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 w…