Medtronic one of the world’s leading medical device companies, has been hit by a warning letter from the regulatory Food and Drug Administration (FDA) in America which could delay the launch of the company’s new MiniMed 780G insulin pump.
The FDA criticised Medtronic’s procedures for product recalls, complaint handling, quality systems and risk assessment following an inspection of the diabetes group headquarters in California last July. Six months on no meeting has been organised with Medtronic executives to agree the steps required to rectify the identified problems. Meanwhile Medtronic is not recommending any action by doctors or patients as a result of the warning letter.
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