Cognitoss, a resorbable bone graft in development by Locate Bio Ltd., received U.S. FDA breakthrough device designation for treating chronic osteomyelitis, a progressive, inflammatory bone infection. The graft uses a new class of composite collagen product combined with a dual-phasic release of antibiotics to prevent reinfection.

TORONTO – Scan the literature on mental health technologies, and you’ll find treatment apps for everything from depression to addiction. What you won’t find, said Claude Hariton, vice president and chief scientific officer at Quebec City-based Diamentis Inc., are tools to diagnose mental diseases. It’s a gap the company hopes to fill with Retinal Signal Processing and Analysis (RSPA), a tool just accepted into the U.S. FDA’s breakthrough devices program that diagnoses mental diseases from retinal signals in the eye.

Ultromics Ltd. received U.S. FDA 510(k) clearance for its artificial intelligence-driven decision support tool for the diagnosis of coronary artery disease (CAD). Used in conjunction with a clinician's assessment, Echogo Pro's algorithms improve disease prediction and support more accurate diagnosis. Echogo Pro is a stress-Echo module in the Oxford, U.K.-based company's Echogo suite for CAD diagnosis.

Computer system validation (CSV) has been the source of considerable drag on device makers’ efforts to realize value derived from investments in the company’s technology base, but this long-standing issue is finally drawing some much-needed attention.