Results published in the June 22 New England Journal of Medicine suggest that condoms effectively reduce the risk of human papillomavirus (HPV) transmission. Investigators Rachel Winer, PhD, University of Washington, et al., report that women whose partners used condoms for all instances of intercourse over an eight-month period were 70% less likely to acquire a new infection than women whose partners used condoms less than 5% of the time. None of the women who reported always using condoms developed HPV lesions during the study period. Data also suggests that condom use aids in the prevention of high-grade cervical neoplasia and invasive cervical cancer, but larger data sets are needed to confirm these trends, the authors say. The investigation sheds light on questions raised by Congress about the accuracy of condom labeling for HPV and other sexually transmitted diseases (1"The Gray Sheet" Nov. 14, 2005, p. 17)...
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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.
Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.
With new regulations limiting the use of plastics popping up worldwide, the medtech industry sees arguments on both sides. Some argue hasty bans of PFAS ("forever chemicals") would harm patients, while others say phthalates should be phased out to protect the public.
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
