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FDA Endorses Vaporized Hydrogen Peroxide

[ Price : $8.95]

FDA endorses vaporized hydrogen peroxide to be an established sterilization method for medical devices.

Info Collection on Drug Expedited Programs

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Federal Register notice: FDA seeks comments on an information collection extension entitled Expedited Programs for Serious Conditi...

Megadyne Recalls Patient Return Electrodes

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Megadyne Medical Product recalls its Mega Soft Universal Patient Return Electrodes to update its Instructions for Use and product ...

Cabaletta Bio Gains Fast Track on CABA-201

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FDA grants Cabaletta Bio a fast track designation for CABA-201, an investigational 4-1BB-containing CD19-CAR T cell therapy.

Endotronic Files PMA for Home Heart Monitor

[ Price : $8.95]

Endotronix files a PMA for the Cordella Pulmonary Artery (PA) Sensor System, a heart failure patient management platform for home ...

Omnipod 5 Insulin Pump Calculator Recalled

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Insulet Corp. recalls its Omnipod 5 smartphone application and software that is used to control an insulin pump due to an error in...

FDA Approves Florida Drug Importation

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FDA authorizes Floridas importation program that will allow drugs to be imported from Canada as long as certain conditions are met...

Nanowear Wearable Diagnostic Cleared

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FDA clears a Nanowear 510(k) for the companys SimpleSense, a nanotechnology-enabled wearable and software platform.

Novartis Radioligand Manufacturing Site Approved

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FDA approves Novartis Radioligand Therapy manufacturing facility in Indianapolis, IN, to produce prostate cancer therapy Pluvicto....