Gradient Denervation Technologies announced today that the FDA accepted it into its Total Product Life Cycle Advisory Program (TAP). TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread access to medical devices. The company expects its acceptance into … [Read more...] about FDA adds Gradient denervation tech to advisory program
Gradient Denervation Technologies
Gradient adds former Edwards exec to board as FDA approves trial expansion
Gradient Denervation Technologies announced today that it appointed medical device entrepreneur and executive Stanton Rowe to its board. Paris-based Gradient also said the FDA approved an expansion of its early feasibility study of its hypertension treatment. The company develops a minimally invasive, ultrasound-based catheter device for … [Read more...] about Gradient adds former Edwards exec to board as FDA approves trial expansion
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary tension with associated heart failure. Paris, France-based Gradient already enrolled the first patient at Duke University … [Read more...] about Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation raises $15M Series A for catheter tech
Gradient Denervation Technologies announced that it closed a $15 million (€14 million) Series A financing round. Paris-based Gradient develops a catheter-based solution for treating pulmonary hypertension. It expects the financing to support the ongoing clinical development and evaluation of the ultrasound-based device. Asabys Partners led … [Read more...] about Gradient Denervation raises $15M Series A for catheter tech
