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FDA Approves Expanded Labeling of Medtronic MRI Leads

Interstom labelling expansion approved

Medtronic plc says it has received approval from the U.S. FDA for expanded MRI labeling of its InterStim™ II and InterStim™ … continue reading “FDA Approves Expanded Labeling of Medtronic MRI Leads”

FDA Clearances Enhance Mazor™ Robotic Guidance System

The U.S. FDA has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated

FDA OKs ReCor Paradise™ Ultrasound Renal Denervation

ReCor Medical’s Paradise™ Ultrasound Renal Denervation System has received Breakthrough Device Designation from the U.S. FDA for the treatment of patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications.

Carpediem™ First Cardio-Renal Pediatric Dialysis Launch

Carpediem is the first and only pediatric cardio-renal dialysis machine

Medtronic plc has announced the U.S. commercial launch of the Carpediem™ Cardio-Renal Pediatric Dialysis Emergency Machine, the first and only … continue reading “Carpediem™ First Cardio-Renal Pediatric Dialysis Launch”

U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel

Next-generation Hydrogel spacer offers enhanced visibility via CT Scan to optimize treatment planning for patients undergoing radiation for prostate cancer. … continue reading “U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel”

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