Medtech Insight: 世界の医療機器・医療技術の最新情報
US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.
Topic Coronavirus fda
Medtech Insight: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
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: 世界の医療機器・医療技術の最新情報
The US agency is looking for ways to open its upcoming Voluntary Medical Device Manufacturing and Product Quality Program.
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