The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) issued draft guidance Tuesday to support clinical testing of high-intensity ultrasound systems for ...
Industry trade associations made the case for revisions to draft guidance on clinical testing recommendations for prostate tissue ablation devices in comments earlier this month. The Medical Imaging & ...
Less than a week after making a regulatory submission for a $1 million capital raise, prostate health company ProUroCare Medical, based in Eden Prairie, Minnesota, announced that it has secured market ...
SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug ...
OncoAssure Ltd, an Irish medical diagnostic company, announced the publication of new data in the journal BJUI Compass that demonstrate the clinical validation of OncoAssure Prostate, a novel biopsy ...
Francis Medical’s Vanquish device for treating intermediate-risk prostate cancer has been cleared by the US Food and Drug Administration (FDA). Vanquish is a transurethral, ultrasound and ...
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