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Roche Wins FDA Breakthrough Device Designation For Alzheimer’s Test

 
• By Marion Webb

Roche announced on 11 April it received FDA breakthrough device designation for a blood test used for early detection of Alzheimer’s disease.

Alzheimer's
• Source: Shutterstock

Roche Corp.’s Elecsys pTau217 plasma biomarker test, which has been granted US Food and Drug Administration breakthrough device designation and was developed in partnership with Eli Lilly and Company, helps identify the presence or absence of amyloid pathology of Alzheimer’s disease.

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More from Approvals

Precision Neuroscience’s FDA Clearance For Core Component Of Brain Implant Expected to Accelerate R&D

 
• By Marion Webb

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• By Natasha Barrow

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Dexcom Wins FDA Nod For 15-Day G7 CGM, Closing Gap With Abbott’s 14-Day FreeStyle Libre

 
• By Marion Webb

Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

CardioVia Secures FDA Clearance Epicardial Access Needle ViaOne

 
• By Natasha Barrow

A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.

More from Policy & Regulation

Makary Proposes Combined Adverse Event Reporting Systems In Megyn Kelly Interview

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

FDA Issues A Pair Of Early Alerts For Intravascular Catheters

 
• By Brian Bossetta

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Upcoming CMS Meetings Address Tremor-Control Devices, Lab Test Reimbursement

 
• By Elizabeth Orr

The US Medicare agency will hold three public meetings in June and July addressing tremor treatment devices and clinical diagnostic lab tests. The first meeting on June 25 will focus on endpoints for Parkinson’s device trials, while subsequent meetings will address payment rates and codes for laboratory tests.