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FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR

 
• By Reed Miller

An FDA advisory panel will discuss Abbott’s PMA for the TriClip G4 transcatheter tricuspid valve repair device on 13 February. The group’s discussion will likely focus on the lack of a clear mortality or hospitalization benefit in the TRILUMINATE pivotal trial.

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[Editor's Note: At its 14 February meeting, FDA's circulatory system devices panel voted nearly unanimously in favor of Abbott's TriClip G4, including a 13-1 vote in favor of concluding that the benefits of the technology outweigh its risks. Medtech Insight will have more on TriClip G4 later this week.]

Analysts expect the US Food and Drug Administration to approve Abbott ’s TriClip G4 transcatheter tricuspid valve repair (TTVR)...

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Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

Injuries And Deaths Linked To Baxter Infusion Pump

 
• By Brian Bossetta

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

HeartFlow Takes Another Crack At Public Markets With $100M IPO Filing

 
• By Marion Webb

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Abbott Lowers Outlook But Headwinds Are Temporary

 
• By Natasha Barrow

Despite headwinds, executives remain optimistic about growth in Abbott’s medical devices and diabetes divisions and plan several product rollouts, including the Volt PFA catheter for electrophysiology and the dual glucose-ketone sensor CGM.

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CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

NIH-Backed Scanner Opens New Frontier For Understanding The Human Brain

 
• By Brian Bossetta

A new MRI scanner developed by a team of scientists working with the National Institutes of Health marks a milestone in understanding the complexities of the human brain. Andrea Beckel-Mitchener with the NIH Brain Initiative discusses the significance of this potentially game-changing device.