The U.S. FDA has given the greenlight to Eko Devices Inc.’s electrocardiogram (ECG)-based algorithm to aid in detecting patients with heart failure during the COVID-19 pandemic. The artificial intelligence (AI)-powered algorithm, which provides a quick way to screen for low ejection fraction, won FDA breakthrough status in December of 2019.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Critical Alert, Eko, Novocure, Optina Diagnostics, Zai Lab.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Access Scientific, Apiject, Atrium Health, Butterfly Network, Canon Medical, Carmat, Centene, Change Healthcare, Dermalog, DNA Electronics, The DNA Company, Drӓgerwerk, Edap Tms, Exact Imaging, Liva Healthcare, My Next Health, My Pain Sensei, Nuvo Group, Polyganics, Rapid USA, REMsleep Holdings, Smiths Medical, Surfacide, Thermo Fisher Scientific, United Healthcare Services, Wuxi Diagnostics, Xleratehealth.
If nothing else, the unfolding coronavirus has advanced the implementation of a wide variety of digital health tools. Panelists at the World Medical Innovation Forum on May 11 explored several current use cases.
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.