MiCardia has a new twist on annuloplasty for mitral regurgitation; Biosifica Inc.'s disposable dressing delivers electrical stimulation to a wound bed to encourage healing. Mobius Therapeutics aims to bring control and convenience to glaucoma surgery with an easy to use mitomycin C kit.
by Mary Stuart
In medical devices, one size rarely fits all, and when it come to the type of heart valve disease that...
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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.
CMS is proposing to classify all CGMs and insulin pumps as “items requiring frequent and substantial servicing” to expand device choice and access for Medicare beneficiaries. Under this framework, CMS also intends to move Class II devices, which include CGMs from Abbott and Dexcom and pumps from Tan
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
