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BioWorld - Monday, January 26, 2026
Home » Topics » Medical devices » Digital health

Digital health
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Regulatory actions for June 18, 2020

June 18, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss.
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Telehealth illustration

Senate HELP Committee considers telehealth after pandemic

June 17, 2020
By Meg Bryant
The COVID-19 pandemic has fueled an unprecedented uptick in telehealth use, from medical and behavioral health services to remote patient monitoring, as federal and state regulators have relaxed certain policy restrictions to increase access to care. Sen. Lamar Alexander (R-Tenn.) recommended in a Senate hearing that certain temporary policy changes, such as elimination of the “originating site” rule and expansion of Medicare- and Medicaid-covered telehealth services, should be lasting to ensure patients retain health care access when the crisis is over.
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Terramera Scientist conducting research and development

Digital supercluster to spend nearly CA$60M to fight coronavirus now and in the future

June 17, 2020
By David Godkin
TORONTO – What do agricultural pesticides and concealed weapons have to do with med-tech advances in fighting COVID-19? Plenty, according to Canada’s science and industry ministry.
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Multiple computer screens showing various views of ClewICU software

Clew snags EUA for COVID-19 predictive screening tool

June 16, 2020
By Meg Bryant
Clew Medical Ltd., of Netanya, Israel, has secured an emergency use authorization (EUA) from the U.S. FDA for its ClewICU system for use with COVID-19 patients in intensive care units (ICUs). The screening system is a standalone software as a medical device product that uses vital signs, laboratory data, medications and other information to assess the likelihood a patient has been infected with SARS-CoV-2, the virus that causes COVID-19.
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Walking with cane

FDA grants breakthrough status to Medrhythms’ chronic stroke digital therapy

June 15, 2020
By Meg Bryant
Medrhythms Inc., a digital therapeutics startup based in Portland, Maine, won an FDA breakthrough device designation for its Rhythmic Auditory Stimulation (RAS) treatment platform for people with chronic walking impairments due to stroke.
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Wheezo product image

Respiri launches wheezo asthma monitoring app

June 15, 2020
By Tamra Sami
PERTH, Australia – On the heels of an AU$5 million ($US3.47 million) capital raise, digital health company Respiri Ltd. is preparing to launch its digital wheezo asthma measurement device in Australia as it transforms itself from a device manufacturer to an eHealth software as a service company (SaaS). Melbourne-based Respiri received its first batch of 500 wheezo devices in March, and the company plans to deploy them in Australia this quarter.
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Other news to note for June 15, 2020

June 15, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Berry Genomics, Biospherix, Dariohealth, Genetron, Hawkeye Systems, Htg Molecular Diagnostics, Nanotronics, Patientsafe Solutions, Personalis, Royal Philips, Sexton Biotechnologies, Sorrento Therapeutics, Terramera, Thermo Fisher Scientific.
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Gold wireframe handshake

As pharmas struggle with digital health, Roche moves in for more with digital therapeutics

June 12, 2020
By Stacy Lawrence
Now that Roche Holding AG has digested its Foundation Medicine and Flatiron acquisitions from a few years ago, it has looked to add more digital capabilities in a couple of recent deals. The earlier big-ticket tie-ups by the Basel, Switzerland-based pharma added genomic and real-world data analytics to deepen the knowledge driving Roche’s R&D efforts, particularly in oncology.
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Regulatory actions for June 12, 2020

June 12, 2020
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
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Other news to note for June 12, 2020

June 12, 2020
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abound Bio, Advanced Molecular Services, Doctor On Demand, Foundation Medicine, Health Technology Solutions, Innovaqor, Integral Molecular, Lexent Bio, PRA, Quidel, Rennova Health, Tpt Global Tech.
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