Cerus Corp., of Concord, Calif., is teaming up with several collaborators in its home state, with an eye toward optimizing convalescent plasma therapy for COVID-19 patients.
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.
Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
Aegea Medical Inc., of Menlo Park, Calif., has received U.S. FDA approval for its next-generation Mara water vapor ablation system, the only endometrial ablation treatment that uses vapor to treat heavy menstrual bleeding. The first commercial procedure was performed by Kirk Brody, an obstetrician-gynecologist in Chattanooga, Tenn.
Like so many other ventilator providers in recent days, Resmed Inc. has committed to ramping up production. It aims to triple its ventilator output and multiply its ventilation mask production by 10. But the San Diego-based company’s specialty is not mechanical ventilation that requires intubation, which is most commonly used in the intensive care unit (ICU), although it does produce some of those.
The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
San Jose, Calif.-based Align Technology Inc. has won the FDA’s nod for its Itero Element 5D imaging system. The company said the Itero Element 5D is the first intraoral scanner with near-infrared imaging (NIRI) technology that visualizes the internal structure of the tooth in real time. The FDA cleared the device for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
The pressure is rising on the Trump administration to activate the Defense Production Act (DPA) for the COVID-19 outbreak as the Senate yet again reconsiders an economic stimulus package. Sens. Brian Schatz (D-Hawaii) and Chris Murphy (D-Conn.) unveiled the Medical Supply Chain Emergency Act in an effort to force the White House to mandate the production of needed supplies, a bill that is likely to languish until Congress can move on economic relief legislation.
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