Cook Medical recalled its Transseptal Needle and Transseptal Needle with Catheter on 18 October because there could be rust on the outside or inside of the product.
Complaints to Cook Medical LLC about rust on medical needles they manufacture prompted the company to initiate a recall of the products on 18 October.
The firm recalled its Transseptal Needle and Transseptal Needle with Catheter because the presence of rust “could result in increased procedural time and inflammatory reactions, including systemic reactions which may...
The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.
A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
