Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 22 Jun 2021
The exemptions allow for face masks, diagnostics and oxygen tanks, among others, to be shipped to Iran, Syria and Venezuela without specific permission.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 15 Jun 2021
The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 04 May 2021
The settlement resolves allegations the neurosurgeon collected kickbacks both for using Medtronic devices and for buying devices through his own distributorships.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 17 Mar 2021
The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 27 Nov 2020
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
By elizabeth-orr 27 Nov 2020
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
By elizabeth-orr 27 Nov 2020
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
By elizabeth-orr 27 Nov 2020
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
Pink Sheet: 世界の薬事規制と承認審査に関するニュース
By elizabeth-orr 09 Oct 2020
Textualist judges appointed by President Trump during his term may block a potential President Biden’s attempts to shift the government’s legal policies.
Medtech Insight: 世界の医療機器・医療技術の最新情報
By elizabeth-orr 05 Jun 2020
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
By elizabeth-orr 12 Mar 2020
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
By elizabeth-orr 18 Dec 2019
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
By elizabeth-orr 20 Nov 2019
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
By elizabeth-orr 02 Jul 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: 世界の医療機器・医療技術の最新情報
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
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