Ethicon Endo-Surgery's anaesthetic delivery system, Sedasys, is set for a second FDA advisory panel review after the agency granted an appeal from the company.
Ethicon Endo-Surgery's anaesthetic delivery system, Sedasys, is set for a second FDA advisory panel review after the agency granted an appeal from the company.
The Johnson & Johnson subsidiary filed the appeal in March after the FDA issued a not-approvable letter for the device,...
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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.
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
Exact Sciences has entered into an exclusive licensing agreement with Freenome, stipulating clinical benchmarks and a first-line rating in the USPSTF guidelines. Medtech Insight interviewed screening CMO Paul Limburg about CRC screening and Exact’s strategy on liquid biopsy.
