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Architectural pillars

Regulatory front for Feb. 25, 2020

Feb. 25, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: FDA, COVID-19, Eastgate, India’s Central Drug Standard Control Organization, India’s Directorate of Revenue Intelligence, SEC.


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French flags on building

Med-tech companies in France suffering from regulatory inertia in their home market

Feb. 25, 2020
By Bernard Banga
PARIS – The Syndicat National de l'Industrie des Technologies Médicales (SNITEM), the French national association of medical technology manufacturers, has just released a study looking at the development of this industrial sector in that country. This snapshot, produced every two years by the firm D&Consultants SAS on behalf of Courbevoie, France-based SNITEM and the bank Bpifrance SA, is based on a dual quantitative and qualitative approach.
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FDA aims to navigate treacherous AI regulatory waters

Feb. 25, 2020
By Mark McCarty
Developers of artificial intelligence (AI) algorithms have their own nightmares to deal with, but the FDA is charged with employing a regulatory touch that steers clear of rocky shoals on one side and inescapable whirlpools on the other. The FDA’s Bakul Patel said during a Feb. 25 workshop that the FDA would quickly be swamped if the agency took a traditional regulatory approach to managing the super-iterative digital health space, but that the agency will keep a keen eye on the potential impact on patients as AI begins to move into clinical practice.
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2-25-Fresenius-Novalung.png

FDA clears Novalung, the first ECMO system for long-term use

Feb. 25, 2020
By Liz Hollis
The U.S. FDA has given its nod to Novalung, a heart and lung support system from Fresenius Medical Care North America (FMCNA) for the treatment of acute respiratory or cardiopulmonary failure. The Waltham, Mass.-based company noted that Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use.
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Regulatory front for Feb. 25, 2020

Feb. 25, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Tytek Medical.
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Regulatory front for Feb. 25, 2020

Feb. 25, 2020

The latest global regulatory news, changes and updates affecting biopharma, including: Actavis, Horizon, Yibin Lihao.


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Regulatory front for Feb. 24, 2020

Feb. 24, 2020
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Cybersecurity data lock

Cybersecurity requirements, liabilities expanding for device makers

Feb. 24, 2020
By Mark McCarty
U.S.-based device makers have been grappling with FDA cybersecurity requirements for some time, but now the European Union (EU) is working on cybersecurity regulations as well. Throw in privacy requirements by the state of California and the EU’s General Data Protection Regulation (GDPR), and device makers are facing an increasingly complicated world of enforcement and litigation.
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2-24-Cardiovalve.png
CRT20

Cardiovalve wins FDA breakthrough nod for tricuspid valve replacement technique

Feb. 24, 2020
By Meg Bryant
NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
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De novo key on keyboard

FDA gives nod to Asuragen’s Amplidex Fragile X Dx and Carrier Screen Kit

Feb. 24, 2020
By Liz Hollis
Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.
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