VELMENI Receives FDA Clearance

 

VELMENI has announced that it has received FDA 510(k) clearance for VELMENI for DENTISTS, an innovative AI that analyzes and annotates dental X-rays.

VELMENI for DENTISTS (V4D) assists dentists in detecting dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older.

VELMENI is the first dental AI approved by the FDA to detect pathologies in panoramic X-rays. VELMENI for DENTISTS adds its US FDA clearance to existing Canadian MDEL and New Zealand MEDSAFE clearances.

VELMENI for DENTISTS’s AI-driven computer-aided clinical radiology solution is available to dentists throughout North America, Canada, and many other parts of the world.

VELMENI collaborated closely with over 50 dentists, clinical members of VELMENI’s dental board, and 1,300 dentists participating in a beta program that provided valuable feedback. Over 90% of dentists agreed that VELMENI’s AI technology could be very helpful and said they would adopt it in their dental practice.

“Finally, I have an AI that works with panoramic radiographs,” said Pedram Eli Mastour, DDS, former assistant professor at USC & Private Practice CA.

VELMENI-PAN-Findings

Many dental conditions are difficult to see in X-rays. The VELMENI AI reveals numerous pathologies, increasing diagnostic accuracy.

“As a follower of the latest advances in digital dentistry, I’m keeping my eye on VELMENI,” said Ed Zuckerberg, DDS, renowned dentist & key advisor to VELMENI.

Each finding is evaluated and accepted or rejected by the dentist to ensure that diagnoses and treatment decisions are made by a human dental expert.

Because of VELMENI’s “crowdsourced” design, every time a dentist accepts or rejects the AI’s findings, that real-world data contributes to future releases, making the product smarter and more accurate for everyone.

VELMENI is pioneering new developments in the analysis of 3D/CBCT scans, virtual reality, immersive patient education, and more. Our ultimate goal is to bring quality dental care to a billion underserved patients around the world.

“VELMENI creates innovative technologies that impact patients, dentists, and the world,” said Mini Suri, CEO of VELMENI.

VELMENI is a global leader in dental artificial intelligence, helping both payers and providers improve patient care. VELMENI’s AI integrates with existing practice management and dental imaging software to help dentists deliver high-quality care, improve patient acceptance, and automate administrative tasks.

VELMENI thanks all those who believed in our product and invested their time and financial resources to make this dream a reality.

Visit www.velmeni.ai for more information.