CMS updates coverage policy on PET for cervical cancer: The Medicare agency finds there is now enough evidence to call positron emission tomography for cervical cancer "reasonable and necessary" for staging cervical cancer patients, and will no longer require data collection as a condition of coverage (1"The Gray Sheet" May 18, 2009). CMS will cover one PET scan for staging beneficiaries with biopsy-proven cervical cancer to help determine the location or extent of the tumor. Coverage is limited to the following therapeutic uses: to determine if the patient is a good candidate for an invasive diagnostic or therapeutic procedure; to determine the best anatomic location for an invasive procedure; or to determine the anatomic extent of a tumor when treatment depends on the extent of the tumor. The imaging test remains non-covered as a tool to diagnose cervical cancer. This recent decision does not restrict the use of PET scans already covered for detection of metastases during the pre-treatment management phase of patients with newly diagnosed and locally advanced cervical cancer who show no extra-pelvic metastasis on conventional imaging tests such as CT or MRI (2"The Gray Sheet" April 13, 2009)
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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.
After receiving FDA clearance for its Genio sleep apnea implant, Nyxoah plans a major US rollout despite a patent suit from rival Inspire Medical. Genio offers bilateral nerve stimulation as a CPAP alternative, with strong trial results.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.
