FDA de novo
ArteraAI Prostate uses digital pathology images from a patient’s biopsy to predict potential long-term outcomes of their prostate cancer.
The news comes about a week after AppliedVR announced it raised $36 million in Series B funding.
Mahana Therapeutics' Parallel is a three-month digital treatment that logs patients' symptoms to deliver relevant guidance and teach them condition-management skills.
NightWare's digital therapeutic monitors a wearer's heart rate and movement to detect disturbances during sleep, and delivers gentle vibrations to interrupt a nightmare without waking the user.
The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.
The clearance of Tandem Diabetes Care’s Control-IQ Technology opens the door for new algorithms enabling hybrid closed-loop diabetes management systems.
The Tandem Diabetes Care t:Slim X2 can work in tandem with other blood sugar management devices, or on its own.