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Alere Hit With Another Federal Subpoena, Casting More Doubt On Abbott Deal

 
• By Reed Miller

The company says the matters under investigation are immaterial, but the stock market disagrees, taking about a billion dollars from embattled diagnostics company in under a half-hour.

Alere Inc. announced late on July 27 that it received a subpoena from the US Justice Department for records related to Federal health-care program billings as far back as 2010.

The announcement is the latest in a string of difficulties that may jeopardize Abbott Laboratories Inc.’s planned $5.8bn acquisition of the diagnostics company. (Also see "Look Over Your...

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Cardiosense Advances Noninvasive Heart Monitoring With Final Validation Study

 
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Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.

ConcertAI Launches Generative AI-Powered Precision Suite

 
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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
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Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

More from Medtech Insight

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 
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Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Execs On The Move: 12-23 May 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.