Impulse Dynamics Archives - Medical Design Sourcing

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 to use funds to support, among other things, its INTEGRA-D and AIM HIGHer trials. The company develops the Optimizer Smart Mini system to deliver cardiac contractility modulation (CCM) therapy to the heart. It significantly improves heart contraction to allow more oxygen-rich blood to push out through the body.

INTEGRA-D evaluates the combination of the company’s proprietary CCM therapy with implantable cardioverter defibrillator (ICD) therapy. All this comes through a single device — the Impulse Dynamics Optimizer Integra CCM-D system.

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The best medtech innovations of 2023

Recognize this medtech innovation? It was one of the nominees for the Galien Foundation’s 2023 Prix Galien USA Awards. [Image courtesy of Boston Scientific]

The Galien Foundation’s 2023 Prix Galien USA Awards recognized a first-of-its-kind cancer diagnostic and other medtech innovations.

Announced last week, the Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

“The outstanding quality of the submissions is a testament to the promising future of the life sciences industries,” said former Johnson & Johnson CEO and Chair Alex Gorsky — one of the awards jurors — in a news release announcing the nominees.

Last year’s winners included Cala Health, Abbott, Edwards Lifesciences and Roche. (See all of 2022’s nominees here, including many that were nominated again in 2023.)

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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 of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…

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 to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

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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 to announce this year’s Prix Galien USA nominees, which represent the determination and passion for change that serves as the driving force of life-changing innovation,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Committees, in a news release. “The awards committee applauds the nominees for their commitment to ensure a healthier future for generations to come.”

Nominees need to be FDA-approved for the market within the last five years, and show major potential to affect healthcare. The winners will be announced in October th…