Expanded indication for the colon cancer detection tool gains 510(k) clearance, supporting a claim for increased detection of cancerous and pre-cancerous polyps in the colon when used in conjunction with colonoscopy, the firm announces Feb. 17. The device, initially cleared in April 2007, provides physicians a backward view of the colon that complements the forward view of the colonoscope to help them visualize blind spots in the colon where cancers may be hiding, the firm explains. The Sunnyvale, Calif.-based company recently raised $10 million in a "Series C" financing to help fund a rollout of the device this year, as well as to establish U.S. centers of excellence to facilitate the launch, to collect additional data supporting clinical utility, and for sales and marketing efforts (1"The Gray Sheet" Jan. 26, 2009, p.20)
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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.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
