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Adravision Receives FDA Clearance for its Adravision Perio Device



Atlanta - Adravision, a global leader in dental artificial intelligence, has announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to sell its Adravision Perio product to dental practices.

 

With the FDA’s approval, dentists and hygienists can be assured of the technology’s reliability and adherence to regulatory standards.  Adravision’s software as a medical device — or SaMD — utilizes real-time artificial intelligence to assist dentists and hygienists in measuring mesial and distal bone levels in bitewing and periapical radiographs.

 

The resulting data enables dentists and hygienists to diagnose and plan treatments for periodontal disease seamlessly. This is critical since considering its prevalence, periodontal disease affects up to 90% of the population, ranking as the most common oral ailment.

In assessments of clinical performance, Adravision Perio has demonstrated automated measurement capabilities akin to a proficient team of dentists. “During the creation of Adravision Perio, we actively leveraged extensive clinical knowledge, participating in rigorous testing and validation procedures. Specialized clinicians painstakingly annotated tens of thousands of instances depicting bone levels in diverse clinical scenarios, contributing significantly to the successful training of Adravision's algorithms. Adravision's AI-driven solution can help dentists and hygienists to more effectively identify signs of periodontal disease which affects more than 45% of U.S. adults,”  said Dr. Hamed Fesharaki (BDS), the company’s CEO.

 

Left untreated, periodontitis can lead to tooth loss, inability to chew, and has been linked to heart disease and arthritis, among other health ailments. More broadly, the estimated cost to the U.S. economy from untreated periodontal disease is about $154 billion, according to the American Academy of Periodontology.

 

Furthermore, Adravision’s Perio technology simplifies patient understanding of their medical issues, increasing treatment acceptance rates. Fesharaki emphasized Adravision’s goal is “to empower dentists and hygienists, enabling them to serve their patients more effectively and with higher quality”. 

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