Prescription device labeling would be allowed to state "Rx only" in place of the currently required legend: "Federal law restricts this device to sale by or on the order of a [type of licensed practitioner]," under guidance currently being drafted, agency staffers say. The change, which the FDA Modernization Act allowed for drugs, was advocated for devices in a March 1 citizen petition filed on behalf of the Contact Lens Institute. The Rx symbol facilitates "a less cluttered label and international uniformity and simplicity," the petition states. FDAers note that the labeling change likely would not apply to in vitro diagnostic devices, which are subject to separate regulation
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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.
GE HealthCare is pursuing a dual-front imaging strategy with its PET MIP agent Flyrcado for detecting artery disease: It lasts longer than current PET scan tracers and allows patients to do treadmill-based stress tests alongside the scan.
DeepLook Medical recently announced the commercial rollout of DL Precise, an AI-powered imaging platform that enhances breast cancer screening, at major healthcare institutions across the US.
Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.
