Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Caption Health, Cardiofocus, Cytosorbents, Helius Medical Technologies, Optiscan Biomedical, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Transit Scientific.
ERTH, Australia – A recent study conducted at the University of Western Australia (UWA) Centre for Sleep Science shows that facial features analyzed from 3D photographs could predict the likelihood of having obstructive sleep apnea.
Palo Alto, Calif.-based Limbix Health Inc. secured $9 million in series A funding for development of Spark, its prescription digital therapeutic (PDT) designed to treat depression in adolescents. GSR Ventures led the round with additional funding from other existing investors, including Sequoia Capital, Storm Ventures, Nextgen Venture Partners and Bixink Therapeutics.
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.
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