FDA grants breakthrough device designation to new heart failure solution from Berlin Heals

Berlin Heals, an international healthcare technology company focused on heart failure treatments, announced March 11 that its Cardiac Microcurrent Therapy System has received the FDA’s breakthrough device designation.

The implantable solution was designed to target heart failure by delivering a “constant, but minimal” DC current to the heart through two electrodes. Preclinical trials also found that the system also had a “strong anti-inflammatory effect” and improved cardiac function, the company said.

While Berlin Heals has already kicked off a study in Europe to test the solution’s effectiveness, an early feasibility study is also expected to be launched in the United States.

“Our completely novel therapeutic approach has the potential to almost cure heart failure rather than just delaying the progression of the disease,” Berlin Heals CEO Marko Bagaric said in a prepared statement. “The FDA Breakthrough Designation is a tremendous turning point in the approval process for the U.S., enabling us to make our device available to patients with life-threatening heart disease much faster.”