FDA Approves RESPeRATE Device for Marketing

InterCure Inc. (New York) has received FDA marketing clearance for its RESPeRATE stress-reduction device, which leads users through interactively guided and monitored breathing exercises.

The product is indicated as an adjunctive treatment for high blood pressure under the direction of a physician, together with other pharmacological and/or non-pharmacological interventions as prescribed. It is the first device to receive FDA marketing clearance as an adjunctive treatment for high blood pressure reduction.

RESPeRATE is the cornerstone of InterCure's RESPeRATE for Lower Blood Pressure program. The program integrates the device with a data-recording blood pressure monitor and a website that automatically captures a patient's treatment and blood pressure data to allow patients to track progress. In addition, personal case managers are available to answer questions, provide feedback, and monitor RESPeRATE compliance. The program also generates reports that can be used by the patient's physician to manage the condition.

InterCure is currently conducting clinical trials in the United States, Europe, and Israel to explore additional therapeutic applications of RESPeRATE technology in other chronic conditions including congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), and asthma.

Edited by Jim Pomager