Uncategorized

FDA grants clearance for AI-powered cardiac tech from UltraSight

UltraSight has announced that the FDA has granted clearance for its AI-powered ultrasound guidance technology, which is designed to “assist medical professionals without sonography experience in acquiring cardiac ultrasound images at the point of care in multiple settings”, with the aim of supporting detection of heart disease and providing patients with easier access to cardiac monitoring.

The software is described as “an accessory for point of care ultrasound systems”. When paired with a compatible device, the underlying AI neural network can predict the position of the ultrasound probe relative to the heart, and guides the user to manoeuvre the probe in order to capture diagnostic quality cardiac images.

It is hoped that the solution will support patient triage by enabling “increased efficiency and clinical confidence” along with increasing patient access by bringing cardiac ultrasound into local communities.

The FDA’s clearance follows a study from UltraSight which “demonstrated that with real-time guidance of the ultrasound probe and feedback on the quality of the ultrasound image, medical professionals without prior ultrasound experience can acquire diagnostic quality images.”

Roberto Lang, director of cardiovascular imaging at the University of Chicago, says: “UltraSight’s real-time AI guidance is a game-changer for diagnostic efficiency and experience. Now, with regulatory clearance, medical professionals and patients alike can benefit from this transformative cardiac imaging solution.”

UltraSight’s CEO Davidi Vortman adds: “The issues arising from the disproportion between the number of heart disease patients and availability of cardiac ultrasound was a key driver for the company’s founding team. The need to solve this significant disparity is why we applied deep geometrical machine-learning techniques to cardiac ultrasound, and what we found is that AI has the potential to close the skillset gap – empowering medical professionals to successfully acquire timely and accurate cardiac ultrasound images anywhere. With FDA clearance, we can now move forward with bringing our innovation to market and ultimately advancing patient care for the millions in need.”

On the topic of cardiac tech, the start of this year, we covered how Blackpool Teaching Hospitals NHS Foundation Trust, Lancashire and South Cumbria Integrated Care Board and Fylde Coast Medical Services are collaborating with remote monitoring technology provider Docobo with the aim of implementing a solution capable of providing a direct link between patients awaiting cardiac surgery and a team of clinicians.

At the end of the last year, we highlighted how researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield developed an AI tool which aims to provide “quick and comprehensive analysis of heart function to aid earlier and more detailed diagnosis.”