Medtronic's Micro Jewel II gets speedy clearance
This article was originally published in Clinica
Executive Summary
The US FDA has taken only two months to clear Medtronic's Micro Jewel II, an implantable cardioverter-defibrillator for patients of small stature. Medtronic says the FDA cleared its device relatively quickly because it recognises it as a "next generation" or an approved device. Micro Jewel II has a volume of 54cc, weighs 97g and delivers 30 joules of energy and can store 15 minutes of ECG data.