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Alere recalls 800,000 Triage tests on quality control issues

 
• By Madeleine Armstrong

Alere has recalled 803,000 of its Triage tests after problems with quality control testing and performance of the diagnostics. The recall affects a total of 104 lots comprising 287,000 Alere Triage BNP (B-type natriuretic peptide) tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests, according to a company filing with the US Securities and Exchange Commission (SEC).

Alere has recalled 803,000 of its Triage tests after problems with quality control testing and performance of the diagnostics. The recall affects a total of 104 lots comprising 287,000 Alere Triage BNP (B-type natriuretic peptide) tests, 46,000 Alere Triage D-dimer tests and 470,000 Alere Triage cardiology panel tests, according to a company filing with the US Securities and Exchange Commission (SEC).

It looks like the company will also have to recall its Alere Triage TOX Drug Screen test: it said it...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Ryan Nelson

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Ryan Nelson

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By Marion Webb

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 
• By Natasha Barrow

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

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FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

ADA 2025: Tandem Becomes Abbott’s Fourth Partner In Push To Advance Dual Sensor CGM Strategy

 
• By Marion Webb

Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.