Over the past 12 months, a number of medtech companies at various stages hauled in significant funding rounds to support their innovations. Technologies that were supported by hundreds of millions of dollars in 2024 included pulsed-field ablation, brain-computer interfaces (BCIs), AI-enabled surgical software and more. In all, the amount of medtech companies receiving more than […]
Impulse Dynamics
Impulse Dynamics expands leadership team
Impulse Dynamics this week announced four new appointments to its executive team. The company appointed Noel Colón as chief operating officer, Peter Donato as chief financial officer, Paul Bae as chief administrative officer and Anthony Hong as chief science and strategy officer. “We are pleased to add these proven leaders to the Impulse Dynamics executive […]
Impulse Dynamics raises $136M for heart failure therapy
Impulse Dynamics announced today that it raised $136 million in financing to accelerate its investment in its heart failure therapy. Perceptive Advisors, Redmile Group, Alger and Hobart Healthcare led the financing round. The company expects it to accelerate investment in global commercialization, technology, product innovation and clinical evidence development. Marlton, New Jersey–based Impulse Dynamics plans […]
CMS agrees to cover ‘breakthrough’ medical devices
Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning. Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date a breakthrough device’s FDA market authorization would begin and continue for 4 years. […]
The 18 most innovative medical devices of 2020
The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical and technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien process, we are honored […]
Impulse Dynamics appoints medical director
Cardiac contractility modulation (CCM) therapy developer Impulse Dynamics announced that it is appointing Dr. Ishu Rao as its medical director. Rao previously spent 17 years in a clinical practice treating heart failure patients, with a focus on interventional therapies, according to a news release. He received his cardiology training at Harbor-UCLA Medical Center in Torrance, […]
Impulse Dynamics completes $80m round
Impulse Dynamics announced today that it completed a Series D financing round with new investors providing more than $80 million to the cardiac contractility modulation (CCM) therapy developer. The company said proceeds from the funding round totaling $80.25 million will be used to facilitate U.S. commercialization of its FDA-approved Optimizer Smart implantable device for CCM […]
FDA approves Optimizer Smart heart failure device from Impulse Dynamics
Updated to include commentary from Impulse Dynamics. The FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation. The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the […]
FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator
The FDA’s Circulatory Systems Device Panel this week voted in favor of Impulse Dynamics’s Optimizer Smart implantable pulse generator, supporting the company’s premarket approval application seeking clearance for use in patients suffering from heart failure, according to a Healio report. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency […]
Impulse Dynamics wins FDA panel date for Optimizer PMA
Impulse Dynamics has set a date with the FDA’s Circulatory System Devices Panel, part of the agency’s Medical Device Advisory Committee, discussing the premarket application for the company’s Optimizer Smart impulse generator device. The Optimizer impulse generator is designed to remodel the myocardium to increase the heart’s efficiency using what the company calls the cardiac contractility […]
HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant
Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis. There were 74 incidences of DRT in 65 of the 1,739 Watchman […]
