On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) ...
The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...
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FDA announces regulatory exemptions for ‘non-medical grade’ devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
TRACY, Calif. -- When using highly complex medical devices, proper calibration ensures U.S. Army medical personnel can quickly treat battlefield casualties and get Soldiers back into the fight. In ...
In a significant move aimed at strengthening regulatory clarity for cancer related medical technologies, the Central Drugs ...
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