FDA will immediately begin recognizing the third edition of the International Electrotechnical Commission's (IEC) family of standards for medical electrical equipment safety and performance. The third edition of IEC 60601 represents a major overhaul of the existing standard, namely by requiring medical electrical equipment manufacturers to have formal risk-management processes in place. The third edition was published in 2005, but FDA reviewers needed time to adjust to the new risk-management piece, FDA's standards management director Carol Herman explained at a March 9 session of the AAMI/FDA International Conference on Medical Device Standards and Regulation in Reston, Va. Firms will have three years to switch over to the new standard. A Federal Register notice on the topic is expected soon, Herman said
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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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
The medtech M&A landscape is experiencing a resurgence fueled by significant capital from private equity and venture firms, says Alex Wakefield, CRO of AcuityMD. Building strong relationships with physicians remains crucial in medtech, and defining an exit strategy early is imperative.
