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FDA Grants 510(k) Clearance To Roche’s Tina-quant Molarity Assay

Summary by Plato. Vertical Search. Ai. | PlatoAiStream. Data Intelligence. Vertical Search. Ai.

The test is conducted through a routine blood draw and measures the concentration of Lp(a) particles in the bloodstream. Credit: Nuttapong punna / Shutterstock. The US Food and Drug Administration (FDA) has granted 510(k) clearance to Roche’s Tina-quant Lipoprotein (a) Gen.2 Molarity assay. This is said to mark the first assay of its kind in the US to measure lipoprotein (a), also known as Lp(a), in nanomoles per litre (nmol/L). As per the Natio…

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medicaleconomics.com

Roche receives FDA Clearance for blood test that assesses cardiovascular risk

Test is the first measuring lipoprotein (a) in nmol/L and will help assess cardiovascular disease risk in adults

25 days ago

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Plato. Vertical Search. Ai. | PlatoAiStream. Data Intelligence. Vertical Search. Ai.

FDA Grants 510(k) Clearance To Roche’s Tina-quant Molarity Assay

25 days ago

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Medical Device Network

HeartBeam submits 510(k) application to FDA for ECG software

HeartBeam has submitted a 510(k) application to the FDA for its 12-lead ECG synthesis software to assess cardiac rhythms and arrhythmias.The post HeartBeam submits 510(k) application to FDA for ECG software appeared first on Medical Device Network.

25 days ago

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cardiovascularbusiness.com

FDA clears first blood test of its kind for Lp(a)

The new blood test from Roche Diagnostics measures Lp(a) in terms of nanomoles per liter (nmol/L) as opposed to milligrams per deciliter (mg/dL).

26 days ago

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Clinical Lab Products

Roche Lp(a) Test Gets FDA Clearance for Cardiovascular Risk Assessment

Summary: Roche’s Tina-quant Lp(a) Gen.2 Molarity assay received FDA 510(k) clearance, supporting more precise cardiovascular risk assessment. Takeaways: First FDA-Cleared Lp(a) Test in nmol/L – Roche’s assay aligns with scientific consensus, providing more accurate Lp(a) measurements by counting particles rather than measuring mass. Improved Cardiovascular Risk Assessment – Elevated Lp(a) is a genetic risk factor for heart disease, and the Nati…

26 days ago

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hcplive.com

FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

Awarded to Roche, the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay will be the first 510(k) cleared test measuring Lp(a) in nanomoles per liter (nmol/L).

26 days ago

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