Impulse Dynamics N.V.
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Latest From Impulse Dynamics N.V.
The US Medicare agency is allowing more device procedures to be conducted at outpatient hospitals and ambulatory surgical centers (ASC), while approving several new devices for passthrough payments for three years under its Outpatient Prospective Payment System and ASC payment system final rule for 2020, released on 1 November.
The Optimizer Smart implantable pulse generator delivers Cardiac Contractility Modulation therapy to improve the quality of life and functional status of patients with advanced heart failure who are not indicated for cardiac resynchronization therapy. The agency granted Optimizer Smart as a Breakthrough Device because of its potential to improve outcomes for heart failure patients without other options.
A snapshot of global medical device approvals captured during the past week in Medtech Insight's Approvals Tracker. This week FDA approved Impulse Dynamics’ Optimizer Smart impulse generator for cardiac contractility modulation therapy, CardioFocus’ HeartLight Endoscopic Ablation system earned a CE Mark, and Health Canada approved a new version of DarioHealth’s smart-phone compatible continuous glucose monitor.
A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.
- Implantable Devices
- Other Names / Subsidiaries
- Hobart Group