Perimetrics receives FDA clearance for InnerView hardware and to measure damping characteristic of the periodontium

Perimetrics InnerView
Perimetrics anticipates that the InnerView will be available regionally to dentists in the US around Q2 2024, pending additional FDA clearances (Image: RKS Design)

Artificial intelligence (AI) dental diagnostics company Perimetrics, announced that the US 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.

InnerView is a dental diagnostic system which uses AI to detect cracks, including failing restorations in teeth, and potentially problematic mobility issues, non-invasively with zero pain and radiation according to the company. With the use of software, data from each tooth will be analysed, aimed at providing clinicians with a better understanding of what is going on inside the tooth.

Through a handheld wireless handpiece, the InnerView device works by using quantitative percussion diagnostics (QPD), a mechanical test that analyses the structural integrity of teeth and dental implants and utilises light taps on either a tooth or implant. A sensor on the handpiece detects micro-movements reportedly invisible to other diagnostic tools. A smart chip is housed in a single-use disposable tip to prevent reuse and data compliant with the Health Insurance Portability and Accountability Act (HIPAA) is captured in nearly real time to detect damage.

Perimetrics InnerView
A screenshot from the InnerView System patient diagnostic screen from the company’s investor presentation (Image: Perimetrics)

Furthermore, Perimetrics also received clearance for InnerView to measure the damping characteristic of the periodontium and its associated fixed structures including teeth and implants, which can reportedly be used to provide data to quantify tooth and dental implant mobility. Tooth mobility is the horizontal or vertical tooth movement beyond what is normal when force is applied, which may be an indicator of periodontal disease or another issue such as inflammation.

“This FDA clearance for the hardware and indication of the damping characteristic is the first step as we seek to revolutionise the way dentistry diagnoses cracks, failing restorations and mobility,” said CEO and chairman of Perimetrics, Robert Hayman. “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.”

According to the company, current structural diagnostics used in dentistry are minimally effective, leaving many cracks, failing restorations and mobility issues undetected. It adds that X-rays primarily detect decay and certain bone-related issues, but rarely identify damage, a problem that is more prevalent than decay. With this first FDA clearance for Perimetrics’ InnerView, the company anticipates that it will be available regionally to dentists in Q2 2024 with national distribution by the end of 2024, once InnerView is cleared for additional indications from the FDA.

“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.”

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