Unique Missions Of FDA, CMS Underscored In Presentations To HHS Panel

Ongoing attempts to coordinate FDA and CMS reviews will preserve approval, coverage, coding and payment as distinct processes, agency representatives concurred at the HHS Secretary's Advisory Committee on Regulatory Reform regional hearing June 10

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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

 
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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.

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

 

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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Device Sterilization Plants Get Extra 2 Years To Comply On EtO Phase-Out

 
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The exemption, which President Donald Trump announced on July 17, is intended to cut the risk of critical device shortages. Stakeholders say the technology needed to cut emissions to required levels is not yet widely available.

Numerous Injuries Prompt Class I Recall Of Dexcom CGM Receivers

 

Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.

J&J Bets On Robotics, Cardiovascular To Grow Medtech As Tariff Hit Eases, US Manufacturing Grows

 
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Worldwide medtech sales totaled $8.5bn in Q2, up 6.1%. Sales grew 8% in the US and 4.1% outside the US. Cardiovascular, surgery and vision were the primary growth drivers. Acquisitions and divestitures had net positive impact of 200 basis points, largely due to the acquisition of Shockwave Medical.