Dave Muoio

November 28, 2018
Basking Ridge, New Jersey-based medical device maker Electrocore has received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. According to a release from the company announcing the news, no other devices or pharmacologic treatments have received this indication from the agency. Therapy using the...
November 28, 2018
Amazon Web Services has unveiled a new machine learning tool that looks to help healthcare industry developers process bodies of unstructured medical text. Called Amazon Comprehend Medical, the HIPAA-eligible service is able to pull out medically-relevant information such as patient diagnoses, symptoms, medical test details, treatments and dosages, while simultaneously highlighting any protected...
November 27, 2018
Keyto, a startup building a connected breath sensor and companion app to support users following a ketogenic diet, has raised $2.5 million in seed funding. The round was led by Craft Ventures, and also included additional support from Floodgate Fund, Abstract Ventures and Hydra Ventures alongside Eventbrite cofounders Julia and Kevin Hartz. According to a statement, this investment will be used...

Credit: FDA.gov

November 27, 2018
Yesterday, the FDA announced in a press release that it is eyeing potential updates to the agency’s 510(k) clearance pathway for medical devices. These could include a requirement for more modern predicate devices as well as objective safety and performance criteria during regulatory submission. In the interest of promoting innovation, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren,...
November 26, 2018
Samsung Electronics’ medical device division showed off a selection of new artificial intelligence-based imaging tools yesterday at the Radiological Society of North America’s 2018 Annual Meeting in Chicago. The software are designed to be implemented within diagnostic imaging devices that are already on the market, according to a release from the company. Among these software applications was S-...
November 26, 2018
Yadin Shemmer has been named the new CEO of Mango Health, the maker of a digital medication management platform. Shemmer, who was previously the company’s president, will take over the job from founder Jason Oberfest, who will continue to serve as a special advisor to the company. “I am thrilled to have Yadin take the helm at Mango Health to spearhead the continued growth of the company,”...
November 26, 2018
Monitoring and automatically identifying the symptoms of Parkinson’s disease patients can be achieved using just a single soft wearable sensor placed on the back of the hand, according to an investigation recently published in NPJ Digital Medicine that sought to optimize such methods of data collection. According to the researchers — who employed 20 participants, six different sensors and...
November 26, 2018
As the healthcare industry’s relationship with data becomes increasingly sophisticated, executives, supervisors and other key decision makers have more tools than ever to measure and guide the performance of their organization. Collecting and surfacing new streams of raw data can only help to a certain extent, however, as even the most insightful individuals will struggle to identify actionable...
November 21, 2018
Livongo’s DPP recogized by the CDC. Digital chronic care company Livongo Health’s Diabetes Prevention Program has received full recognition from the CDC, according to a release from the company. The designation implies that the digital offering meets the agency’s standards as a Type 2 diabetes prevention and lifestyle change intervention, and is listed within the CDC’s online referral tool. “CDC...
November 21, 2018
Ascensia Diabetes Care’s Contour Diabetes app — a mobile tool to monitor trends in blood glucose levels that connects to the Contour Next One glucometer — has received yet another update. As of Monday, iPhone users can transfer blood glucose and carbohydrate data from their app to records kept within the Apple Health platform. After opting in, data collected through Ascensia’s app will...