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.

The U.S. FDA is actively working on guidance for conversion of emergency use authorizations (EUAs) to conventional premarket review programs, but the FDA’s Tim Stenzel said he does “not perceive a need to rush to convert EUAs” because of the volume of EUA applications, and because he does not expect the public health emergency “to end anytime soon.”

Bioserenity SAS has gained U.S. FDA clearance for the Neuronaute electroencephalography (EEG) system and Icecap EEG wearable device, which aim to help physicians remotely monitor and assess electrical brain activity of people with epilepsy. The company noted that the Icecap and Neuronaute system will facilitate access to care in a variety of settings, including rural and remote environments.

The U.S. FDA’s safer technologies program, or STeP, is designed in part as a complement to the breakthrough devices program, but the September 2019 draft guidance lent little clarity as to what might constitute a significantly safer device. The Jan. 5, 2021, final guidance does little to clarify that question, however.