The Asia Pacific med-tech industry is expected to grow to $225 billion by 2030. Despite that rosy outlook, the landscape become increasingly challenging as med-tech investment saw a notable downturn since its peak in 2021, with venture financing and M&A deals decreasing by 22% and 37%, respectively, over the past two years.
The U.S. FDA’s newest draft guidance for dealing with medical product misinformation might seem to signal a cooperative attitude toward misinformation on the agency’s part, but regulatory attorney Daniel Kracov told BioWorld that the disincentives for doing so might still outweigh the incentives despite the reworked draft guidance.
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.