News & Updates

Arterys receives FDA clearance for Cardio DLTM application

Arterys, a pioneer in cloud-based medical imaging software, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Arterys Cardio DLTM application. Arterys Cardio DLTM is the first technology to be cleared by the FDA that leverages cloud computing and deep learning in a clinical setting. Arterys Cardio DLTM provides automated, editable ventricle segmentations based on conventional cardiac MRI images that are as accurate as segmentations performed manually by experienced physicians. The US clearance complements the CE Mark received in late December for commercialization of the Arterys Cardio DLTM product in Europe. Unlike traditional medical imaging software, Arterys Cardio DLTM uses deep learning, a form of artificial intelligence, to automate time-consuming analyses and tasks that are performed manually by clinicians today. The physician can edit the automated contours if desired. These images show the Cardio DLTM generated contours of the insides and outsides of the ventricles of the heart. The software can process a scan in just 10 seconds, compared to manual contouring performed by clinicians. The Arterys Cardio DLTM application is vendor agnostic and was developed using data from several thousand cardiac cases. The sof tware produces editable automated contours, providing precise and consistent ventricular function in seconds. The trained deep learning algorithm was validated as producing results within an expected error range comparable to that of an experienced clinical annotator. This clearance enables Arterys to make use of its unique clinical annotation platform, which collects ground-truth data every time a user views a study on Arterys.com. In the future, the deep learning model can be optimized as new data is collected from all global users. Both the FDA clearance and CE Mark expands on the recently 510(k) cleared 4D Flow post-processing software features that provide comprehensive anatomy and blood flow visualization and quantification within and around the heart in a simple manner. Royal Philips showcased innovative connected health products and solutions that empower consumers to become ever-more engaged in their health. Leveraging Philips’ expertise in the consumer and professional healthcare domains, and the advanced analytics and computing power of the company’s secure HealthSuite cloud platform, these new connected digital health products and services further illustrate Philips’ commitment to delivering meaningful innovations for every stage of life – from birth to healthy living and healthy aging.  “The personal and professional healthcare worlds are converging, with traditional models of care being challenged at every turn, and connected digital technology is now the key to empowering consumers to take care of their health and that of their loved ones,” said Pieter Nota, CEO Personal Health Businesses and Chief Marketing Officer, Royal Philips. “In areas such as oral health, mother and child care, sleep and respiratory care, heart health, and home monitoring, Philips is