Four years following FDA approval, Lucentis remains the standard of care for the treatment of neovascular (wet) age-related macular degeneration (AMD) and has been widely adopted for
off-label treatment of other retinal diseases. Companies are pursuing new drugs that may have more
favorable dosing profiles, device-based technologies that may reduce the dosing frequency of Lucentis, and implantable drug delivery vehicles designed to deliver drugs to the back of the eye that may be applicable to a broad range of retinal therapies.
by Michael Lachman
Four years following Food & Drug Administration (FDA) approval of the anti-VEGF (vascular endothelial growth factor) drug ranibizumab ( Lucentis) from Genentech Inc./Roche, this new drug class remains...
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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.
The imaging, Varian, and advanced therapies segments – which are more reliant on equipment sales – are more heavily affected, with tariffs applying to roughly 55% of their revenue base. In diagnostics, the company expects minimal exposure due to sufficient US value-added manufacturing.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
