FDA To Draft “Straw Man” Mobile Health App Guidance With Industry Help
FDA intends to release draft guidance on mobile health applications later this year to help gather feedback as it creates a more comprehensive mHealth regulatory policy, but not without industry input.
More from Archive
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.
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.
More from Medtech Insight
Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.
Only 14% of people with type 2 diabetes use continuous glucose monitors, although 93% of users report a positive impact on their health. Dexcom is ramping up efforts to close this adoption gap.
ChestView, Gleamer’s newly FDA-cleared solution, is designed for chest X-ray interpretation and is the latest addition to its Gleamer Copilot suite. ChestView, which operates as a computer-aided detection system that can simultaneously detect multiple pathologies on images to support radiologists, is being rolled out in the US.