LivaNova (NSDQ:LIVN) announced that some of its cardiopulmonary products are now permitted for extended use in specific therapies after the FDA expanded device availability amid the COVID-19 pandemic. On April 6, the FDA issued guidance to temporarily expand the availability of certain devices in an effort to address the coronavirus crisis. Along the guidelines given by […]
FDA
FDA issues EUA for Sterilucent N95 hydrogen peroxide sterilization
The FDA has granted Sterilucent emergency use authorization (EUA) for its hydrogen peroxide sterilizer for use with N95 and N95-equivalent respirators — the latest in a string of mask sterilizers receiving EUAs amid the coronavirus pandemic. Minneapolis-based Sterilucent’s HC 80TT vaporized hydrogen peroxide sterilizer may now be used to decontaminate the single-use compatible respirators that […]
FDA grants breakthrough designation to CytoSorb blood purification tech
CytoSorbents (OTC:CTSO) announced that it received FDA breakthrough device designation for its CytoSorb blood purification technology for use during emergent and urgent cardiothoracic surgery. Monmouth Junction, N.J.-based CytoSorbents designed its CytoSorb technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients. The FDA breakthrough nod is for the use of CytoSorb for […]
BREAKING: LabCorp at-home COVID-19 test gets FDA EUA nod
The FDA announced today that it granted emergency use authorization (EUA) for an at-home COVID-19 diagnostic test from Laboratory Corporation of America (NYSE:LH). LabCorp received EUA for its COVID-19 RT-PCR test last month, saying at the time that it would rapidly expand its testing capabilities with the expectation of more than 20,000 tests performed per […]
Are coronavirus antibody tests all they’re cracked up to be?
With pressure mounting to get Americans back to work, the new focus is on tests that purport to indicate antibodies to the SARS-CoV-2. These serological tests are supposed measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. Many companies in China have […]
FDA: Coronavirus may extend medtech application reviews
The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in […]
FDA approves Q-tip-like swabs to allow patient self-testing for COVID-19
The FDA announced today that spun synthetic swabs — with a design similar to Q-tips — could be used to collect samples from patients suspected of having COVID-19. Patients could even take the samples themselves from the front of the nose, the agency said. The solution could help solve multiple problems: The nationwide shortage of […]
RefleXion Medical raises $100m for biology-guided cancer radiotherapy
Therapeutic oncology company RefleXion Medical announced today that it closed an equity financing with proceeds of $100 million. Public Sector Pension Investment Board (PSP Investments), a large, Canada-based pension investment manager focused on long-term investments, led the funding, according to a news release. Existing investors TPG’s The Rise Fund, KCK Group, Sofinnova Partners, Venrock, T. […]
Stryker gains emergency nod for respirator decontamination
The FDA has granted Stryker (NYSE:SYK) an emergency use authorization to decontaminate used N95 respirators using the company’s Sterizone VP4 sterilizer during the coronavirus outbreak. The Sterizone VP4 uses vaporized hydrogen peroxide to sterilize up to 20 of the masks in one cycle, according to the FDA. Stryker’s sterilizer is the fourth that uses vaporized hydrogen […]
BREAKING: FDA authorizes U of Minnesota, Boston Scientific’s low-cost ventilator
The FDA today issued emergency use authorization (EUA) for a low-cost ventilator developed by the University of Minnesota and produced by Boston Scientific (NYSE:BSX). Minnesota’s Coventor device made waves last month after researchers touted the design made from various parts totaling just $150. It’s now the first ventilator of its kind authorized for use under the […]
Xenocor wins FDA nod for 5 mm articulating laparoscope
Xenocor announced that it received FDA clearance for its Xenoscope disposable 5mm articulating laparoscope for abdominal and thoracic surgery. The Salt Lake City-based company designed its latest laparoscope to improve image quality, reduce fog, lower hospital costs and reduce bio-hazard risk for the patient and staff. Xenocor’s new Xenoscope includes a disposable 5mm camera on […]