Pulmonary valved conduit receives FDA Humanitarian Device Exemption approval, firm announces Nov. 24. The bioprosthetic, composed of a bovine jugular vein containing an integral valve that can be used to reconstruct a blood pathway from the right ventricle to the lungs, corrects congenital defects of the right side of the heart in patients under 18. Contegra can be used instead of a human valve, supplies of which are limited, Medtronic notes. The company has been distributing the device outside the U.S. since 1998 and acquired the product from VenPro in 2001...
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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.
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.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
Surgify Medical’s selective drill tip, Surgify Halo, is “an obvious choice for surgeons,” said Boris Hofmann, head of ZEISS Ventures and lead investor in the company’s series A funding round.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
