San Diego diagnostics firm Gen-Probe begins a 7,000-patient U.S. pivotal trial in late March of its Aptima molecular assay to detect human papillomavirus (HPV). The amplified nucleic acid test detects 14 high-risk HPV types associated with cervical cancer. One arm of the multi-center clinical study will enroll women whose Pap results are classified as atypical squamous cells of undetermined significance (meaning they are neither normal nor clearly indicative of progression to cervical cancer), and the other arm will enroll women over age 30 with normal Pap results. Qiagen/Digene (Hybrid Capture 2) offers the only FDA-approved molecular assay for HPV, but a number of competitors are seeking market entry (1"The Gray Sheet" Jan. 21, 2008, p. 22)
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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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
EU member states have issued a consensus statement on the urgent need to build momentum to tackle governance and centralization issues as part of much-needed reform of the EU medtech regulatory system.
A deep-learning AI-based retinal image scanning tool can predict the risk of cardiovascular events over a 10-year period with 70% accuracy. The test is comparable to routine GP health checks, researchers from the University of Dundee have shown.
