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The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing...
USA – FDA issues draft guidance on assessing physiologic closed-loop control devices
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with...
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,...
USA – Discussion Paper: 3D Printing Medical Devices at the Point of Care
The Center for Devices and Radiological Health (CDRH) is committed to assuring that patients and providers have timely and continued access to safe, effective,...
USA – Pharma, device groups oppose FDA’s planned drug to device transition
Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging...
USA – Groups request clarifications to safety reporting draft guidance
Two industry trade associations and a pharmaceutical company are asking for some adjustments and clarification on the US Food and Drug Administration’s (FDA’s) draft...
