Category: FDA Updates

FDA Updates

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FDA Clears Boston Scientific Insertable Cardiac Monitor

Boston Scientific has received 510(k) clearance from the U.S. FDA for the LUX-Dx Insertable Cardiac Monitor System, a device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation, cryptogenic stroke, and syncope.

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Clearances

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FDA OKs Medtronic Pediatric Hemodialysis System

The U.S. FDA has granted marketing authorization to Medtronic Inc. for the Carpediem System, which is indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 5.5 to 22 pounds.

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Draft Guidances

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FDA Takes Steps to Modernize 510(k) Medical Device Program

The U.S. FDA has announced that, as a first step toward implementation of the recently established Safety and Performance Based Pathway for medical devices, the agency is issuing draft guidances outlining the recommended premarket performance criteria and testing methodologies for four specific types of devices.