As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
PERTH, Australia – Australian digital health company Resapp Health Ltd. was down nearly 52% following news that the U.S. FDA rejected its de novo request for its smartphone application for the diagnosis and management of respiratory disease. The agency rejected the application, citing the need for additional information to demonstrate that the “clinical benefits of the device outweigh the risks,” CEO Tony Keating told analysts during a March 12 conference call on the news.
The U.S. capacity for SARS-CoV-2 testing is limited by several items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide 2 million reactions per week, a volume that should increase to 5 million per week in April.
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canon Medical, Quidel.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ambu, ATTC, Biointellisense, Biomerica, Bio-Techne, Centogene, Clinical Laserthermia Systems, Dover, Em-tec, Llamasoft, MeMD, Myriad Genetics, Oxford Nanopore Technologies, Pacific Biosciences of California, Parallax Health Sciences, Qiagen, Rewalk Robotics, Startx, Tomi Environmental Solutions, Tabula Rasa Healthcare, Windgo.
With the high need for ventilators in the face of COVID-19, Ventec Life Systems, of Bothell, Wash., is stepping up with its multifunction ventilator, known as VOCSN, for ventilation, oxygen, cough, suction and nebulization.
Google sister company Verily Life Sciences LLC has been under an unprecedented amount of scrutiny since it was promoted over the weekend by President Donald Trump as responsible for a nationwide information and testing program for the emerging novel coronavirus.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) recently granted the first urgent-use licenses to four COVID-19 novel coronavirus diagnostic kits to battle the pandemic in the country, which is home to one of the largest outbreaks in the world outside of China.
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