Citeline Podcasts

This week Gray Sheet journalists discussed a new report from the FDA-sanctioned Medical Device Registry Task Force, feedback to FDA on patient-preference data, MRI compatible device launches in Europe, the Abbott-St. Jude acquisition rumor and more.

This week Gray Sheet journalists discussed a new report from the FDA-sanctioned Medical Device Registry Task Force, feedback to FDA on patient-preference data, MRI compatible device launches in Europe, the Abbott-St. Jude acquisition rumor and more.

Positive data from five clinical trials and new treatment guidelines for mechanical thrombectomy devices have ushered in a new era in stroke care. Medtech Insight sat down with Brett Wall, Vice President and President of Medtronic Neurovascular at the recent SNIS meeting, to find out what impact the trials and guidelines are having on stroke care, the market for mechanical thrombectomy devices, demand for Solitaire FR, and the company's plans for innovation. Read more at: https://www.pharmamedtechbi.com/a/2015700099

Positive data from five clinical trials and new treatment guidelines for mechanical thrombectomy devices have ushered in a new era in stroke care. Medtech Insight sat down with Brett Wall, Vice President and President of Medtronic Neurovascular at the recent SNIS meeting, to find out what impact the trials and guidelines are having on stroke care, the market for mechanical thrombectomy devices, demand for Solitaire FR, and the company's plans for innovation. Read more at: https://www.pharmamedtechbi.com/a/2015700099

Positive data from five clinical trials and new treatment guidelines for mechanical thrombectomy devices have ushered in a new era in stroke care. Medtech Insight sat down with Brett Wall, Vice President and President of Medtronic Neurovascular at the recent SNIS meeting, to find out what impact the trials and guidelines are having on stroke care, the market for mechanical thrombectomy devices, demand for Solitaire FR, and the company's plans for innovation. Read more at: https://www.pharmamedtechbi.com/a/2015700099

This week, "Gray Sheet" journalists discuss a three-day meeting of the International Organization for Standardization (ISO) to hammer out a final draft of the long-awaited revision of the international quality systems standard ISO 13485, two FDA pilot programs to create a new transparent device malfunction database and a new globally harmonzied marketing submission system, and new agency requirements when testing stents made with nickel.

This week, "Gray Sheet" journalists discuss a three-day meeting of the International Organization for Standardization (ISO) to hammer out a final draft of the long-awaited revision of the international quality systems standard ISO 13485, two FDA pilot programs to create a new transparent device malfunction database and a new globally harmonzied marketing submission system, and new agency requirements when testing stents made with nickel.

This week, "Gray Sheet" journalists discuss a three-day meeting of the International Organization for Standardization (ISO) to hammer out a final draft of the long-awaited revision of the international quality systems standard ISO 13485, two FDA pilot programs to create a new transparent device malfunction database and a new globally harmonzied marketing submission system, and new agency requirements when testing stents made with nickel.

This week, "Gray Sheet" journalists discuss the start of the electronic adverse event reporting requirement, where all the device warning letters have gone, an update on early user-fee reauthorization discussions and more.

This week, "Gray Sheet" journalists discuss the start of the electronic adverse event reporting requirement, where all the device warning letters have gone, an update on early user-fee reauthorization discussions and more.