LASIK Panel Reaches Consensus On Labeling Changes
Patient labeling for LASIK laser vision correction systems should be modified to include graphics of what potential visual side effects like halos and starbursts could look like, according to FDA's Ophthalmic Devices Panel
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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.
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A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
Through this partnership, data stored in LibreView – Abbott’s cloud-based diabetes data management system – can automatically flow into Epic, allowing clinicians using Epic to view a patient’s CGM data before, during and after visits without toggling between systems or requesting manual uploads.