Democratic Caucus of the House Energy and Commerce Committee announces subcommittee assignments for the 111 Congress, following the takeover of the chairmanship of the full committee by Rep. Henry Waxman, D-Calif., from Rep. John Dingell, D-Mich., in November ("1The Gray Sheet" Nov. 24, 2008, p. 5). Rep. Frank Pallone, D-N.J., will retain his chairmanship of the Health Subcommittee, which handles most FDA-related legislation, and Bart Stupak, D-Mich., who has been trying to persuade the incoming Obama administration to "clean house" at FDA, will retain his chairmanship of the Oversight and Investigations subpanel. Stupak sent a letter in December to the Obama transition team, asking, among other things, that no current senior FDA employee be put in charge of the agency, even on an interim basis ("2The Gray Sheet" Dec. 15, 2008, p. 23)
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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 NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.
The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.
“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.
