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January 4, 2024

VideaHealth Achieves Landmark FDA Clearance for 30+ Dental Conditions: Here’s what you need to know

VideaHealth announces FDA clearance for Videa Dental Assist on VideaAI. Covering the majority of dental conditions and introducing the first FDA-cleared pediatric dental AI for patients aged 3 and up, VideaAI sets the standard in dental diagnostics.

VideaHealth recently announced a groundbreaking achievement—Videa Dental Assist (VDA), making it the largest FDA clearance in dental AI and the first in pediatric dental AI. This milestone isn't just significant for VideaHealth; it's a pivotal moment in dentistry, carrying profound implications for dental technology advancement and patient care on a broader scale.

Securing FDA clearance highlights VideaHealth’s rigorous adherence to stringent regulatory standards, affirming its safety, effectiveness, and reliability. This milestone marks a watershed moment, paving the way for future advancements in AI-driven dental technology and instilling confidence in practitioners and patients regarding VideaAI's transformative potential and credibility within the broader healthcare landscape.

What is the new FDA clearance?

Videa Dental Assist (VDA) is a collection of AI models on VideaAI cleared by the FDA that is made up of 30+ dental detections. With the addition of these dental detections, VideaAI redefines AI in dentistry by offering extensive pathology detection suites covering major treatments like caries, periodontal concerns, and endodontic lesions. Additionally, VideaAI introduces the world's first dental pediatric AI for patients aged three and up, providing unmatched precision and consistency in annotations for pediatric cases and offering insights into subtle diseases across all age groups.

Validated by dental experts, VDA features millions of annotations by 100+ clinical experts, resulting in improved pathology detection by 100% of dentists across various pathologies.

What is included in this new FDA clearance?

VDA covers many dental detections that will make their way into the VideaAI platform. Some of those dental detections include potential: 

  • Carious lesion detection on ALL primary and secondary teeth: Providers can use VideaAI to help diagnose all patients regardless of age. 
  • Carious lesion detection on periapical x-rays: providers can diagnose potential caries on all teeth, particularly anterior teeth, using PAs.
  • Periapical radiolucency detection or PRL:  Providers to use VideaAI to more effectively identify signs of infection, monitor the progress of apex concerns, or identify cysts.
  • Calculus detection: providers can use VideaAI to educate patients and influence the treatment and need for Scaling and Root Planing or other periodontal procedures. This, combined with our Radiographic Bone Level model, paints a picture of disease prognosis for the patient and the clinician. 
  • Existing restorative concerns: With VideaAI, providers can better differentiate caries from existing restorative concerns, like open margins.
  • Other concerns like furcation, widened PDL, attrition, broken and chipped teeth, pulp stones, and dens invaginatus: providers can use VideaAI beyond periodontal and caries diagnosis. 

To see the complete FDA clearance, click here. 

Understanding FDA Clearance and Its Significance

FDA clearance is a regulatory milestone indicating that a product has undergone evaluation and approval for a specific use within the FDA's guidelines. For medical devices and technologies, this clearance ensures safety, efficacy, and quality, meeting the necessary standards for clinical use.

VideaHealth's clearance encompasses a sophisticated artificial intelligence system to analyze medical imaging or aid dental providers in diagnosis and treatment planning. Such advancements can streamline processes, enhance accuracy, and improve patient outcomes.

The FDA confirmed Videa Dental Assist, granting clearance for 10 clinical pathologies and 25 dental detections, securing the largest AI FDA clearance in radiology/x-ray. This achievement is a testament to VideaHealth’s dedication to quality and innovation.

Impact and Implications of FDA Clearance

The impact of FDA clearance from VideaHealth extends beyond the company itself, significantly benefitting healthcare providers, practitioners, and patients. Providers gain access to cutting-edge technology to augment their decision-making processes, leading to more accurate diagnoses and personalized treatments. VideaAI plays a role in early detection, empowering dentists to identify small lesions across patients and image types, simplifying treatments, and enhancing patient care.

Patients can anticipate improved dental healthcare experiences. Earlier and more precise diagnoses could mean faster treatment initiation, potentially leading to better prognoses and overall outcomes. Ultimately, FDA clearance for innovative technologies like those developed by VideaHealth sets a higher standard for patient care and signifies a leap forward in healthcare innovation.

Why FDA Clearance Matters

FDA clearance is more than a stamp of approval; it symbolizes a commitment to ensuring the safety and effectiveness of medical technologies. The rigorous evaluation processes these innovations undergo fosters trust among healthcare providers and patients, setting high standards for quality.

One standout with this clearance is VideaHealth's commitment to making the most sensitive AI on the market. The importance of catching things early and making the most comprehensive AI was important enough to VideaHealth that they improved the original caries model. This ensures world-class AI and makes VideaHealth the only dental AI company to spend the time and money to retest and improve models. 

Moreover, this clearance opens doors for further advancements and collaborations in the dental space. It encourages investment and innovation, leading to continuous improvement and the development of more groundbreaking solutions to address dentistry challenges.

VideaHealth's attainment of FDA clearance is a significant achievement in dental technology, representing a step forward in harnessing AI's power to revolutionize patient care and medical diagnostics.

How can you get involved?

No matter your role in a dental practice or DSO, you can instantly discover the benefits of VideaAI. VideaAI has proven to be easy to onboard and get going quickly. There’s no better time than the present to see what AI can do for you.

For more information on VideaAI and how VideaHealth can help your practice or Dental Service Organization, schedule a time to meet with one of our team members.

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