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SurGenTech Bone Marrow Aspirate Kit Cleared

[ Price : $8.95]

FDA clears a SurGenTec 510(k) for its proprietary B-MAN Bone Marrow Aspirate Kit.

Class 1 Recall of ClotTriever XL

[ Price : $8.95]

Inari Medical begins a Class 1 recall to update the use instructions for its ClotTriever XL catheter after discovering serious adv...

FDA Clears Hydros Robotic System

[ Price : $8.95]

FDA clears Procept BioRobotics Hydros Robotic System used for aquablation therapy in patients with benign prostatic hyperplasia.

Bumpus Refuses to Approve Intarcia NDA

[ Price : $8.95]

FDA principal deputy commissioner Namandj Bumpus says CDER correctly denied approval of a 2016 Intarcia NDA for ITCA 650 to treat ...

Panel to Mull Stomach/Esophagus Cancer Therapies

[ Price : $8.95]

Federal Register notice: FDA announces a 9/26 Oncologic Drugs Advisory Committee meeting to discuss the use of immune checkpoint i...

Guide on Device Change Control Plans

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Federal Register notice: FDA makes available a draft guidance entitled Predetermined Change Control Plans for Medical Devices.

FDA OKs Updated Covid Vaccines

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FDA approves and issues an emergency use authorization for Moderna and Pfizer Covid-19 updated mRNA vaccines targeting the most pr...

Defibtech Recalls Chest Compression Device

[ Price : $8.95]

Defibtech begins a Class 1 recall of its RMU-2000 ARM XR Chest Compression Devices due to a motor problem that may cause them to s...

Wex Pharma Gets Fast Track for Pain Drug

[ Price : $8.95]

FDA gives Wex Pharmaceuticals a fast-track designation for Halneuron (tetrodotoxin for injection), an alternative to narcotics and...

FDA Publishes 68 New, Revised Product-Specific Guides

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FDA publishes 68 new and revised product-specific guidances to aid in generic drug development.