The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.
SciBase (SCIB) Stockholm, Sweden - announced today that it has received approval from the US Food and Drug Administration (FDA) for Nevisense 3.0, the third generation of their Nevisense system for early melanoma detection.
Phase 1/2 Clinical Trial for ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery Will Begin Enrollment at the University California San Diego (UCSD), Stanford and Harvard
By: Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health
VitalPatch® wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other COVID-19 treatments
BOX BioScience has formed a joint venture with Singlepoint (OTC: SING) to distribute hand sanitizer products manufactured out of Carlsbad, CA.
New large catheter platform FDA cleared to remove blood clots from peripheral vessels
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®.
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.
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.
Demand for antibody tests continues to grow as Texas reopens economy
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.
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.
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.
Qualitative test for the detection of nucleic acid from SARS-CoV-2
New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature
Authorization brings more instruments on line, enables workflow flexibility and simplifies methods to increase throughput and allow more labs to run tests
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).
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.
FDA Continues Effort to Protect Public from Fraudulent and Potentially Harmful Products