In another boost to its diabetes portfolio, Medtronic plc was granted CE mark approval for its Simplera continuous glucose monitor (CGM) sensor. The EU greenlight for Simplera follows the U.S. FDA approval for Medronic’s Minimed 780G insulin pump system earlier in the year. Simplera is an all-in-one disposable CGM sensor which features a two-step insertion process and will help patients who must have multiple daily injections (MDI) manage their diabetes.
Medtech Europe has on several occasions given voice to concerns about the drawn-out overhaul of the European Union’s medical device regulation but has come up with a new set of recommendations to break the regulatory logjam.
The U.S. FDA’s Sept. 6 hearing of the Patient Engagement Advisory Committee (PEAC) tackled the question of health equity, a discussion that touched on several issues such as accessibility. One of the committee’s recommendations was that the FDA assist the Centers for Medicare & Medicaid Services (CMS) with the latter’s task of developing codes for payment, not the kind of task to which the FDA is typically assigned.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exactech, Tyber Medical.
Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic, Microvention.
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
The U.S. FDA is going straight to final guidance with its “Considerations for the conduct of clinical trials of medical products during major disruptions due to disasters and public health emergencies [PHEs].”
The U.S. FDA is still sorting through the feedback for its proposal to modestly align the Quality System Regulation with ISO 13485, but the agency has posted a draft four-year plan for regulatory harmonization that is substantially broader in scope than just quality management system considerations. While this proposal addresses a significant need for device makers working in multiple markets, the objectives include an assessment of at least nine non-FDA harmonization proposals by the end of fiscal year 2025, a clear indicator that harmonization will continue to be every bit the slog it has proven to be in recent years.
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