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St. Jude launching Trilogy DR+ high-end pacemaker; SR+ pending at FDA.
ST. JUDE MEDICAL TRILOGY DR+ PACEMAKER U.S. LAUNCH provides the firm with a new entry in the largest selling class of pacemakers in the U.S. St. Jude's cardiac rhythm management business, Pacesetter, received the go-ahead from FDA Sept. 30 to begin selling its dual chamber, rate-responsive pacemaker. The device was cleared by FDA nearly six months after the firm submitted its premarket approval application supplement.
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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.
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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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Waters Corp. will acquire Becton Dickinson’s Biosciences and Diagnostics business for $17.5bn, doubling its TAM to $40B. Analysts praise the flow cytometry addition but see weaker growth in diagnostics.
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MedTech Europe wants the EU to continue its commitment to reach a negotiated tariff solution with the US and measured restraint amid escalating trade tensions.
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The European Commission is focusing on how tiny particles behave to help create an EU industrial “powerhouse.”