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Panel to Meet on Barricaid Anular Closure Device

[ Price : $8.95]

Federal Register notice: FDA announces a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committ...

FDA Clears a TransEnterix Robot Surgical System

[ Price : $8.95]

FDA clears a TransEnterix Surgical 510(k) for the Senhance System, a new robotically-assisted surgical device (RASD) for use in mi...

FDA Accepts Prometic BLA for Ryplazim

[ Price : $8.95]

FDA accepts a Prometic BLA for Ryplazim (plasminogen), indicated for treating plasminogen deficiency.

Draft Guide on Assessing Drug User Fees

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance on Assessing User Fees Under the Prescription Drug User Fee Amendmen...

FDA Expediting Reviews/Approvals to Prevent Shortages After Hurricanes

[ Price : $8.95]

Commissioner Scott Gottlieb says FDA has been expediting reviews and approvals of different dosage forms and generic versions of p...

NuVasive Cleared Expanded 510(k) for Precice System

[ Price : $8.95]

FDA clears a NuVasive 510(k) for an expanded use of its Precice system to now include open and closed fracture fixation, pseudoart...

FDA Clears Siemens 7T MRI Device

[ Price : $8.95]

FDA clears a Siemens Medical Solutions 510(k) for the first seven-tesla magnetic resonance imaging device, Magnetom Terra, which m...

FDA Updates Least Burdensome Guidance

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Attorney Adrienne Lenz reviews new FDA guidance on the least burdensome requirement for medical device deficiency letter.

Panel Backs Sparks Gene Therapy for Vision Loss

[ Price : $8.95]

FDA's Cellular, Tissue and Gene Therapies Advisory Committee votes unanimously (16 to 0) to recommend approval for a Spark Therape...

Cranial Motion Measurement Devices Require 510(k): Correction

[ Price : $8.95]

Federal Register notice: FDA corrects a final order entitled Medical Devices; Neurological Devices; Classification of Cranial Moti...