Discrete premarket submissions should be required for reprocessed single-use devices made by different original equipment manufacturers, AdvaMed states in Jan. 22 comments on CDRH's "bundling" policy
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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.
Innovative Healthcare is asking for a permanent injunction against Johnson & Johnson subsidiary Biosense Webster after winning a $442 million antitrust verdict. The injunction aims to prevent continued anticompetitive practices in the electrophysiology catheter market.
Point of care ultrasound technology that can be used by non-sonographers will plug gaps in workforce coverage and bring new critical care capabilities to the frontline of care, said Royal Philips.
The new AI Precision Medicine platform supports the company’s flagship product, EvoLiver, which received US FDA breakthrough device designation in April.
