DAILY WEAR CONTACT LENS 510(K) GUIDANCE WILL ALLOW ACCELERATED AGING studies to be used to establish contact lens shelf life of beyond two years, David Whipple, associate director for contact lenses in FDA's Division of Ophthalmic Devices, said at a March 22 meeting of the agency's Ophthalmic Devices Panel in Bethesda, Maryland. Whipple noted that the agency received a "significant number of comments from manufacturers" objecting to the two year aging study limitation proposed in FDA's November 1993 draft guidance on 510(k)s for daily wear plastic contact lenses ("The Gray Sheet" Nov. 29, 1993, p. 8).
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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.
CEO Alexandre Chau told Medtech Insight that the Middle East and Africa presented the ideal mix of market potential, physician training opportunities, and regulatory readiness when the company was considering expansion markets beyond Europe and the US.
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
