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Senior Reporter
Virginia, USA
+5 year(s) experience
Medtech Insight
A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
Topic Coronavirus FDA Diagnostics
Medtech Insight
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation
Medtech Insight
The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.
Topic Coronavirus
Medtech Insight
A rapid-response test from Danaher business unit Cepheid will be the first quick COVID-19 diagnostic to reach the US market, the US FDA announced on 21 March.
Topic Coronavirus Medtech
Medtech Insight
A recent US FDA webinar offered insights on the technical challenges developers face in trying to get COVID-19 diagnostics to US patients.
Topic Coronavirus
Medtech Insight
A proposal from the US FDA would end quarterly publication of PMA and Humanitarian Device Exemption verdicts in the Federal Register. The agency says the practice is inefficient and duplicates online publication.
Medtech Insight
A newly approved contact lens from CooperVision promises to slow the progression of nearsightedness when prescribed to children aged 8 to 12.
Topic FDA
Medtech Insight
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
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
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
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
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
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
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program.
Medtech Insight
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
31 Jul 2020
HBW Insight
29 Jul 2020
Medtech Insight
29 Jul 2020
Medtech Insight
28 Jul 2020
Medtech Insight
27 Jul 2020
Medtech Insight
23 Jul 2020
Medtech Insight
20 Jul 2020
Medtech Insight
16 Jul 2020
Medtech Insight
15 Jul 2020
Medtech Insight
14 Jul 2020
Medtech Insight
09 Jul 2020
Medtech Insight
07 Jul 2020
Medtech Insight
06 Jul 2020
Medtech Insight
02 Jul 2020
Medtech Insight
30 Jun 2020
