We are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions.
Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate® catheter.
Everlywell's FDA-authorized home collection kit for COVID-19 will be available for individuals and organizations later this month
During Initial Limited Commercial Launch, Nerivio® Was Used more than 30,000 Times to Address Migraine Pain and other Symptoms
After eight years of scientific research and clinical trials, Q30 Innovations announced that it has submitted a request for De Novo classification to the U.S. Food and Drug Administration, seeking authorization to market the Q-Collar in the United States.
Crucial findings published in AACC's Clinical Chemistry journal
FDA Continues Effort to Protect Public from Fraudulent and Potentially Harmful Products
The U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19.
Optina Diagnostics announces today that it received 510(k) clearance for its ophthalmic camera, the Mydriatic Hyperspectral Retinal Camera (MHRC-C1), by the U.S. Food and Drug Administration (FDA).
Authorization brings more instruments on line, enables workflow flexibility and simplifies methods to increase throughput and allow more labs to run tests
New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature
Qualitative test for the detection of nucleic acid from SARS-CoV-2
During COVID-19, the U.S. Food and Drug Administration will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections.
Abbott announced today that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test on the Alinity™ i system.
U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or "rearranged during transfection"). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.
Demand for antibody tests continues to grow as Texas reopens economy
OPTI Medical Systems, Inc., a subsidiary of IDEXX Laboratories, Inc. (NASDAQ: IDXX), announced that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the OPTI® SARS-CoV-2 RT-PCR laboratory test kit for the detection of SARS-CoV-2, the virus that causes COVID-19.
U.S. Food and Drug Administration is providing an update on the agency’s efforts to combat the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.
DILIsym Services, Inc., a Simulations Plus company (Nasdaq: SLP) and a leading provider of simulation and modeling software for pharmaceutical safety and efficacy, today announced that the U.S. Food and Drug Administration (FDA) has again renewed its multi-seat license for the company’s leading quantitative systems toxicology (QST) modeling software, DILIsym®.
New large catheter platform FDA cleared to remove blood clots from peripheral vessels