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Medtech Insight’s Shawn M. Schmitt talks about Part 4 of “Medtech’s Next Top Maturity Model,” his feature series on the appraisal of device-makers’ manufacturing capability and maturity. This episode focuses on appraisers affiliated with Pittsburgh's CMMI Institute and describes the hurdles they must clear to be part of a US FDA pilot program that uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) framework.
In this edition of the Device Week podcast, Medtech Insight’s Reed Miller talks about the latest good news for LivaNova and Catherine Longworth provides an update on Creavo Medical, a UK-based company using an old technology for a new kind of cardiac test that could save hospitals money.
On this week’s podcast, Medtech Insight’s Ferdous Al-Faruque and Shawn M. Schmitt discuss “The Bleeding Edge,” a new Netflix documentary by Oscar-nominated director Kirby Dick that is highly critical of the medical device industry and US FDA.
The medtech industry’s No. 1 player, Medtronic, is the focus of this edition of Device Week, as the firm hit the headlines with some impressive first fiscal quarter results and positive data from a trial of its Synchromed II drug infusion pump. Medtech Insight’s Reed Miller and Tina Tan chat about what helped to boost the company’s top- and bottom-lines and delve deeper into the SISTERS trial for Synchromed and the impact these results will have on the company’s pain management business.
On this week’s podcast, Medtech Insight’s Shawn M. Schmitt talks about his recent reporting on US FDA’s plans to merge its bedrock rule for manufacturing safe and effective devices in the United States with international quality systems standard ISO 13485.
On this week's podcast, Medtech Insight's Reed Miller talks to Marion Webb about her latest two-part Market Intelligence series on the liquid biopsy market.
On this week’s podcast, Medtech Insight’s Catherine Longworth and Ferdous Al-Faruque talk about surgical guidance company Endomag, which recently secured a landmark approval from US FDA for its combination breast cancer product Sentimag and Magtrace.
In this edition of Device Week, Medtech Insight’s Tina Tan finds out more about the fast-growing market for surgical ablation devices to treat cancer. Marion Webb gives an insight into the speed at which the market is expanding and who are the emerging innovators. Catherine Longworth then discusses in more detail one of the more established players in this field – Medtronic – which has installed its Visualase system in the UK for the first time after getting a CE mark recently.
On this week's podcast, Reed Miller talks about the Medicare Evidence Development & Coverage Advisory Committee's recent gathering to discuss transcatheter aortic valve replacement coverage policies, and the debate over hospital and physician volume requirements.
In this edition of Device Week, Medtech Insight’s Tina Tan discusses trends in VC financing and M&A activity for medtech in 2018. David Filmore explains US FDA’s latest approvals numbers, and Reed Miller talks about the state of medical device approvals outside the US.
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