FDA clears the CATS®-D Disposable Tonometer Prism.

The FDA has cleared the CATS®-D Disposable Tonometer Prism for sale in the United States, assuring that eye care clinicians have accurate intraocular pressure (IOP) measurement data — a key metric — for the diagnosis and treatment of glaucoma and other serious ocular conditions.

The patented CATS®-D Tonometer Prism is designed to deliver improved IOP measurement accuracy with a sterile, disposable tip replacement for the Goldmann tonometer.

THE EYES HAVE IT!

The FDA clears the CATS®-D Disposable Tonometer Prism.

CATS Tonometer, LLC is thrilled to share great news with you. The FDA has cleared the CATS®-D Disposable Tonometer Prism for sale in the United States, assuring that eye care clinicians have accurate intraocular pressure (IOP) measurement data — a key metric — for the diagnosis and treatment of glaucoma and other serious ocular conditions.

The patented CATS®-D Tonometer Prism is designed to deliver improved IOP measurement accuracy with a sterile, disposable tip replacement for the Goldmann tonometer.

The CATS®-D is available for sale in fall 2021.

The FDA-cleared and patented CATS®-D Tonometer Prism promises to be a welcome advancement and will be available for purchase this fall. Available in both reusable and disposable options, the CATS®-D prism’s ergonomic function, aesthetic appeal and infection mitigation add to its clinical appeal while helping protect patients and staff from infections like COVID-19.

CATS Tonometer, LLC also received international patent protection.

In addition to the United States, which previously granted device and methodology patents, the CATS® Tonometer Prism technology recently received notices of methodology patent grants in Japan, Australia, Canada, and the European Union.

Clinical trials published in peer-reviewed journals and presented at conferences.

CATS Tonometer, LLC continues to publish successful clinical trials, further validating the CATS® technology within Clinical Ophthalmology and Current Eye Research.

CATS Tonometer technology was presented by Key Opinion Leaders this year at the following medical conferences and events:

  • European Society of Cataract and Refractive Surgeons (ESCRS) 38th Congress
  • Association for Research in Vision; Ophthalmology (ARVO)

Expanded claims of improved IOP accuracy.

The National Eye Institute (NEI) $1.1 Million Award, granted in 2019, supports CATS Tonometer LLC’s efforts to expand the current FDA-cleared indications. We are collaborating with the FDA to solidify the path to achieve expanded claims of superiority.

Thank you for following our progress!

“We are so pleased to share our good news with you,” says CATS Tonometer, LLC CEO Sean McCafferty, MD, FACS said. “CATS is positioned for ongoing success thanks to the FDA clearance of the CATS®-D sterile, single-use prism, coupled with the international patent protection, growing enthusiasm among clinical eye care professionals, and the generous support from the NEI, the Arizona Commerce Authority and the Flinn Foundation.”

Twitter
LinkedIn
Posted in AZBio News.