Just as the debate over whether AI might replace radiologists is starting to fade away, Oxipit’s ChestLink solution became the first regulatory-approved imaging AI product intended to perform diagnoses without involving radiologists (*please see editor’s note below regarding Behold.ai). That’s a big and potentially controversial milestone in the evolution of imaging AI and it’s worth a deeper look.
About ChestLink – ChestLink autonomously identifies CXRs without abnormalities and produces final reports for each of these “normal” exams, automating 15% to 40% of reporting workflows.
Automation Evidence – Oxipit has already piloted ChestLink in supervised settings for over a year, processing over 500k real-world CXRs with 99% sensitivity and no clinically relevant errors.
The Rollout – With its CE Class IIb Mark finalized, Oxipit is now planning to roll out ChestLink across Europe and begin “fully autonomous” operation by early 2023. Oxipit specifically mentioned primary care settings (many normal CXRs) and large-scale screening projects (high volumes, many normal scans) in its announcement, but ChestLink doesn’t appear limited to those use cases.
ChestLink’s ability to address radiologist shortages and reduce labor costs seem like strong and unique advantages. However, radiology’s first regulatory approved autonomous AI solution might face even stronger challenges:
- ChestLink’s CE Mark doesn’t account for country-specific regulations around autonomous diagnostic reporting (e.g. the UK requires “appropriate reporting” with ionizing radiation-based exams)
- Radiologist societies historically push back against anything that might undermine radiologists’ clinical roles, earning potential, and future career stability
- Health systems’ evidence requirements for any autonomous AI tools would likely be extremely high, and they might expect similarly high economic ROI in order to justify the associated diagnostic or reputational risks
- Even the comments in Oxipit’s LinkedIn announcement had a much more skeptical tone than we typically see with regulatory approval announcements
Autonomous AI products like ChestLink could address some of radiology’s greatest problems (radiologist overwork, staffing shortages, volume growth, low access in developing countries) and their economic value proposition is far stronger than most other diagnostic AI products.
However, autonomous AI solutions could also face more obstacles than any other imaging AI products we’ve seen so far, suggesting that it would take a combination of excellent clinical performance and major changes in healthcare policies/philosophies in order for autonomous AI to reach mainstream adoption.
*Editor’s Note – April 21, 2022: Behold.ai insists that it is the first imaging AI company to receive regulatory approval for autonomous AI. Its product is used with radiologist involvement and local UK guidelines require that radiologists read exams that use ionizing radiation. All above analysis regarding the possibilities and challenges of autonomous AI applies to any autonomous AI vendor in the current AI environment, including both Oxipit and Behold.ai.