Over the past 20 years, the diagnosis of esophageal adenocarcinoma - the most common form of esophageal cancer - has doubled in the US and now stands at roughly 16,500 new cases each year. This dramatic increase is believed to be related to an increased incidence of gastroesophageal reflux disease (GERD) and obesity. Physicians agree that to slow the increase in this deadly cancer, detection at its earliest stages is critical. Unfortunately, the standard tools available to do this are less than ideal. NinePoint Medical has developed technology designed to detect precursors to esophageal cancer in real time, in vivo, using near-infrared light and complex computing algorithms.
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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.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
