First wave of AI radiology clearances (2018-2019)
The FDA cleared dozens of AI-based radiology tools, but they were locked. Any algorithm change required a new submission, and companies had to file new 510(k)s for even minor updates.
Companies faced high costs for improving their algorithms post-market.
This created a disincentive to update AI models, making them stale over time.
The PCCP in Heartvue.Proton's clearance directly addresses this limitation, allowing controlled algorithm evolution.
