Agency’s final national coverage determination for beta amyloid positron emission tomography to diagnose dementia confirms that Medicare will cover the procedure only in clinical trials. On the positive side, it may offer a bit more flexibility in trial design.
CMS’ final Medicare national coverage determination on beta amyloid positron emission tomography for brain imaging may offer a little more flexibility in the types of outcomes studied in clinical trials, the only setting where Medicare will pay for the test. (See [A#14131002001].)
Nevertheless, the final decision was a disappointment to medical imaging manufacturers and drug makers.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
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.
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.
