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As the cases of COVID-19 continue to mount around the world, hospitals and other providers are looking to virtual tools, apps and other products to help people check their symptoms and get advice on whether medical intervention is needed. To that end, Dublin-based Medtronic plc has launched two new tools to help clinicians assess, monitor and triage patients with respiratory symptoms and concerns about the coronavirus.
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.
The U.S. FDA has OK’d expanded labeling for Physiq Inc.’s continuous remote monitoring system, Pinpointiq, for use during the COVID-19 pandemic. The machine learning-based platform, including Multivariate Change Index (MCI), will allow clinicians to track physiologic changes in homebound, quarantined or high-risk patients with confirmed or suspected COVID-19 – freeing up hospital beds for the most severe cases and reducing exposure of doctors and nurses to the highly contagious disease.
Keeping you up to date on recent developments in diagnostics, including: Improving TBI prognosis; Speeding detection of antibiotic resistant infections; Multistep method wrests causality from GWAs; In blood stem cells, selection drives driver mutations early on.
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.
The U.S. FDA has granted an emergency use authorization (EUA) to Cepheid Inc., of Sunnyvale, Calif., for a rapid molecular diagnostic to detect SARS-CoV-2, the virus that causes COVID-19. The Xpert Xpress SARS-CoV-2 test is designed for the qualitative detection of the novel coronavirus and runs on the company’s automated Genexpert systems, with a turnaround time of about 45 minutes.
With the number of COVID-19 cases continuing to rise and with people social distancing and quarantining, at-home diagnostics and telehealth offer the means for doctors and patients to get vital answers and care without meeting face to face. Now, Los Angeles-based Scanwell Health has gained exclusive rights to license and distribute a rapid serology test from Innovita Biological Technology Co. Ltd., of Hebei, China, for at-home testing of SARS-CoV-2, the coronavirus that causes COVID-19.
Abbott Laboratories, of Abbott Park, Ill., is the latest company to receive emergency use authorization (EUA) from the U.S. FDA for a test to detect SARS-CoV-2, the novel coronavirus responsible for the COVID-19 pandemic. The company said it is shipping 150,000 Realtime SARS-CoV-2 tests immediately to existing customers in the U.S., with plans to produce 1 million tests a week by the end of the month.
Keeping you up to date on recent developments in diagnostics, including: ‘Virtual peer review’ aids cancer diagnosis; Adding spirometry to lung cancer screenings to detect undiagnosed COPD; See in 3D; AI and sleep medicine.
Sight Sciences Inc., of Menlo Park, Calif., scooped up $30 million in a series E preferred stock financing round that was led by D1 Capital Partners. The funds are earmarked to further advance clinical and operational development and support commercial expansion of the company’s Omni surgical and Tearcare systems.
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...
As the COVID-19 outbreak continues to dominate the news, an increasing number of companies have come forward to help. For its part, CHF Solutions Inc., of Eden...
BEIJING – Beijing-based Sihuan Pharmaceutical Holdings Group Ltd. said it has initiated clinical trials of broad-spectrum antiviral favipiravir to treat COVID-19....
Mallinckrodt plc is engaging with the U.S. FDA, NIH and the Biomedical Advanced Research and Development Authority to address the potential use of its INOmax...
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....
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