Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.
After over a decade of development, two major clinical trials and three FDA advisory panels, Boston Scientific Corp.’s Watchman is finally set to reach the U.S. market. FDA approved the PMA for the left-atrial appendage closure device to prevent stroke in some patients with atrial fibrillation on March 13.
FDA and its advisors reviewing the device's data over the years struggled to identify exactly which patients it benefits. But...
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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.
The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.
Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.
The Modern Industrial Strategy is the first of this summer’s UK blueprints for supporting life sciences industrial activity and transforming NHS healthcare delivery. The UK market must also benefit from its own innovation activity, says industry.
