MANUFACTURING PROCESS FOR MEDTRONIC DEVICE ADEQUATE, FDA FINDS

After looking into charges by a former Medtronic employee that the firm had overlooked safety issues regarding one of its heart devices, the FDA has reportedly found nothing to indicate the product is unsafe.

The employee, a Medtronic engineer, had apparently expressed concerns about the wireless monitoring capabilities of the Concerto implantable defibrillator, namely, whether the device had been properly tested before it was released onto the market. The device was approved by the FDA last year.