MedyMatch Technology’s intracranial hemorrhage detection software has landed a spot on the FDA’s expedited access pathway (EAP). The designation sets MedyMatch up to receive advice from the FDA as it ...

The U.S. Food and Drug Administration (FDA) has issued 510(k) marketing clearance for MIM Software's Mobile MIM application, the first mobile image viewing application to receive clearance for ...

Please provide your email address to receive an email when new articles are posted on . The FDA granted 510(k) clearance to a new image-guided system for use during interventional CV procedures. The ...

MinnPost’s journalists are out in the community to report on the things that are happening in Minnesota. Your support right now will help fund their work AND keep our news paywall-free. The Food and ...

Aug. 15 (UPI) --The Food and Drug Administration on Thursday proposed manufacturers put graphic images and text warning labels on cigarette packs that show the health risks of smoking. The images ...

The Food and Drug Administration on Thursday proposed long-delayed graphic health warnings for cigarette packages, taking a step toward fulfilling a requirement of a decade-old smoking prevention law.

The FDA has given the OK to digital health startup Nephosity to market its image viewing mobile app for diagnostic purposes. Nephosity said it receive 510(k) clearance for use of its app in situations ...

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified ...

Please provide your email address to receive an email when new articles are posted on . The FDA has issued a proposed rule that would require cigarette packaging and advertisements to include new ...