Perimetrics, Inc. Receives FDA Clearance for InnerView® Hardware and to Measure Damping Characteristic of the Periodontium and Associated Fixtures
Data collected will help diagnose tooth and dental implant mobility, an indicator of underlying health issues such as periodontal disease
Redmond, Wash., Sept. 12, 2023 – Perimetrics, Inc., an advanced artificial intelligence (AI) dental diagnostics company, today announced the U.S. Food and Drug Association (FDA) granted clearance for its InnerView® device, including the wireless handpiece, charging base station and disposable tip with embedded smart chips. It also received clearance for InnerView to measure the damping characteristic of the periodontium and its associated fixed structures including teeth and implants. It can be used to provide data to quantify tooth and dental implant mobility. This is the first FDA clearance for Perimetrics’ InnerView, which will be available commercially once it is cleared for additional indications, expected in early 2024.
Tooth mobility is the horizontal or vertical tooth movement beyond what is normal when force is applied. It may be an indicator of periodontal disease or another issue such as inflammation. Through a handheld, wireless handpiece, InnerView utilizes light taps on either a tooth or implant. A sensor on the handpiece detects micro movements invisible to other diagnostic tools. A smart chip is housed in a single-use disposable tip to prevent reuse. HIPAA-compliant data will be captured in nearly real time to detect damage. With the use of proprietary software, data from each tooth will be analyzed, providing the clinician with a better understanding of what is going on inside the tooth.
“This FDA clearance for the hardware and indication of the damping characteristic is the first step as we seek to revolutionize the way dentistry diagnoses cracks, failing restorations and mobility,” said Robert Hayman, CEO, chairman of Perimetrics. “Mobility in a tooth or dental implant is a great indicator that there may be damage, including periodontal disease or bone loss. Once InnerView is available in the marketplace, it will be an innovative tool to help clinicians detect tooth damage, which has proven to be difficult.”
Current structural diagnostics used in dentistry are minimally effective, leaving many cracks, failing restorations and mobility issues undetected. X-rays primarily detect decay and certain bone-related issues, but rarely identify damage, a problem that is more prevalent than decay. Once InnerView is available commercially to dentists in early 2024, it will be a first-of-its-kind dental diagnostic system that will utilize artificial intelligence to help detect cracks, failing restorations and mobility in teeth. InnerView works by using Quantitative Percussion Diagnostics™ (QPD), a mechanical test that analyzes the structural integrity of teeth and dental implants and utilizes light taps on either a tooth or implant. A sensor on the handpiece detects micromovements and structural defects invisible to other diagnostic tools. Once InnerView is cleared for additional indications, it is anticipated that it will be available regionally to dentists in Q2 2024, with national distribution by the end of 2024.
“Tooth and implant mobility is a common issue I see in my practice,” said Cherilyn Sheets, DDS, director and co-founder of Perimetrics, who also is in private practice in Newport Beach, California. “This indication will advance how we can diagnose mobility in teeth, helping clinicians improve patient outcomes once InnerView is brought to market.”
About Perimetrics, Inc.
Perimetrics, Inc. is an advanced artificial intelligence (AI) diagnostics company that develops innovative solutions for dentistry. Through our collaborative model, we fuse science, engineering and technology together to develop advanced diagnostics for dentistry, solving the number one issue of undiagnosable cracks and failing restorations. For more information on Perimetrics and InnerView® Technology, visit https://www.perimetrics.ai/.
