Medtech approvals stagnate

At the halfway point of 2022 there was hope that the FDA’s efforts to increase throughput might lead to an uptick in medical device approvals. However, this optimistic scenario did not play out, and the 46 green lights last year represented the lowest total since 2013.

These approvals also took a relatively long time to come through – although the regulator picked up speed in the second half of the year. With medtech M&A and IPOs faltering amid a broader market malaise, a pick-up in approval numbers will be needed to convince investors of the underlying health of the sector.