Investigational devices from CreatiVasc Medical, Blood Purification Technologies and the University of California, San Francisco were selected for CDRH’s “innovation pathway 2.0” program.
The three device candidates selected by CDRH for its “innovation pathway 2.0” program each pursue a different treatment approach for end-stage renal disease, but they are all still in the early stages of development.
FDA’s device center announced April 9 the launch of the next stage of the pilot program for hyper-collaboration between sponsors...
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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.
