Guidant ICDs: Three deaths have now been associated with clinical failures of Guidant's Contak Renewal and Renewal 2 implantable cardioverter defibrillators that were manufactured on or before Aug. 26, 2004, according an 1Oct. 13 Preliminary Public Health Notification from FDA. The notice updates a July 14 agency communication about malfunctions with the Renewal products as well as the Ventak Prizm 2 ICDs, which led to a Class I recall (2"The Gray Sheet" June 20, 2005, p. 19). Guidant has reported a total of 49 instances of these ICDs exhibiting the specified failure mode...
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
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.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
