FDA has approved EnteroMedics Inc.’s Maestro Rechargeable System, a pacemaker-like device used to help obese patients control hunger cravings.
FDA Weighs Patients' Risk Tolerance in Approving Obesity Device
The agency approved EnteroMedics’ Maestro neuromodulator to treat obesity despite the device not meeting endpoints in its pivotal trial. The agency relied in part on a survey that found obese patients willing to take more risks in exchange for weight loss.
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.