Conventional endometrial ablation, commonly referred to as "rollerball" ablation used to treat menorrhagia, often entails pretreatment by loop resection, but can be performed without resection, according to the FDA. Novacept initially had indicated that ablation with its NovaSure was faster than rollerball ablation because it did not require resection(1"The Gray Sheet" Oct. 15, 2001, p. 6). However, the 90-second average treatment time demonstrated in the 265-patient trial of the NovaSure is shorter than rollerball ablation with or without resection, according to the agency. Also, the FDA's internal standard for endometrial ablation devices requires that their success rate cannot be 20 percentage points worse than that of the control with a 95% confidence interval, not 80% as successful, as was reported. In the trial submitted in February, the NovaSure slightly exceeded the success rate of the control, but the difference was not statistically significant. Novacept was required to follow up patients from the original study for three years - the same postmarket requirement agreed to by BEI Medical and Ethicon following approval of the Hydro ThermAblator and ThermaChoice, respectively...
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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.
Annual survey of patients and professionals shows how attitudes to health system transformation are evolving and what stakeholders are demanding as acceptance of AI tools accelerates.
Thermo Fisher is aggressively managing its supply chain and cost base using its Practical Process Improvement (PPI) Business System. The company is also increasing investments in US-based manufacturing and R&D, with around $2bn allocated to bolster domestic operations.
FDA moves forward with implementing previous draft guidance and will consolidate forms, but the agency estimates limited impact in the total reporting burden.
