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Megadyne Mega Soft Electrode Recall is Class 1

[ Price : $8.95]

FDA says the Megadyne recall of four models of patient return electrodes following reports of patient burns is Class 1.

GAO Probing FDA Ventilator Recall Actions

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The Pittsburgh Post-Gazette says GAO has accepted a request from two senators to look into FDA oversight of medical device adverse...

Reducing the Potential for Pulse Oximeter Bias

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Two stakeholders raise concerns about an FDA discussion paper on guidelines for pulse oximeters that consider skin pigmentation, r...

FDA Needs Help in Regulating Algorithms: Califf

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FDA commissioner Robert Califf says FDA needs to work within a community of organizations assessing and evaluating artificial inte...

DermaSensor AI Skin Cancer Detector Cleared

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FDA clears DermaSensor's real-time, skin cancer evaluation system.

FDA Extends Narcan Shelf Life

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FDA extends the shelf life of Emergent BioSolutions newly manufactured Narcan (naloxone HCl) 4 mg nasal spray products from three ...

Reschedule Marijuana to Schedule 3: FDA

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FDA recommends that the Drug Enforcement Administration down-classify marijuana from Schedule 1 to Schedule 3 under the Controlled...

Nurix Therapeutics Gets Fast Track Status

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FDA grants Nurix Therapeutics a fast track designation for NX-5948 for treating certain adult patients with relapsed or refractory...

Info Collection on New Dietary Ingredients

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Federal Register notice: FDA revises an information collection entitled Premarket Notification for a New Dietary Ingredient (NDI) ...

Multiple Violations at Dr. Joel Kaplan Inc.

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FDA warns San Diego, CA-based Dr. Joel Kaplan Inc. about multiple violations in its manufacturing and distribution of several devi...