The procedure, aimed at treating lumbar spinal stenosis, is not reasonable and necessary, the Medicare agency says. A final decision is due Jan. 15.
An Oct. 17 proposed
decision by CMS states that percutaneous image-guided lumbar decompression for lumbar spinal stenosis is not reasonable and necessary and should...
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Berlin medtech associations add to European voice requesting that the EU eases MDR/IVDR and other compliance costs on SMEs.
A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.
Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.
Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.
Urgent action is needed to address gaps in how risks from medical devices and diagnostics utilizing AI are identified, mitigated and managed. So says James Pink, renowned medtech regulatory expert in an interview with Medtech Insight.
The US FDA has published a list of recommendations for the safe use of hyperbaric oxygen therapy devices. While the therapy can be effective in treating several conditions, the agency says providers need to understand its potential risks.
