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. […]
Impulse Dynamics
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 […]
5 medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
Impulse Dynamics raises $45m
Impulse Dynamics said today it closed a $45 million equity financing round to support its cardiac contractility modulation technology designed to treat chronic heart failure. The round was led by Goldstone Investment and was joined by several other international investment firms, the Stuttgart, Germany-based company said. “We believe that CCM addresses a significant unmet need […]
Impulse Dynamics raises $30m for Optimizer IVs implantable heart failure device
Impulse Dynamics said last week that it raised $30 million for its Optimizer IVs implantable heart failure device, led by the Hong Kong investment fund of real estate developer Peter Lee Ka Kit. Stuttgart, Germany-based Impulse said it plans to use the proceeds to expand its commercial footprint for the device, which 1st won CE Mark approval in the […]
