Firm initially will pursue diagnostic imaging claim for its PillCam Colon 2 video capsule, rather than a screening claim, as the fastest route to U.S. market. The strategy shift follows preliminary clinical trial data review.
Given Imaging Ltd. plans to pursue 510(k) clearance for its PillCam Colon 2 video capsule for diagnostic imaging of the colon, rather than for screening, as the fastest route to the U.S. market, the firm announced Aug. 8 during its second quarter earnings call.
While a broader screening indication has been a goal of the company, Given Imaging says that after reviewing most of...
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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.
Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
