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Research Briefs: Studies From Exact Sciences, EndoChoice; Neuroimaging Overuse

In the lead up to an FDA panel, positive data is published for Exact Science’s Cologuard multi-target stool DNA-based screening test. EndoChoice’s Fuse endoscope sees more colon cancer than traditional endoscopes. Overuse of neuroimaging for headaches documented. Long-term study finds high-frequency oscillatory ventilation is better for premature babies than standard ventilation. Drug-coated balloon trial.

In the lead up to a March 27 FDA advisory panel meeting for Exact Sciences Corp.’s Cologuard multi-target stool DNA-based screening test, pivotal data published in the New England Journal of Medicine showed the diagnostic was more sensitive, but less specific, for the detection of colorectal cancer than fecal immunochemical test (FIT). The results from Exact’s 10,000-patient DeeP-C

trial were published online in NEJM on March 19.

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

 
• By Ryan Nelson

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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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• By Marion Webb

AI heart imaging company HeartFlow filed for a $100m IPO after scrapping its 2022 SPAC plans. It remains unprofitable but is betting on FDA clearances, Medicare coverage and a demand for AI-powered diagnostics to win over investors.

FDA Document Request Denied As Case Against SurModics Merger Intensifies

 
• By Elizabeth Orr

A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.

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.