Dental Startup Pearl Gets FDA Clearance for AI-Powered X-Ray Platform

Keerthi Vedantam

Keerthi Vedantam is a bioscience reporter at dot.LA. She cut her teeth covering everything from cloud computing to 5G in San Francisco and Seattle. Before she covered tech, Keerthi reported on tribal lands and congressional policy in Washington, D.C. Connect with her on Twitter, Clubhouse (@keerthivedantam) or Signal at 408-470-0776.

​Dental startup Pearl uses its x-rays to show teeth.
Courtesy of Pearl

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A West Hollywood-based startup has received Food and Drug Administration clearance for what it calls the first artificial intelligence-enabled product that can read dental x-rays and identify cavities, plaque and other dental conditions.

Second Opinion is an AI detection platform created by Pearl, a dentistry startup founded in 2019 to leverage machine learning and AI to help dentists detect problems in otherwise healthy teeth. The startup raised $11 million in Series A funding in 2019 from Craft Ventures and Santa Monica-based Crosscut Ventures.


To develop Second Opinion, Pearl gathered over 100 million dental x-rays from dental practices and academic institutions. The AI platform points out discrepancies found in an x-ray and also serves as a patient communication tool, allowing dentists to show different models of a patient’s teeth and point out problem areas.

“I do think that this is going to become very fundamental to the category [of dentistry] very quickly, and therefore will actually serve as a model for the rest of medicine—for how to infuse and deploy a AI widely at scale, with the ultimate benefit and potential of really elevating the standard of care in a provable way,” Pearl founder and CEO Ophir Tanz told dot.LA.

Pearl\u2019s AI program examine teeth.Pearl’s AI program examine teeth.Courtesy of Pearl

The FDA’s clearance comes amid ongoing skepticism from some within the medical community about the effectiveness of AI applications. A presentation made by the American College of Radiology to the FDA in 2020 reported that 95% of clinicians thought AI was too inconsistent or inaccurate to be used by medical practices. Though the FDA is the largest regulatory body in health care, it has no consistent framework for signing off on a piece of AI that can guide diagnostics, such as the number of reference images used, the diversity of its dataset or its accuracy rate. This has slowed down the clinical adoption rate of such technologies—and while the FDA has proposed a framework to address some of these challenges, nothing has been implemented yet.

Second Opinion’s journey to receiving FDA clearance involved a multi-year process to test every single use case that the platform is trained to do—such as identifying tooth decay, plaque, bone lesions around a tooth and a handful of other discrepancies in otherwise-healthy teeth. Receiving FDA clearance entails a separate and different process than receiving FDA approval; while the former indicates that a product is as good as existing alternatives already on the market, the latter requires a different set of processes for more novel or riskier products to prove that their benefits outweigh potential drawbacks. Tanz noted that the FDA sought only clearance for Second Opinion, and neither required nor asked for approval to allow the product to be marketed in the U.S.

A patient goes under the lights in the dentist\u2019s office.A patient goes under the lights in the dentist’s office.Courtesy of Pearl

Though some critics claim that AI can’t pick up on certain nuances that a human dentist might, Pearl contends that those critics often fail to account for the counter-argument of human error. Through the nonprofit Dental AI Council, the startup commissioned a study that found when presenting a panel of 136 dentists with an X-ray to review, roughly half of them found a cavity, while the other half found none.

Tanz said he is not interested in expanding Pearl’s services into radiology at large, and acknowledged that bottlenecks in the FDA process make it harder to develop, clear and adopt similar technology. Already, the startup has received regulatory approvals from Canada, Australia, the U.K., the European Union and the United Arab Emirates, and is working with roughly 4,000 dental organizations and radiograph manufacturers.

“We think of this as a utility, kind of like water or power,” Tanz said. “You're not going to have any dental practice where this is not going to be powering the radiographic side of things… We really do believe that this will be integrated into every practice in the world in a relatively short period of time.”

Update, March 10: This article has been updated to clarify the difference between FDA clearance and FDA approval, and to specify that Pearl's Second Opinion product did not require FDA approval to be marketed in the U.S.

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LA Tech ‘Moves’: LeaseLock, Visgenx, PlayVS and Pressed Juicery Gains New CEOs

Decerry Donato

Decerry Donato is a reporter at dot.LA. Prior to that, she was an editorial fellow at the company. Decerry received her bachelor's degree in literary journalism from the University of California, Irvine. She continues to write stories to inform the community about issues or events that take place in the L.A. area. On the weekends, she can be found hiking in the Angeles National forest or sifting through racks at your local thrift store.

LA Tech ‘Moves’: LeaseLock, Visgenx, PlayVS and Pressed Juicery Gains New CEOs
LA Tech ‘Moves’:

“Moves,” our roundup of job changes in L.A. tech, is presented by Interchange.LA, dot.LA's recruiting and career platform connecting Southern California's most exciting companies with top tech talent. Create a free Interchange.LA profile here—and if you're looking for ways to supercharge your recruiting efforts, find out more about Interchange.LA's white-glove recruiting service by emailing Sharmineh O’Farrill Lewis (sharmineh@dot.la). Please send job changes and personnel moves to moves@dot.la.

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LeaseLock, a lease insurance and financial technology provider for the rental housing industry named Janine Steiner Jovanovic as chief executive officer. Prior to this role, Steiner Jovanovic served as the former EVP of Asset Optimization at RealPage.

Esports platform PlayVS hired EverFi co-founder and seasoned business leader Jon Chapman as the company’s chief executive officer.

Biotechnology company Visgenx appointed William Pedranti, J.D. as chief executive officer. Before joining, Mr. Pedranti was a partner with PENG Life Science Ventures.

Pressed Juicery, the leading cold-pressed juice and functional wellness brand welcomed Justin Nedelman as chief executive officer. His prior roles include chief real estate officer of FAT Brands Inc. and co-founder of Eureka! Restaurant Group.

Michael G. Vicari joined liquid biopsy company Nucleix as chief commercial officer. Vicari served as senior vice president of Sales at GRAIL, Inc.

Full-service performance marketing agency Allied Global Marketing promoted Erin Corbett to executive vice president of global partnership and marketing. Prior to joining Allied, Corbett's experience included senior marketing roles at Disney, Warner Bros. Studios, Harrah's Entertainment and Imagi Animation Studios.

Nuvve, a vehicle-to-grid technology company tapped student transportation and automotive sales and marketing executive David Bercik to lead the K-12 student transportation division.

This Week in ‘Raises’: Curri Scoops Up $42M, Mosaic Scores $26M

Decerry Donato

Decerry Donato is a reporter at dot.LA. Prior to that, she was an editorial fellow at the company. Decerry received her bachelor's degree in literary journalism from the University of California, Irvine. She continues to write stories to inform the community about issues or events that take place in the L.A. area. On the weekends, she can be found hiking in the Angeles National forest or sifting through racks at your local thrift store.

Raises
Image by Joshua Letona

A local logistics platform raised fresh funding to put toward product development, infrastructure and sales and marketing initiatives, while a San Diego-based fintech company closed its Series C funding round to expand its investment in AI which will empower high-growth SMB and mid-market finance leaders.

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Venture Capital

Curri, a Ventura-based logistics platform, raised a $42 million Series B funding round led by Bessemer Venture Partners.

San Diego-based financial platform Mosaic raised a $26 million Series C funding round led by OMERS Ventures.

AHARA, a Los Angeles-based startup focused on providing personalized nutrition suggestions, raised a $10.25 million seed funding round led by Greycroft.

Per an SEC filing, San Diego-based developer of peptide therapeutics designed to assist in the treatment of autoimmune diseases and disorders selectIon raised $5 million in funding.

Miscellaneous

Los Angeles-based Sensydia, a company working on non-invasive cardiac diagnostics, said this morning that it has received $3 million in a NIH grant.

Raises is dot.LA’s weekly feature highlighting venture capital funding news across Southern California’s tech and startup ecosystem. Please send fundraising news to Decerry Donato (decerrydonato@dot.la).

'Esports Winter’ is a Myth, Local Gaming Execs Say

Samson Amore

Samson Amore is a reporter for dot.LA. He holds a degree in journalism from Emerson College. Send tips or pitches to samsonamore@dot.la and find him on Twitter @Samsonamore.

'Esports Winter’ is a Myth, Local Gaming Execs Say
Samson Amore

Last year, global venture capital investment in esports dropped by more than 40%. Investors have been rapidly selling off teams and franchises, and the industry has witnessed a consistent decline in ad spend. This has prompted many critics to coin the term “esports winter,” referring to a fall-off in the industry, an indication that VCs believe their investments didn’t achieve success as expected.

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