Fri, 02-Dec-2022

U.S. Food and Drug Administration

FDA Approves Genentech’s Enspryng for Neuromyeliti...

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng (satralizumab-mwge) as the subcutaneous treatment for adults living with anti-aquaporin... August 17, 2020 6:17 am By Neha Mule

FDA Issues Emergency Use Authorization for Impella H...

The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients ... August 6, 2020 6:56 am By Neha Mule

Blue Eye Soft Announces Commodity Designation and FD...

Blue Eye Soft, an IT-solutions and software development company, announced that it has received acknowledgment from the U.S. Food and Drug Administration (FDA) of its Pre-Submission package for its proprietary... July 21, 2020 8:35 am By Neha Mule

Ambu Receives FDA Clearance for its Sterile, Single-...

The Ambu aScope Duodeno received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on 17 July 2020 and is now ready for commercial launch as planned. “At Ambu, we are determined to adv... July 17, 2020 12:16 pm By Neha Mule

XACT ACE Robotic System Cleared by FDA for Image-Gui...

XACT Robotics Ltd. announced that its XACT ACE Robotic System was cleared to market in the U.S. for computed tomography (CT) guided percutaneous procedures. ACE is XACT’s second-generation proprietary robot... July 16, 2020 12:02 pm By Neha Mule

Pfizer, BioNTech’s Coronavirus Vaccine Candidates ...

Pfizer Inc and partner BioNTech SE said on Monday two of their experimental coronavirus vaccines received ‘fast track’ designation from the U.S. health agency, speeding up the regulatory review process. ... July 13, 2020 3:16 pm By Neha Mule

AI Helps Clinicians to Make Quick and Accurate Decis...

Healthcare is witnessing adoption of various technologies, right from diagnostics to patient’s treatment. Artificial intelligence are one of these technological trends that is used in various practices in di... July 13, 2020 1:44 pm By Neha Mule

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