The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...

The Central Drugs Standard Control Organisation (CDSCO) has announced risk classification of 187 medical devices pertaining to interventional radiology under Medical Devices Software, under the ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...

The UK government has launched a consultation to gather views on the imminent updates of the current regulatory regime for medical devices, which include the application of technologies such as ...

Following the identification of several key challenges in the application of the Medical Device Regulation (MDR) and In Vitro Diagnostic ...

The Association of Personal Injury Lawyers (APIL) has renewed calls for a national register of medical devices to help prevent future health scandals such as the pelvic mesh crisis. The group said the ...

DALLAS, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster ...