“First reported 32 years ago, it has still not been FDA-approved, because there was no push by industry to commercialize it or validate it clinically,” Alpan says. He and his colleagues have ...

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations. This webinar ...

The agency cited quality issues at facilities testing Dexcom’s G6 and G7 monitors, including inadequate validation and risk ...

Prescription digital therapeutics are clinically-validated, FDA-cleared software applications that demonstrate safety and efficacy in trials to improve patient outcomes. They are designed to ...

Furthermore, the researchers found that the latest draft guidance, published by the FDA in September 2023, does not clearly ...

"We have always provided a validated, research-backed solution for concussion assessment. Now, with FDA clearance for both balance and cognitive testing, Sway can claim the only comprehensive tool ...

This submission marked a critical milestone in the Company’s efforts to enter the U.S. market with its drug testing system in 2025. The Company's 510(k) submission included performance data and ...