FDA approval of firm's NIRoyal coronary stent mounted on a Monorail delivery system via premarket approval application supplement allows for release of first gold-coated stent in the U.S., the company reports May 25. Available in lengths 9, 12, 15, 18, 25 and 31 mm and diameters of 2.0-4.0 mm in 0.5 mm increments, the device provides enhanced visibility over currently available stents, the firm claims. The product, which is said to have been delayed in gaining final agency go-ahead, is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete (de novo) lesions in native coronary arteries (length equal to or less than 25mm) with a reference vessel diameter of 3.0 - 4.0 mm; treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5-4.0 mm; and patients with symptomatic heart disease due to lesions in saphenous vein bypass grafts with lesion length equal to or less than 30 mm and reference diameter in the range of 3.0-4.0 mm. The firm's gold-coated NIRoyal Elite stent, which includes the SOX securement system, is pending FDA approval
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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.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
