Recent reports questioning the benefits of early prostate cancer diagnosis and treatment have raised an industry-wide debate that has been fueled by the limitations of prostate-specific antigen tests, currently the standard of care for early prostate cancer detection. While the industry searches to improve the use of PSA tests, urologists are asking, "are we over treating our patients?" That question was repeatedly voiced in a number of forums at the American Urological Association's 2010 Annual Meeting. As for a definitive answer to the question, it is a somewhat difficult task to get individual physicians to admit they are personally over treating patients; however, there is definitely a consensus-and a concern-that more patients than necessary are receiving treatments that put them at risk of serious side effects.
by Robert Neil
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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.
Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
Medtronic says results from a recent study on the Hugo robotic-assisted surgery system substantiate its safety and effectiveness for various urological procedures. The company also announced it has submitted the system to the FDA for approval for a urological indication.
FDA Commissioner Marty Makary stated in a new interview that there will be no significant reorganization of the agency, despite earlier reports. Using his “guiding principles” of common sense and gold-standard science, he plans to focus on reforms including improved pathways for medical AI and food safety as well as addressing employee morale.
