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Senior Reporter
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Medtech Insight
By Elizabeth Orr 07 Mar 2019
Physicians and researchers in an all-day session at the Cardiovascular Research Technologies conference in Washington, DC, on March 5 largely backed the recent finding that paclitaxel-coated balloons and stents may be tied to a higher patient mortality rate. But the specific mechanism underlying the deaths remains unknown.
Topic Medtech
Medtech Insight
By Elizabeth Orr 07 Mar 2019
4C Medical plans to conduct both an early feasibility study and the pivotal trial for its mitral regurgitation treatment device simultaneously in Japan, the US and Canada. The company says the study is the first early feasibility study in Japan for an implantable device.
Topic Medtech
Medtech Insight
By Elizabeth Orr 07 Feb 2019
The US Department of Homeland Security National Cybersecurity and Communications Integration Center is warning of potential cybersecurity vulnerabilities in Stryker hospital beds and BD diagnostics equipment.
Medtech Insight
By Elizabeth Orr 23 Jan 2019
Despite pushback from industry, US FDA has moved forward with plans to establish a new alternative 510(k) pathway by finalizing a guidance document that describes the so-called “Safety and Performance Based Pathway” that emphasizes use of consensus standards instead of direct predicate comparisons.
Topic FDA
Medtech Insight
By Elizabeth Orr 05 Dec 2018
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.
Topic FDA
Medtech Insight
By Elizabeth Orr 18 Oct 2018
Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.
Topic FDA
Medtech Insight
By Elizabeth Orr 16 Oct 2017
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program.
Medtech Insight
By Elizabeth Orr 24 Mar 2017
The 37 groups and individuals who submitted comments on FDA’s two draft guidances on next-generation sequencing issued in July expressed appreciation for the thinking behind the guidances, but found bones to pick with some details.
Medtech Insight
22 Apr 2019
Medtech Insight
18 Apr 2019
Medtech Insight
17 Apr 2019
Medtech Insight
15 Apr 2019
Medtech Insight
12 Apr 2019
Medtech Insight
11 Apr 2019
Medtech Insight
10 Apr 2019
Medtech Insight
09 Apr 2019
Medtech Insight
04 Apr 2019
Medtech Insight
03 Apr 2019
Medtech Insight
01 Apr 2019
Medtech Insight
29 Mar 2019
Medtech Insight
28 Mar 2019
Medtech Insight
25 Mar 2019
Medtech Insight
22 Mar 2019
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