The road to getting these devices from concept to patient use is filled with meticulous checks to ensure safety, efficacy, and compliance with regulatory standards. Central to this journey is the ...

Here's the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical ...

Henderson, PhD, professor at the UNC Department of Social Medicine, led a thorough analysis of clinical validation data for ...

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

OncoAssure Ltd, an Irish medical diagnostic company ... International Compass (BJUI Compass), which demonstrates the clinical validation of OncoAssure Prostate, a novel biopsy test which provides ...

Sound Blade Medical, Inc., a medical device company developing handheld ultrasound-guided histotripsy technology, announced today the successful closing of an oversubscribed US $16.5 million Series A ...