New drug application for the firm's 13C urea-based solution included in the Pylori-Chek test kit is undergoing FDA review despite a four-year exclusivity clause granted by FDA to Meretek for its Pranactin combination device/drug system for detection of H.pylori infection in the digestive system, Alimenterics says. On March 13, Meretek filed a petition with FDA requesting a stay of approval of all pending NDAs for 13C urea-based H.pylori tests because it had gained exclusivity from the agency. In an April 7 response to the petition, Alimenterics asserts that the Pylori-Chek is not subject to the exclusivity clause "because the NDA submitted by Alimenterics was a 'full' NDA." Meretek's Sept. 17 Pranactin approval was supported by an abbreviated NDA, Alimenterics explains. In addition to the 13C urea-solution, the Pylori-Chek consists of the 510(k)-cleared LARA non-radioactive carbon urea breath test and a breath collector device. "The Gray Sheet" (March 23, In Brief) incorrectly stated that the LARA breath test is a radioactive carbon urea test
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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.
Openwater is currently focusing on EMS applications of its AI-powered stroke detection technology, both in-hospital and prehospital, such as in ambulances and urgent care centers.
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Ahead of the ADA conference, Abbott announced Tandem as the fourth partner to integrate Abbott’s dual glucose-ketone sensor with automated insulin delivery. Expanded Medicare CGM coverage, FDA label expansions and new ADA guidelines position Abbott to grow its CGM footprint in a competitive market.
