FDA is proposing to require pre-market approval applications for three class III, pre-amendment device types in the cardiovascular and neurologic device spaces.
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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.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.
