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FDA Approves Impulse Dynamics’ Optimizer Smart For Heart Failure As Breakthrough Device

Executive Summary

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.

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Device/Diagnostics Quarterly Dealmaking Statistics, Q4 2019

Device financing during 2019’s final quarter totaled $1.6bn, a substantial decrease from Q3’s $4.05bn. Merger and acquisition activity, almost doubled from the previous quarter reaching $6.1bn; Stryker’s 4.7bn takeover of Wright Medical was the only billion-dollar transaction. Financings by diagnostics/research players totaled $1.3bn (the lowest quarter of the year) and eight companies were acquired, five of which together were valued at $981m.

Global Device Approvals Snapshot For March 18 - March 25, 2019

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.

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

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.

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