Second Opinion is the first chairside radiologic detection aid to receive FDA clearance

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On March 4th, Pearl – the dental AI company that I spun out of GumGum in 2019 – received FDA clearance for Second Opinion, our software that automatically reads dental x-rays to give dentists real-time radiologic assistance when diagnosing patients. It was a banner day for Pearl, and it validated my decision to venture away from the familiar seas of adtech into the great dental ocean.

Key Takeaways
  • FDA clearance indicates that scientific evaluation has determined a product to be safe and effective and its claims to be accurate.
  • Second Opinion's FDA clearance acknowledges its ability to recognize many types of dental pathology, not just caries.
  • Second Opinion is the first and only product of its kind that can deliver real-time, easily understandable, chairside detection of a wide range of dental conditions.

 

A significant achievement

We had already received similar approvals from a number of foreign authorities, including those of Canada, Australia, New Zealand, the EU and the UAE. Those came more quickly, because the principal concern of overseas regulators is risk to the patient. The FDA’s time-consuming and rigorously scientific scrutiny assesses not only the safety of a product but also its efficacy and the accuracy of claims made for it. Obviously the FDA's clearance is particularly significant to an American company, but it also sends a globally recognized signal.

At Pearl we had already conducted several studies to demonstrate that computer vision was at least on a par with human radiologists in detecting tooth decay in x-ray images. Second Opinion detects much more than just decay, however. It recognizes a host of conditions most people have never heard of, and, given the FDA’s high clinical standards, getting clearance required a new order of complexity and completeness in testing. Four separate studies, each involving thousands of x-rays and over 80 expert dentists and radiologists, produced over 4000 pages of data and analysis.

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Pearl Second Opinion screens

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The findings were clear: Dentists who use Second Opinion read radiographs more accurately and sensitively than dentists who don’t.

A unique distinction

Second Opinion is now the first and only product of its kind that is able to deliver immediate chairside detection for a wide range of dental conditions to dentist and patient alike, in real time and in a readily understandable form.

FDA clearance for Second Opinion is obviously a milestone for us, but I believe its importance goes further. Specialized AI applications already exist in a number of medical fields; for instance, oncologists use AI-trained computer vision tools to identify lung neoplasms. But comparatively few people – luckily – encounter those applications. Dental x-rays, on the other hand, are part of everyone’s life. As it becomes increasingly widely adopted, Second Opinion will become most people’s introduction to the medical benefits of AI, which include both high sensitivity to subtle indicators and exceptional consistency.section-3

Just the beginning

Regular encounters with AI at the dentist will normalize the AI-enabled healthcare experience and stimulate patient demand for the technology across the healthcare continuum––from emergency medicine to routine checkups. Nothing drives innovation like demand. So as March 4th marked the true start of dentistry’s AI revolution, I believe that time will show that it also marked a point of inflection along the exponential curve of medical progress writ large.

For now, however, I’m just immensely proud to be with the team responsible for introducing AI’s transformative force to the progress of dental medicine. When the FDA cleared Second Opinion, it cleared the path to dental patient confidence, consistent diagnoses, a higher standard of care and, ultimately, better oral healthcare outcomes for patients around the world.