Private placement raises over $30 mil. to help support a modular premarket approval application for the company's thermal breast cancer detection system, as well as additional "industrial medical" applications of the technology. The thermal breast imaging system is intended as an adjunct to mammography (1"The Gray Sheet" April 19, 1999, p.23)
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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.
Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.
Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.
The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.
