Building Confidence in Clinical Trial Data and Technology Processes
Applied Clinical Trials Online Clinical trials are growing more complex, and this trend will increase. Sponsors now expect seamless data capture from electronic systems, labs, wearables, patient-reported outcomes, and third-party sources, all feeding pivotal datasets. As data sources become more diverse and voluminous, the risk of integration and process errors rises. Small oversights in data […]
read more
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 […]
read more
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 […]
read more
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 […]
read more