The Medicare agency is requesting public comment on the clinical evidence of short-term and long-term health benefit outcomes of this procedure to diagnose and treat lumbar spinal stenosis.
CMS opened a national coverage analysis
April 5 for percutaneous image-guided lumbar decompression for lumbar spinal stenosis.
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The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
