FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device
Executive Summary
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.
You may also be interested in...
News We're Watching: Accenture Expects 'More Human' Tech, Cardiac Genetic Tests In Walmart; And More
Medtech Insight's News We're Watching highlights a few noteworthy industry developments you might have missed: Accenture's new Vision Report addresses the future of "more human" tech in health care; Efemoral secures FDA's breakthrough status for its bioresorbable peripheral stent; Impulse Dynamics secures $135m to support its cardiac contractility modulation; PrecisionLife and Metrodora announced a partnership to address chronic diseases including long COVID; Cardio Diagnostics launches its cardiac epigenetic/genetic tests in a Walmart near Chicago.
FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device
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.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.