USA – This Week at FDA: User fee update, Califf nomination…

Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming...

USA – US FDA lays out post-COVID EUA transition plans for medical devices

The US Food and Drug Administration has published transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public...

USA – Draft Guidance : Transition Plan for Medical Devices Issued Emergency Use Authorizations...

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19)...

USA – FDA seeks comment on device shortage reporting guidance

The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA issues draft guidance on assessing physiologic closed-loop control devices

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with...
Data from patient registries to replace clinical trials in previously untreated haemophilia patients

USA – New blood test can identify presence of cancer

Cancer researchers at the University of Oxford have developed a new type of blood test, which can be used to detect a range of...

USA – Computational modeling and simulation: FDA outlines framework for assessing credibility

With the use of computational modeling and simulation (CM&S) in medical device submissions on the rise, the US Food and Drug Administration (FDA) last...

USA – CES 2022: focus sur quatre entreprises en santé lauréates des « Innovation Awards »

PARIS (TICpharma) - Alors que le Consumer Electronics Show (CES) s'est ouvert le 5 janvier, retour sur les "Innovation Awards" décrochés par les sociétés...

USA – Covid-19 : les tests antigéniques seraient moins sensibles au variant Omicron

Les tests antigéniques de dépistage du Covid-19, qui ont l'avantage de délivrer un résultat en quelques minutes seulement, sont moins sensibles au variant Omicron qu'aux variants précédents,...

USA – Un algorithme associé aux montres connectées Fitbit apparaît fiable pour détecter la...

DALLAS (TICpharma) - Un nouvel algorithme pour montre connectée permet d'identifier des fibrillations atriales non diagnostiquées dans la population générale, avec une bonne fiabilité,...

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