Regulatory News In Brief
FY 2011 user fees: FDA publishes device user fee rates for fiscal year 2011 in an Aug. 3 Federal Register 1notice. The rates increase by about 8.5% each year, as required by statute. The FY 2011 standard fee for a pre-market approval (PMA) application is $236,298, or $59,075 for small businesses. 510(k) submission fees are $4,348, or $2,174 for small businesses. All establishments must pay a $2,179 annual registration fee, with no discount for small businesses. The updated fees apply to applications received from Oct. 1, 2010, through Sept. 30, 2011
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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.
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Dexcom announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.
Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?