Videa Caries Assist is VideaHealth, Inc.’s AI software that marks suspected caries on dental radiographs for the dentist to review. The FDA cleared it in April 2022 for adult bitewings, and two later clearances, Videa Dental Assist (2023) and Videa Dental AI (2025), widen the same caries detection to periapicals and patients aged 3 and older, alongside other findings. VideaHealth doesn’t publish prices, and we found no published study with its own data on the product.
Quick verdict
Videa suits dental groups and DSOs that want an FDA-cleared second look at bitewings and periapicals, from a vendor that also sells notes, claims and analytics tools. The FDA record is the strongest evidence: four 510(k) clearances, and the three that cover caries each describe a reader study on radiographs from US sites. The weak spots are on the vendor side. Its saved pages don’t list supported imaging software or practice management systems, don’t mention a BAA, and give no prices.
Before you sign, ask VideaHealth which cleared device powers the product it now sells as Clinical Assist, whether it works with your image viewer and sensors, and whether it will sign a business associate agreement (BAA). Ask, too, for a demo on your own radiographs.
Videa Caries Assist at a glance
Videa Caries Assist was cleared as a cloud-based caries detection aid from VideaHealth, Inc. of Boston. The FDA has cleared four VideaHealth devices since 2022, three of which detect caries, and the most recent, Videa Dental AI (K251002), was cleared on September 19, 2025. Pricing is on request, and the vendor’s site doesn’t mention a BAA (checked October 19, 2026).
| Vendor | VideaHealth, Inc. (Boston, Massachusetts, per its FDA filings) |
|---|---|
| What it does | Marks suspected caries, and in later versions other findings, past treatments and anatomy, on dental radiographs for the dentist to review |
| Who it’s for | Dental practices and DSOs (the vendor’s site title); the vendor says 90,000+ clinicians use Videa |
| Pricing | Pricing on request (checked October 19, 2026) |
| FDA status | FDA 510(k) cleared: Videa Caries Assist, K213795 (April 21, 2022); most recent, Videa Dental AI, K251002 (September 19, 2025) |
| HIPAA / BAA | Not stated on the vendor’s site |
| Integrations | Not listed on the saved vendor pages. The FDA summaries say dentists reach it through their dental image viewer. |
| Data checked | October 19, 2026 |
What is Videa Caries Assist?
Videa Caries Assist is FDA-cleared software from VideaHealth that analyzes intraoral radiographs and draws boxes around suspected carious lesions. The dentist reviews each mark and makes the diagnosis. It was VideaHealth’s first caries clearance, and later Videa devices build on it.
VideaHealth’s 2022 FDA summary describes a cloud service reached through an API behind a firewalled network. From inside their dental viewer, the dentist uploads a bitewing and gets back either a clear statement that no carious lesions were found or a set of boxes that can be switched on and off. It covers active and secondary caries at all penetration depths, the summary says, on proximal, buccal/lingual, occlusal, root and cervical surfaces.
Since then, the name has changed on the vendor’s side. VideaHealth’s 2023 Videa Dental Assist summary calls that device “an expansion of the design input scope of Videa Caries Assist”, and Videa Dental AI (2025) lists Videa Dental Assist as its predicate. VideaHealth’s current site doesn’t use the Caries Assist name. It sells a product called Clinical Assist (“Move from detection to action quickly and confidently”) as part of a platform the vendor says has more than 8 products, but the pages we saved don’t say which cleared device sits behind it.
Key features
Videa’s caries features, as the FDA summaries describe them, are boxes or outlines around suspected lesions, a count of findings per image and a choice of two detection settings. The vendor’s site adds tools for notes, claims and practice analytics:
- Caries detection on bitewings (2022), then on bitewings and periapicals for patients aged 3 and older (2023 and 2025 clearances)
- Other suspected findings in the later versions, including calculus, periapical radiolucency, furcation, attrition, pulp stones and restorative imperfections
- Labels for past treatments, such as crowns, fillings, root canals and implants, and normal anatomy, which the FDA summaries say are not diagnostic aids
- Videa Dental AI (2025): a segmentation (outline) view for caries and calculus, and a toggle between a high sensitivity and a high specificity setting for caries and periapical radiolucency
- Videa Perio Assist: bone level measurements on bitewings and periapicals, shown as distances or percentages
- Voice Notes and Voice Perio: the vendor says these turn chairside talk into clinical notes and hands-free perio charting that writes back to your PMS; the Voice page asks you to join a waitlist
- Clean Claims and AutoVerify for claims and eligibility, and Daily Dashboard plus a separate analytics product for clinical coaching across providers and locations (vendor descriptions)
Videa Caries Assist vs. what an imaging AI tool should have
Videa Caries Assist meets the FDA side of our imaging checklist: cleared caries detection on bitewings and periapicals, pediatric use and dentist review built into the cleared use. The gaps are on the vendor’s pages, which name no supported imaging or PMS systems, no BAA and no prices.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance for each advertised finding | Partial | Caries detection is cleared; the saved vendor pages don’t say which cleared device powers Clinical Assist |
| Works with your imaging software | Partial | The FDA summaries say it is used through the dental image viewer; no list of supported viewers on the saved pages |
| Works with your practice management system | Not listed | Only Voice Perio is described as writing back to the PMS |
| Dentist reviews every finding | FDA listing | Cleared as a detection aid; the 2025 summary says it should not replace a dentist’s review of the image |
| Image types covered | FDA listing | Caries on bitewings and periapicals; panoramic images only for past treatments and anatomy |
| Data protection details | Not listed | The website privacy policy doesn’t mention HIPAA or a BAA |
Should have
| Feature | Status | Note |
|---|---|---|
| Published study that names the product | Not listed | One 2023 letter about Videa Perio Assist; no study with its own data |
| Patient-facing view for chairside explanations | Partial | The vendor says “When patients see what you see, they say yes to care” but doesn’t describe a patient view |
| Pediatric use covered | FDA listing | Caries on patients aged 3 and older (2023 and 2025 clearances) |
| Public pricing | Not listed |
Nice to have
| Feature | Status | Note |
|---|---|---|
| CBCT analysis | Not listed | |
| Insurance and claims support | Listed | Separate products: Clean Claims and AutoVerify |
| Practice analytics | Listed | Separate products: Daily Dashboard and a coaching analytics tool |
What the research says
No published study with its own data on Videa Caries Assist turned up in PubMed when we searched on October 19, 2026. It found one item naming a Videa product: a 2023 letter in Health Science Reports about Videa Perio Assist, which gives no figures or sample size. For test results, you have to go to VideaHealth’s own FDA submissions.
The 2023 letter. Written by authors at universities and colleges in Kenya, Pakistan and Ukraine, the correspondence discusses Videa Perio Assist, the bone level product. Its abstract says clinical testing showed high sensitivity and specificity but gives no numbers. It also calls the product’s FDA status an approval; the FDA’s database lists it as a 510(k) clearance, which is a different thing. None of the authors is listed as working for VideaHealth.
The 2022 FDA submission (Videa Caries Assist). The 510(k) summary, which VideaHealth prepared for the FDA, describes two tests. In a standalone test on 1,034 adult radiographs from 10 US sites, labeled by three US board-certified dentists, the software found caries with an image-based sensitivity of 70.8% and a positive predictive value of 59.5%. Results were lower on images from the Schick 33 sensor (a figure of merit of 0.608, against 0.740 overall); the summary adds that readers also scored lower on those images without the software, and improved with it (0.706 against 0.614). In a reader study of 226 adult radiographs from 10 US sites, 21 readers scored a figure of merit of 0.739 with the software and 0.667 without it, and every reader did better with it. The share of normal images with at least one false mark rose slightly with the software (0.33 against 0.29), a difference the summary calls not statistically significant.
The 2023 FDA submission (Videa Dental Assist). A reader study of 378 radiographs from over 25 US locations, with 26 readers, found a smaller caries gain: 0.024, or a 4.3% improvement in the figure of merit. The summary also says caries specificity was the only suspected finding that missed its standalone target, though it “performed well enough to still pass the clinical study”.
The 2025 FDA submission (Videa Dental AI). VideaHealth did not retrain the caries model, the summary says. It tested the new outline view and second detection setting with 20 readers on 378 radiographs from over 25 US locations, and the summary says readers improved on caries with either setting. In a separate standalone test on 1,445 radiographs from more than 35 US sites, caries specificity at the second setting was 0.867.
Keep in mind that these are company-run tests summarized for the FDA, not peer-reviewed studies. VideaHealth’s home page makes bigger claims: a 119% increase in caries detection, 20% higher case acceptance and 10% same-store growth. The page doesn’t say where those figures come from, and they don’t appear in the FDA summaries, so treat them as the vendor’s claims.
FDA status and privacy
The FDA’s 510(k) database lists four clearances for VideaHealth, Inc., three of them for caries detection. Each covers specific findings, image types and patient ages:
| Device | 510(k) | Cleared | What the FDA summary says it does |
|---|---|---|---|
| Videa Caries Assist | K213795 | April 21, 2022 | Identifies and localizes carious lesions on bitewings, for concurrent review by board licensed dentists, patients aged 22 and older |
| Videa Perio Assist | K223296 | February 6, 2023 | Aids dental professionals in measuring and visualizing mesial and distal bone levels on bitewings and periapicals |
| Videa Dental Assist | K232384 | December 15, 2023 | Identifies and localizes suspected findings including caries, plus past treatments and normal anatomy, on bitewing, periapical and panoramic radiographs, patients aged 3 and older |
| Videa Dental AI | K251002 | September 19, 2025 | Same indications as Videa Dental Assist, adding an outline view and a second detection setting |
The fine print narrows the newer clearances. The 2025 summary scopes caries to bitewings and periapicals for patients aged 3 and older, and says panoramic images are only for past treatments and anatomy, which are not diagnostic aids. It also says only dentists doing diagnostic work should use the suspected findings, and that the software should not be used in place of a full patient evaluation or relied on alone to make or confirm a diagnosis. AI marks are suggestions; the dentist decides what each one is. We found no PMA records for VideaHealth.
On privacy, the pages we saved say nothing about HIPAA, BAAs or security certifications. VideaHealth’s privacy policy, last edited October 12, 2025, covers its website and service, says the service is hosted in the United States, and doesn’t mention a business associate agreement. Ask for a BAA before you send patient radiographs.
Pricing
Pricing on request (checked October 19, 2026). VideaHealth’s pages ask you to book a demo.
Who it’s for
Videa fits a group practice or DSO that wants FDA-cleared caries marks on bitewings and periapicals, including for children, and may also want notes, claims or coaching tools from the same vendor. The testimonials on its site come mostly from clinical leaders at Heartland Dental, Gen4 Dental Partners, Independence Dental and 42 North, plus one dentist at One Manhattan Dental.
Look elsewhere, or ask more questions first, if you need CBCT analysis, published prices, or a written list of supported image viewers and PMS systems before a sales call. If you use a Schick 33 sensor, ask how the current version performs on it, since the 2022 test found lower standalone results on that sensor.
FAQ
Is Videa Caries Assist FDA cleared?
Yes. The FDA’s 510(k) database lists Videa Caries Assist as cleared on April 21, 2022 (K213795) for adult bitewings. Two later clearances, Videa Dental Assist (K232384, December 15, 2023) and Videa Dental AI (K251002, September 19, 2025), cover caries on bitewings and periapicals for patients aged 3 and older.
How much does Videa cost?
Pricing on request. VideaHealth doesn’t list prices on its site, which asks practices to book a demo (checked October 19, 2026).
How accurate is Videa Caries Assist?
No independent published study gives a figure. In VideaHealth’s 2022 FDA submission, the software had a 70.8% image-based sensitivity on 1,034 adult radiographs from 10 US sites, and 21 readers did better with it than without it. In the 2023 submission’s reader study (26 readers, 378 radiographs from over 25 US locations), readers’ caries figure of merit rose 4.3% (0.024) with the software.
Does Videa replace the dentist’s diagnosis?
No. The FDA summaries describe a detection aid, and the 2025 summary says it should not replace a dentist’s review of the image or be relied on alone to make or confirm a diagnosis. The dentist decides on every finding.
Which imaging software does Videa work with?
The saved vendor pages don’t list supported systems. The FDA summaries say dentists use it through their dental image viewer, and the test images came from sensors by AirTechniques, Carestream, Dexis, Gendex, Kavo and Schick, among others. Ask VideaHealth to confirm your viewer and sensor.
Does VideaHealth sign a BAA?
The vendor’s site doesn’t say. Its privacy policy covers the website and service and doesn’t mention HIPAA or a business associate agreement, so ask for one in writing before you connect patient images.
How this review was put together
We didn’t use Videa ourselves. This review is built from VideaHealth’s home, platform, Voice and analytics pages and its privacy policy, the FDA’s 510(k) and PMA databases and the four 510(k) decision documents, and a PubMed search. User reviews were not collected for this review. All sources were checked on October 19, 2026.
Sources
- Videa: home page, accessed October 19, 2026
- Videa: Our Platform page, accessed October 19, 2026
- Videa: Voice Notes page, accessed October 19, 2026
- Videa: coaching analytics page, accessed October 19, 2026
- Videa: Privacy Policy, accessed October 19, 2026
- FDA 510(k) K213795, Videa Caries Assist, accessed October 19, 2026
- FDA 510(k) K223296, Videa Perio Assist, accessed October 19, 2026
- FDA 510(k) K232384, Videa Dental Assist, accessed October 19, 2026
- FDA 510(k) K251002, Videa Dental AI, accessed October 19, 2026
- openFDA device 510(k) and PMA databases (search of VideaHealth), accessed October 19, 2026
- Celebrating breakthrough in dental diagnostics … Videa Perio Assist: A correspondence, Health Science Reports (2023), accessed October 19, 2026
