As Chinese companies take market share from multinationals in China in some high-risk implantable device categories, FDA's device representative in Beijing says the agency expects to see made-in-China class III devices enter the U.S. Chinese manufacturers, however, face a number of hurdles before this can become reality.
About 4,000 China-based medical device makers are registered with FDA. Right now, these companies export lower-risk class I and II devices to the U.S. market. But FDA expects class III devices from China on the U.S. market, according to William Sutton, deputy director of industry and consumer education at CDRH.
Currently serving on a detail assignment as an International Program and Policy Analyst for Medical Devices in China, Sutton went...
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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.
While HistoSonics is awaiting the CE mark in Europe, it hit a major milestone by securing early limited market access in Great Britain under a Unmet Clinical Need Authorization (UCNA), bringing its noninvasive histotripsy treatment to patients with liver tumors.
Manufacturing shifts, financial planning, and supply chain changes are among the adjustments that medtech leaders are making to Trump-era tariffs. Medtech Insight’s review of first-quarter earnings calls reveals how firms are navigating the impact and uncertainty of evolving trade policies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
