Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Babson Diagnostics, Circadia Health, Ekso Bionics, Medtronic, Nyxoah, Viraxclear.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aethlon, Icotec, Naviswiss, Pear Therapeutics, Sirakoss.
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.
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.
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.
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.
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.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cue Health.
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