Cardiovascular self-test available for AFib patients
HARROGATE, England – A cardiovascular self-test from Inhealthcare is available to patients with heart conditions on the U.K.’s National Health Service. People at risk of stroke who are prescribed the drug warfarin to prevent blood clotting can test themselves at home and send in their results through a mobile app, web portal or automated telephone call to receive their dosage information. “Our technology allows people with long-term heart conditions to stay on top of their health without the hassle of inconvenient and time-consuming hospital or clinic appointments,” said Bryn Sage, chief executive at Inhealthcare, in a statement. The service is currently available for up to 200 patients with atrial fibrillation.
Insightin app helps patients make health care decisions
GAITHERSBURG, Md. – Insightin Health, a provider of data-driven decision-making technology, has launched an app to help patients make health decisions. The In360 app uses an artificial intelligence-driven chatbot to look into members clinical and claims data, along with any other engagement activities, to create a health assistant approach to guide consumers towards preventative care. “Consumers increasingly want to the power to proactively self-manage their preventative health and chronic conditions,” said Michael Wood, director of strategy and product development at Insightin Health, in a statement. “They also want to feel that experience is personalized and speaks to them directly—that’s what In360 delivers.” The app is the first of multiple AI and machine learning consumer-facing features that will be launched as part of the overall personalized health care delivery through the Insightin Health platform.
Qualcomm develops biometric patches
SAN DIEGO – Qualcomm Life has designed and developed reference designs for cost-effective, connected and medical-grade biometric patches that will enable health care professionals to monitor patients across the care continuum with access to near real-time data. “This wearable patch technology will be transformative in its ability to provide timely and accurate data to enable care providers to make better-informed decisions,” said Dr. James Mault, senior vice president and chief medical officer at Qualcomm Life, in a statement. The patches measure a variety of biometric parameters, including clinical thermometry and sophisticated motion measurements. Benchmark Electronics, a provider of integrated electronics manufacturing, design and engineering services, will license the reference designs and serve as the device design and manufacturer of record with the U.S. Food and Drug Administration for the sensors. “This low-power, cost-effective, single-use design will fuel new, scalable care models as we transition as an industry from episodic, reactive care to more continuous, proactive, intelligent care,” said Mault. Clinical validation is currently underway, and the patches are slated to be commercially available through Benchmark in 2018.
PhysIQ earns cybersecurity award
ARLINGTON, Va. – PhysIQ was selected winner of the 2017 MyVCM Trust Network Awards, presented by Ostendio, a provider of cybersecurity and information management solutions. “Throughout the year, PhysIQ has demonstrated their dedication to maintaining high levels of security and has consistently ranked in the top five of the monthly MyVCM Awards,” said Grant Elliott, CEO of Ostendio, in a statement.
PhysIQ’s portfolio of technologies includes solutions that capture, transport, store and analyze continuous telemetry from wearable sensors and present personalized physiology analytics for their customers in health care, wellness and clinical trials markets. “Protecting data is extremely important to us, and we take it seriously,” said Matt Pipke, chief technology officer at PhysIQ, in a statement.
Lightbeam Health integrating AI for diabetes prevention
IRVING, Texas – Population health management provider Lightbeam Health Solutions is integrating artificial intelligence technology into its DocSynk platform to improve identification and targeting of patient groups to reduce costs and improve quality. “We’ll apply this technology to real-world problems in support of our clients as they operate in a way that rewards value over volume,” said Pat Cline, CEO of Lightbeam Health Solutions, in a statement. One of the initial targets of the integration is identifying prediabetics and undiagnosed diabetics to support programs such as the Medicare Diabetes Prevention Program. Lightbeam also intends to turn the technology toward predicting visits to the emergency department before they happen.
Novo Nordisk, HITLAB seeking health tech innovation for World Cup Challenge
NEW YORK – Novo Nordisk has teamed up with Health Innovation Technology Lab to launch the 2017 HITLAB World Cup of Voice-Activated Technology in Diabetes presented by Novo Nordisk. “This is the first time we are focusing the World Cup on a single disease—diabetes—and specific area of technology,” said Stan Kachnowski, HITLAB chair, in a statement. “The need couldn’t be greater, and I am sure ideas are in development all around the globe. Together with Novo Nordisk, we want to accelerate the rate of breakthrough technologies that will help millions of people living with diabetes worldwide.” Winning entries should demonstrate an ability to effectively address the unmet needs of the type 2 diabetes community. Projects must show how the voice-activated technology solution differs from current practice, technology, or services available to consumers, and they must provide a sound, sustainable business model. HITLAB has hosted the challenge since 2006. Last year, 74 teams from 14 countries presented technology innovations. Past winners have since raised over $50 million in follow-on investment funding. Prizes totaling $75,000 will be awarded.
VitalBand raises funds for fall detection watch
PLANO, Texas – VitalBand has kicked off an Indiegogo campaign to fund its smart watch, which automatically detects if the user falls. By setting pre-programmed contacts, the watch automatically calls out and texts in the event of a fall, or when the panic button is pressed. The device also monitors vital signs and activity levels, and can be programmed for medication reminders.
Mayo Clinic adds online symptom checker to portal
ROCHESTER, Minn. — The Mayo Clinic has added an online symptom checker to its patient portal. Through Ask Mayo Clinic online, users are guided through a series of questions about presenting symptoms. Based on those responses, they will receive a recommended level of care. The tool is driven by standardized algorithms based on the real-time data entered by users; it uses 36 algorithms that cover more than 300 common symptoms. “Care guidance, based on the user’s selection of symptoms and responses to relevant questions, includes more information about possible causes tied to the symptoms, and, in most cases, provides recommendations on home care in non-emergent situations,” said Dr. Sandhya Pruthi, associate medical director of Mayo Clinic Global Business Solutions, in a statement. All symptom assessment content is developed by Mayo Clinic health care provider and nurse experts. Content is regularly reviewed and edited to ensure accuracy.
Chris Pittman named to Tactile Medical board
TAMPA, Fla. – Dr. Chris Pittman has been appointed to the scientific advisory board of Tactile Medical, makers of at-home devices to treat lymphedema and chronic venous insufficiency. Pittman is CEO and medical director of Vein911 Vein Treatment Centers. Tactile’s scientific advisory board includes international medical experts who assist the company in strategies around clinical development, guidance on operating plans, and drivers for reimbursement and sales/marketing activities.
Companies selected for FDA Pre-cert program
SILVER SPRING, Md. – The U.S. Food and Drug Administration has announced the names of the companies selected to participate in its Pre-cert pilot program aimed at streamlining the agency’s approach toward digital health technology.
The pilot participants include Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsun, Tidepool, and Verily.
“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement.
The goal of the Pre-cert program is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify it.
With the information gleaned through the pilot, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program.
The FDA is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for pre-market review in some cases.
“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said Gottlieb. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
The FDA received interest in the program from more than 100 companies. In selecting the participants, the agency considered several factors including company size, demonstrated record of quality and organizational excellence, clinical focus area and the risk profile of the product. The FDA’s selection process identified companies that represent different perspectives and unique approaches to digital health technology development.
“We are extremely appreciative of the tremendous interest in participating in the FDA Pre-cert pilot program,” said Bakul Patel, associate director for digital health in the FDA’s Center for Devices and Radiological Health, in a statement. “The number of applicants speaks to the significant impact this approach could have on facilitating timely advancement of software that has the potential to benefit health.”
As part of the Pre-cert pilot program, participants have agreed to provide access to measures they currently use to develop, test and maintain their software products, including ways they collect post-market data. Participants also agreed to be available for site visits from FDA staff, and provide information about their quality management system.
The FDA plans to share public updates about the Pre-cert pilot program via the pilot program webpage, as well as through stakeholder meetings, including a January 2018 workshop.