pressure (LVEDP) in less than five minutes and can therefore improve clinical and health outcomes.
After nearly two years with an unconfirmed acting director at its helm, the U.S. NIH is one step closer to finally having Senate-confirmed leadership to steer the agency in a time pressed with political agendas, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 Oct. 25 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director.
Vuno Inc. gained a U.S. FDA’s 510(k) clearance for its artificial intelligence (AI)-powered brain quantification device, Vuno Med-Deepbrain, to diagnose possible dementia in patients “even before mild cognitive impairment.”
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, RF Medical, Ventric Health.
Bloomsbury Genetic Therapies Ltd. has announced it received orphan drug designations from the FDA and the European Commission for BGT-INAD, an investigational gene therapy for the treatment of infantile neuroaxonal dystrophy (INAD).
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