Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Siemens Healthineers.
PERTH, Australia – Australian digital health company Resapp Health Ltd. received clearance from Australia’s Therapeutics Good Administration and CE mark certification in the EU for its stand-alone cough counter application that tracks cough frequency using a smartphone. The class I software as a medical device is the first regulatory approval for such an application, which uses Resapp’s machine learning algorithms to identify cough events from audio recorded using the smartphone’s in-built microphone.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Co-Defend, Co-Protect, Lucira, Pacbio, Seegene.
As global demand for rapid testing soars due to a new variant of COVID-19, one company is shaking up the diagnostics market with an at-home rapid PCR solution. Founded in 2017 by scientist and entrepreneur Jonathan Rothberg, Detect Inc. is the developer of Detect COVID-19, a direct-to-consumer PCR test that provides results within one hour.
The FDA has posted two draft guidances for the transition of policies from the pandemic to more normal times. One of these is the long-awaited draft for transitioning a device from an emergency use authorization (EUA) to a conventional premarket status, which offers a 180-day grace period for an EUA after the agency identifies a date on which the EUA will be terminated.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avacta, Phillips, Sight Sciences.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: BD, Carestream Dental, Cue Health, Envista, Everly Health, Ixensor, Lucira, Nevro, Nalu.
Becton, Dickinson and Co. (BD) completed its acquisition of Scanwell Health Inc., its partner in development of the smartphone-enabled BD Veritor At-Home COVID-19 Test, just in time for increased demand driven by the Omicron surge in the U.S. and plans to make the tests available for free by the federal government as well as several states and large municipalities. Currently, most of the tests distributed by governments are made by Abbott Laboratories, which received emergency use authorization (EUA) for its at-home test in March 2021.