Abbott predicts slow CGMS uptake: Abbott/TheraSense's FreeStyle Navigator continuous glucose monitor system (CGMS) is expected to experience a "gradual build-up" in the diabetes market upon FDA approval, since diabetics "have a fair amount of loyalty to their monitors and to their strip technology," CFO Thomas Freyman tells Banc of America Securities Health Care Conference attendees May 19 in Las Vegas. The system will "probably make the most inroads with newer diabetics." Abbott previously predicted approval of its November 2003 PMA submission by early 2005; competitors will include Medtronic's approved Guardian CGMS (1"The Gray Sheet" Feb. 16, 2004, p. 14)...
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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.
In Vivo spoke to the previous commissioner of the US FDA about recent ongoings at the agency, and where he believes policy should be directed for patient and industry benefit.
After publishing encouraging results from first-in-human trials of its brain-computer interface, Axoft announced plans to sell its BCI-enabling material Fleuron to researchers and private organizations for R&D use. The company sees this as a revenue stream and feedback loop to refine its BCI platform designed for safer, longer-lasting brain implants.
Roche’s Indianapolis site currently produces 5.2 billion Accu-Chek test strips annually and supports distribution to 53 countries. The new CGM line will add to an already diversified operational footprint, which includes R&D, laboratories, manufacturing, and IT services.
