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Tag: Food and Drug Administration

Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System™

Patient Enrollment to Begin Within Three Months FREMONT, Calif. and OXFORD, United Kingdom, April 21, 2021 /PRNewswire/ -- Cerus Endovascular Ltd., a privately...

Profound Medical to Release First Quarter 2021 Financial Results on May 12 – Conference Call to Follow

TORONTO, April 21, 2021 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops...

EU Regulator: ‘Possible Link’ Between Johnson & Johnson Vaccine And Rare Blood Clots

Enlarge this image Boxes containing the Johnson & Johnson COVID-19 vaccine,...

First GMO Mosquitoes to Be Released in the Florida Keys

This spring, the biotechnology company Oxitec plans to release genetically modified (GM) mosquitoes in the Florida Keys. Oxitec says its technology will combat...

First head-to-head trial pits psychedelic therapy against antidepressant

A first-of-its-kind clinical trial has pitted a common antidepressant against psilocybin, the main psychedelic compound found in magic mushrooms. The results, recently published...

Ex-FDA Chief Sees ‘Struggle’ To Vaccinate More Than Half U.S. Population

Enlarge this image Dr. Scott Gottlieb, then commissioner of the Food...

Denmark Drops AstraZeneca Vaccine, Citing Rare Side Effects, Epidemic ‘Under Control’

Enlarge this image Danish health authorities announced Wednesday that the country...

COVID-19 may become nanomedicine’s finest hour yet

While we are not suggesting that nanotechnology-based vaccines are the panacea for eliminating all viruses, whether it be Ebola or the seasonal flu,...

CDC, FDA To Review J&J Shot After 6 Blood Clot Cases Reported Out Of Nearly 7M Doses

Enlarge this image The U.S. Food and Drug Administration and the...

FDA Authorizes Marketing of First Device that Uses AI to Help Detect Potential Signs of Colon Cancer

April 12, 2021 — The U.S. Food and Drug Administration (FDA) authorized marketing of Medtronic's GI Genius, the first device that uses artificial intelligence (AI) based...

COVID-19 Home Collection Antibody Test Gets Emergency Use Authorization

The Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System (Symbiotica,...

[Memic in TechCrunch] Memic raises $96M for its robot-assisted surgery platform

Memic, a startup developing a robotic-assisted surgical platform that recently received marketing authorization from the U.S. Food and Drug Administration, today announced that...

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