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Medtronic IDs Gene Causing Abnormal Heart Rhythms

[ Price : $8.95]

Medtronic says two studies have identified a gene associated with life-threatening abnormal heart rhythms. The studies evaluated g...

QS, MDR Issues Found at Cardiac Designs

[ Price : $8.95]

FDAs Dallas District Office warns Cardiac Designs about Quality System and Medical Device Reporting violations in its manufacturin...

Hartley Medical Center Pharmacy Cited

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A just-released FDA-483 details six observations from an inspection at the Hartley Medical Center pharmacy.

Appeals Court Ups Cybersecurity Litigation Risk

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Attorney Alexis Kellert says that a recent Third Circuit Appeals Court decision bolstered the Federal Trade Commissions role in ac...

New FDA Export Certificate Fees Out

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FDA announces revised fees and a new formula for calculating medical device export certificates.

Pacific Vision Laser Ad Omits Risk Info: FDA

[ Price : $8.95]

FDA warns Pacific Vision about violative promotional materials for its WaveLight EX500 excimer laser used for LASIK procedures.

Zeiss Medical 510(k) Cleared for AngioPlex OCT

[ Price : $8.95]

FDA clears a Zeiss Medical Technology 510(k) for its AngioPlex Optical Coherence Tomography Angiography System for assessing blood...

FDA Clears Surefire Medical Surefire Precision Device

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FDA clears a Surefire Medical 510(k) for the Surefire Precision, an advanced infusion technology with an expandable tip to increas...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cardiac Designs, Flextronics International, Pacific Vision, and Rapid Diagnostic...

BMS/AbbVie BLA for Multiple Myeloma Accepted by FDA

[ Price : $8.95]

FDA accepts for priority review a Bristol-Myers Squibb and AbbVie BLA for Empliciti (elotuzumab), indicated for treating multiple ...