Abiomed Letter Underscores Questions On FDA’s Clinical Decision Support Guidance
A warning letter from the US FDA to device manufacturer Abiomed highlights industry’s criticism that the agency’s final guidance on clinical decision support software is flawed and oversteps regulatory boundaries.
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This week, Abiomed announced a class I recall of Impella heart pumps; the FDA released new device sterilization standards; and Boston Scientific planned a $140m new campus in Minnesota.
Johnson & Johnson plans to buy Abiomed for $380 per share – about $16.6bn in total – plus up to $35 per share in potential commercial and clinical milestone-contingent payments. Abiomed is the clear leader in percutaneous circulatory support technology, but would benefit from J&J's reach and resources while complementing J&J's Biosense Webster electrophysiology business.
Businesses should reevaluate the classification of their clinical decision software based on a new FDA guidance, Kyle Faget of Foley & Lardner LLP tells Medtech Insight.