ABCD Study Results: Will Noninvasive T-Wave Test Boost ICD Referrals?

Data presented Nov. 15 helps validate microvolt t-wave alternans (MTWA) analysis for identifying certain patients at high risk for sudden cardiac death, but questions remain about the test's potential impact on physician practice

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SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 

SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.

Siemens Healthineers Widens FY25 EPS Range By €0.15 To Absorb Up To €300M In Tariff Costs

 
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The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.

FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.