FDA exempts more wearable, AI features from oversight
Medtech Dive FDA exempts more wearable, AI features from oversight In a pair of guidance documents, the regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight. By: Elise Reuter • Published Jan. 8, 2026 The Food and Drug Administration released two final guidance documents that would […]
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A Proud Moment for Telemedicine Technologies at EUCROF 26
During the EUCROF 2026 gala dinner in Amsterdam, in front of 300+ participants from the European clinical research ecosystem, the xShare project Open Call Awards for Clinical Research were officially presented. We are extremely proud that Telemedicine Technologies contributed to three complementary xShare Open Call projects (out of 10), all recognised for their quality, innovation […]
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FDA guidance eases wearables oversight. But experts have questions about what’s next.
Medtech Dive Amid a deregulatory push by the Trump administration, the Food and Drug Administration is scrutinizing its digital health policies. The agency suddenly issued a pair of guidances earlier this month, intended to clarify its approach to wellness devices and medical software. The updates reflect changes to the agency’s thinking about what counts as a wellness […]
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Harnessing RWE for Post-Pandemic Healthcare: Accelerating Drug Development with Real-World Data
Med City News The Covid-19 pandemic impacted virtually every industry, with healthcare arguably undergoing the most drastic transformation. Pre-pandemic, most of us never could’ve imagined routine doctor visits happening over telehealth, or a brand-new vaccine being developed, tested, and authorized for emergency use in under a year. The urgency of the pandemic forced medical scientists […]
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