Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.
Digital therapeutics have had a tough time gaining traction in the last few years. They’ve been hampered by sometimes reluctant payers, providers and regulators who lack familiarity with the approach, which typically employs an app or other technology to treat a patient by supporting behavioral adjustments.
Wearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed the detection of a range of conditions, is open to people in the U.S. ages 22 and older who own a Fitbit that tracks heart rate.
BOGOTA, Colombia – As it works to more efficiently fight COVID-19, Chile is developing new regulations to support and boost telemedicine with an eye on the current outbreak but also on improving the provision of health care in the country in the long term. Patients with chronic conditions, who are at a greater risk from COVID-19, are being prioritized as the focus for telemedicine progresses.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bio-Rad, Euroimmun, Lifesignals, Nuvasive, Vitalconnect.
HONG KONG – Israeli companies have produced some promising med-tech solutions for COVID-19, and the artificial intelligence space is turning out to be a particularly strong area of expertise for that tiny but mighty nation. One of the four health maintenance organizations (HMO) in Israel, Maccabi Healthcare Services, has deployed a new AI-powered algorithm that identifies individuals estimated to be at the highest risk of severe COVID-19 complications due to pre-existing conditions and other health factors.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cerus, Novartis, Roche, Zoll.
PERTH, Australia – Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work.
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