Traditionally, the market for medical device initial public offerings of stock trails the opening of the biopharma window by a year or two. But the string of biopharma IPOs over the past two years has looked like a never- ending train. When would medical device start-ups jump on? The time may be now. Venture capitalists privately are reporting interest from investment bankers over the past few months. The strength of the markets coupled with the solid revenue of many venture-backed device companies may make public exits possible in the new year. But at least some of the credit will need to go to those pioneers willing to test the water.
Spine Tingling After LDR Holdings’ IPO
Spine company LDR Holdings Corp. helped signal a turnaround in the spine industry with a successful IPO in October, netting $80 million. Privately, venture capitalists are reporting greater interest in their companies from Wall Street bankers, but should LDR’s success be seen as a strong signal for devices?
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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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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?
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Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
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A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.