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Food and Drug Administration

FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes

The U.S. Food and Drug Administration approved Lantidra, the first allogeneic (donor) pancreatic islet cellular therapy made from deceased donor pancreatic cells for the...

FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc. (Japan) – Enhance Cardiovascular Diagnostic Accuracy

The US Food and Drug Administration has approved the use of iTFlow in blood flow analysis. The FDA approval is significant as it recognizes...

MedCrypt and Stratigos Security Partner to Offer Specialized Penetration Testing and Security Assessments for Life-Saving Medical Devices

MedCrypt Inc., the proactive cybersecurity solutions provider for medical device manufacturers, including seven of the top 10, they announced its partnership with Stratigos Security,...

U.S. Food and Drug Administration Approves FoundationOne Liquid CDx as a Companion Diagnostic for Pfizer’s BRAFTOVI in Combination With Cetuximab to Identify Patients With...

Foundation Medicine Inc., announced that it has received approval from the U.S. Food and Drug Administration for FoundationOne Liquid CDx to be used as...

Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration

Penumbra, Inc, a global healthcare company focused on innovative therapies, announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Bolt™ 7,...
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