The Microbiology Devices Panel provided unanimous support Roche’s submission to upgrade labeling for it cobas HPV test as a first-line, primary screen for cervical cancer.
FDA’s Microbiology Devices Panel unanimously supported Roche’s cobas HPV test to be marketed as a first-line cervical cancer screening test during a March 12 meeting.
The panel voted 13-0 on separate votes that the upgraded indication for the assay was safe, effective and the benefits outweighed the risks.
TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 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.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
