CardioRenal receives FDA breakthrough designation for Tenor at-home blood potassium measuring device
31 May 2023
Priority ReviewBreakthrough Therapy
CardioRenal today announced it received FDA breakthrough device designation for its Tenor at-home blood potassium measuring device.
Tenor is a connected medical device that combines multiple technologies to assist patients with chronic illnesses, including chronic kidney disease, in measuring their blood potassium levels from the comfort of their homes.
Patients can collect blood for testing at home using Tasso’s Tasso+ blood collection device and doctors can then remotely access the measured data to enable more effective control and normalize patient potassium levels.
“This designation is a tremendous recognition by the FDA of our R&D excellence. It will boost our efforts in bringing the Tenor device to the millions of patients who need it,” CEO Maurice Bérenger said in a news release. “We look forward to working closely with the FDA to start our clinical trials later this year.”
Globally, there are more than 843 million people living with chronic kidney disease. These patients frequently have fluctuating blood potassium levels, according to CardioRenal. As a result, they are exposed to possible cardiac complications, which account for up to 30% of deaths in patients with chronic kidney disease.
The FDA breakthrough devices program will provide CardioRenal with priority review and interactive communication from its experts and senior managers to assist the company on its path to commercialization in the U.S.
“People are increasingly calling for at-home health solutions, and the partnership with CardioRenal is an exciting opportunity to again demonstrate the benefits to patient care,” Tasso CEO and Cofounder Ben Casavant said. “We look forward to demonstrating that our blood collection device can be used in combination with the TENOR system to obtain a blood sample in a way that is convenient, addresses patient needs and meets FDA standards for potassium analysis. This fits perfectly in our mission to combine clinical excellence and patient-centric solutions.”
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