Thoratec reported a near 10 percent year-over-year decline in revenue in the second quarter; physicians have become more selective about which patients to implant with a HeartMate II ventricular assist device, the firm says. The company is looking to next-generation of HeartMate products as well as the technology it acquired in the Apica deal to help it return to growth.
Thoratec Corp. is counting on its future product pipeline, especially HeartMate III and HeartMate PHP, to drive revenue growth in its struggling flagship HeartMate ventricular assist device business.
On August 6, the company reported $118.1 million in revenue for the second quarter of 2014, a year-over-year drop of...
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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.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
