Obstructive lung disease treatment developer Nuvaira said today that the FDA has designated its lung denervation system a breakthrough device. The Nuvaira lung denervation system enables a novel bronchoscopic procedure that disrupts pulmonary nerve input to the lung to reduce the clinical consequences of neural hyperactivity, which causes airway hyper-responsiveness or “lung attacks” in both COPD […]
COVID-19
Phosphorus wins FDA EUA for at-home COVID-19 saliva test
Phosphorus today announced it received FDA emergency use authorization for its COVID-19 saliva test for at-home sample collection. The test is the second at-home unsupervised saliva test approved by the FDA so far, according to the company. It is available by ordering online and is available through healthcare and employer partnerships. Saliva tests are simple […]
Sherlock Biosciences announces manufacturing partnership for CRISPR-based COVID-19 test
Sherlock Biosciences announced today that it will collaborate with Integrated DNA Technologies (IDT) to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for COVID-19 detection. Officials at Cambridge, Mass.–based Sherlock Biosciences think the company’s CRISPR-based diagnostic test, which recently received an FDA emergency use authorization, will increase testing capacity and decreasing time to result […]
FDA restricts re-use of certain respirators for COVID-19
Certain respirators made in China and respirators with exhalation valves should not be decontaminated for re-use by healthcare workers, the FDA announced today. The agency revised these respirators’ emergency use authorizations (EUAs) to reflect the changes. The particular respirators from China “may vary in their design and performance,” the FDA said, basing its decision on […]
MedTech 100 roundup: Stocks stand pat in June’s first week
While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease […]
FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests
The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas. Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach […]
Clew Medical gains EUA for predictive screening software for COVID-19
Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive care units. The EUA covers the company’s ClewICUServer and ClewICUnitor. The system is a standalone software that is designated as a medical device. It uses commonly recorded vital signs, nursing assessments, flowsheet data, medications and lab data to compute […]
Survey: Half of heart attack patients avoid the hospital during pandemic
The number of heart attack patients seeking urgent hospital care has dropped by more than 50% worldwide during the COVID-19 outbreak, according to a survey by the European Society of Cardiology (ESC). The survey of 3,101 healthcare professionals in 141 countries was conducted in mid-April.The findings are published in European Heart Journal — Quality of Care and […]
Cantel Medical up on Street-beating Q3
Cantel Medical (NYSE:CMD) shares ticked up today on third-quarter financial results that came in ahead of the consensus forecast. The Little Falls, N.J.-based infection prevention products and services company posted profits of $15.8 million, or 37¢ per share, on sales of $236.9 million for the three months ended April 30, 2020, for a 93.1% bottom-line gain […]
NASA, Fitbit gain EUAs for COVID-19 devices
The FDA granted emergency use authorization (EUA) for emergency COVID-19 ventilator devices developed by Nasa and Fitbit (NYSE:FIT). According to the FDA’s ongoing list of devices granted EUAs, both devices were authorized on June 1. NASA’s VITAL (ventilator intervention technology accessible locally) compressor and the Fitbit Flow are the latest of a few ventilator alternatives to […]
Battelle under fire for decontamination system performance
Major media outlets are questioning the ability of the Battelle Critical Care Decontamination System (CCDS) to safely reprocess used N95 respirators up to 20 times, as the company has claimed. The FDA granted the nonprofit tech development company an emergency use authorization in March for its vaporized hydrogen peroxide system to decontaminate N95 respirators used […]