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FDA Updates Class I Recall Alert For SynCardia's Bridge-To-Transplant System

 
• By Sue Darcey

SynCardia Systems' Freedom Driver System was subject to a class I recall last year, and now US FDA has updated its concerns about a component of the firm's Temporary Total Artificial Heart based on post-approval study data, and is asking that malfunctioning drivers be returned to the manufacturer.

Following up on a voluntary class I recall initiated by SynCardia Systems Inc. in August 2015, US FDA provided updated information about malfunctions and mortalities with the recalled Freedom Driver and the related SynCardia TAH-t Companion 2 Driver seen in post-approval studies. The on Oct. 26 update includes a request that providers return any of these devices with problems to the manufacturer.

The devices are associated with SynCardia's Temporary Total Artificial Heart (TAH-t) system. The difference between the C2 Driver system and...

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More from United States

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• By Natasha Barrow

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

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• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.

‘Dawn Of FDA’s AI Era’ Has Arrived. Makary Announces Early Implentation Of ‘Elsa’ Platform

 
• By Brian Bossetta

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DeepLook AI Imaging Provides A Deeper Look At Dense Breast

 
• By Brian Bossetta

DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.

More from North America

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

SAGA Diagnostics Launches Early Breast Cancer MRD Detection Test In US

 
• By Natasha Barrow

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.

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• By Natasha Barrow

Valued at over $1.9bn, ConcertAI is building on its pre-existing multi-agentic AI SaaS solution CARAai to bring life science customers the new Precision suite of applications: Precision Explorer, Precision Trials, Precision GTM and Precision360.