Becton Dickinson’s Vacutainer Gets EUA for COVID-19 July 27, 2021 The specimen collection tubes are in short supply because of the increased demand during the public health emergency, the agency said. Read More
Australia’s Omniscient Gets 510(k) Clearance for Digital Brain Mapping Platform July 26, 2021 The software “assists neurosurgeons in making more informed decisions and reduces surgical uncertainty,” the company said. Read More
IHS Gets CE Mark for Insignis Syringe Infusion System July 26, 2021 The portable infusion pump delivers medications from a minimal “keep vein open” level up to 250 milliliters per hour, the company said. Read More
Synapse Biomedical’s TransAeris Deemed FDA Breakthrough Device July 26, 2021 The temporary device is used to prevent or treat ventilator-induced diaphragm dysfunction. Read More
PathogenDx Gains CE Mark for COVID-19 Test July 26, 2021 The system can test pooled samples to detect the virus in multiple samples at one time. Read More
Philips’ IVC Filter Remover Named Breakthrough Device July 23, 2021 The laser device is used for ablating tissue to enable the removal of an IVC filter when other methods of removal have failed. Read More
ZOLL Medical Gets FDA Clearance for Traumatic Brain Injury Software July 23, 2021 The dashboard displays numeric and graphical trend data on hypotension, hypoxia and hyperventilation in traumatic brain injury patients. Read More
AnchorDx’s UriFind Deemed a Breakthrough Device July 23, 2021 The test has already earned CE mark certification. Read More
Congenica’s Genomic Analysis Software Gets CE Mark July 22, 2021 The software can run either on local computers or be used via the cloud. Read More
North American Diagnostics’ COVID-19 Antigen Test Earns CE Mark July 22, 2021 The company said it will file for Emergency Use Authorization from the FDA after it completes supplemental clinical trials of the test. Read More
NeuroMetrix’s Fibromyalgia Device Deemed Breakthrough Device July 22, 2021 The company is moving forward with a regulatory filing and hopes to launch the product in the second half of next year. Read More
Agilent’s Lung Cancer Assay Wins Expanded CE Mark July 22, 2021 The assay’s companion diagnostic can help guide treatment decisions, the company said. Read More