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 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 showcasing its ecosystem of connected products and ser vices at CES, once again demonstrating its leadership in the world of digital health.” Philips’ new consumer health products and services are powered by the Philips HealthSuite cloud, allowing consumers to combine their health data and use it in smarter and more meaningful ways to support a healthier lifestyle, manage their health conditions and connect and share data with their healthcare professionals. Key product innovations being showcased at CES 2017 include: Philips Avent uGrow1 digital parenting platform: Designed to help new parents understand and support their baby’s healthy development, the uGrow app connects wirelessly to the Philips Avent smart baby monitor and smart ear thermometer as well as collating manually inputted data such as feeding and sleeping patterns Philips DreamStation Go portable CPAP technology: Compact, lightweight and slim enough to pack in a carry-on flight bag or briefcase, Philips’ soon-to-be released DreamStation Go means users never have to miss out on CPAP (Continuous Positive Airway Pressure) therapy when traveling. Philips Heart Health program:An app-based behavior change program aimed at reducing lifestyle-induced risk factors for cardiovascular disease in adults. Philips digital oral care management platform: The Philips Sonicare FlexCare Platinum Connected toothbrush uses unique smart sensor technology inside the toothbrush and personalized coaching to help improve brushing technique, while the Philips Sonicare Breath care system, featuring our new connected Breath analyzer, measures, tracks and helps users improve their breath quality and oral care habits.