CATS Tonometer adds AI glaucoma risk software to FDA-cleared prism

CATS Tonometer is building an AI-enabled glaucoma subscription service that moves beyond pressure measurement to help clinicians assess risk and model treatment scenarios. The planned platform builds on FDA-cleared hardware and published research linking its modified-prism readings to glaucoma damage.

Why it matters: - Glaucoma care has long relied on intraocular pressure as the main metric, but pressure alone does not fully capture a patient’s risk of optic nerve damage. - CATS Tonometer’s planned software aims to combine pressure readings, retinal nerve fiber layer trends and risk modeling in one clinical workflow. - The shift could move the company from a device business into recurring clinical software tied to longitudinal glaucoma management.

What happened: - CATS Tonometer, LLC said it is developing an AI-enabled glaucoma software subscription service that extends its FDA-cleared tonometer prism into risk assessment and treatment-scenario modeling. - The company said the planned service is built for practices already using the FDA-cleared CATS Tonometer Prism (K173904). - Sean McCafferty, founder and CEO of CATS Tonometer, said: “Glaucoma care has measured pressure for nearly 70 years. We are making it predict damage.”

The details: - The planned subscription service is designed to combine RNFL and pressure reference charts, multifactor assessments of glaucoma onset and progression risk, and treatment-scenario comparisons using published intraocular pressure equations. - CATS says the goal is to place each pressure measurement within a patient-specific view of glaucoma risk and management. - The company says the platform would let clinicians compare pressure and RNFL trends, review multiple contributors to glaucoma risk, and model pressure responses to possible interventions. - Prototype charting and risk-assessment tools are in development for in-house use. - CATS says each subscribing practice would contribute governed patient-outcome data that, together with AI-assisted evidence review and new research, would refine versioned models over time. - The company says clinician-facing models are planned as dated, version-controlled releases with transparent factor contributions. - CATS has filed patent applications covering its glaucoma progression and diagnostic software. - The software is in development, and the prism’s FDA clearance does not extend to the planned software.

Between the lines: - The company is pairing hardware that measures eye pressure with software that interprets what those readings may mean for future disease progression. - The strategy also creates a data flywheel: more practice-level data could improve the model, which could make the service more useful and sticky over time. - CATS is positioning the platform as a transparent alternative to black-box algorithms by emphasizing dated, version-controlled models and stated factor contributions. - The move also broadens the company’s commercial footprint into ophthalmic devices, diagnostics, therapeutics and digital health partnerships.

What happened: - A 2025 study in BMC Ophthalmology found that at intraocular pressure of 22 mmHg or higher, CATS modified-prism readings were associated with 2.57 times greater probability of significant retinal nerve fiber layer loss than standard Goldmann prism readings, with p<0.0001. - The company said its scientific foundation includes peer-reviewed engineering studies, direct comparisons with intracameral pressure and multicenter randomized clinical trials. - McCafferty and John Berdahl published intraocular pressure equations in Clinical Ophthalmology in 2025 that model steady-state pressure and pressure changes over time using aqueous-fluid flow relationships. - CATS said additional peer-reviewed research on aqueous inflow and outflow facility modeling has been submitted for publication.

What's next: - CATS said the subscription service is in development and prototype tools are being built for internal use. - The company said it welcomes discussions with investors, clinical collaborators and strategic industry partners. - CATS said its focus is connecting pressure measurement, predictive modeling and longitudinal glaucoma care. - Media and strategic inquiries go to Early Signal Diagnostics Corp., the parent company of CATS Tonometer.