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.
Chronic disease patients are facing serious risks both from keeping away from necessary care settings, as well as from potential COVID-19 infection. One in five chronic disease patients was already starting to avoid seeking care in physician’s offices and hospitals, according to a survey that started early last week of a panel of 1,300 chronic disease patients across several indications.
As companies scramble to develop diagnostic tests and vaccines for COVID-19, there is a need for effective treatments for patients suffering severe respiratory effects from the novel coronavirus. To that end, Beyond Air Inc., of Garden City, N.Y., and Rehovot, Israel, has applied to the U.S. FDA to conduct an IDE trial of its inhaled nitric oxide (NO) system, Lungfit Bro, in COVID-19 patients.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Ariosa Diagnostics, Illumina, Transmedics.