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Starts & Stops: Mercator Looking To Leap Into New Indications For Bullfrog Micro-Infusion Drug-Delivery
Starts & Stops is a regular feature highlighting Medtech Insight's monthly editors' picks of noteworthy medtech clinical trial announcements, initiations, completions, and suspensions. This month's edition, covering November, is led by a major milestone for Mercator Medsystems, developer of the Bullfrog micro-infusion catheter.
Latest From Clinical Trials
Starts & Stops is a regular feature highlighting Medtech Insight's monthly picks of noteworthy clinical trial announcements, initiations, completions, and suspensions. The list for December is headlined by announcements on Edwards' transcatheter valve technologies. Meanwhile, MValve, a company Boston Scientific has invested in, is not going forward with a planned trial of its MValve dock device with Boston Scientific's Lotus valve now that Lotus is off the market.
A proposed coverage policy from the US Centers for Medicare and Medicaid Services would not only cover magnetic resonance imaging for patients with an implanted cardiac rhythm management device with an FDA-approved indication for MRI-compatibility, but will also cover MRI in patients with devices without that FDA labeling in certain circumstances.
Even though the new EU Medical Device Regulation marks a “very important advancement,” it still falls short when it comes to requirements on generating clinical evidence, according to a study conducted in Germany.
Swedish company Sensori received a ringing endorsement from results of a clinical placebo study evaluating the use of its Antinitus patch to treat tinnitus. Results from the study were published in the scientific journal The International Tinnitus Journal.
US FDA cleared the Sidus total shoulder arthroplasty system for patients with "good bone stock" who have osteoarthritis, posttraumatic arthrosis, focal avascular necrosis of the humeral head, or a previous shoulder surgery that does not compromise the fixation. The company is planning to launch it in the US by the end of the quarter.
Intragastric balloon-maker Allurion is making some major changes in its executive suite to support its plan to expand its market reach.
Myriad Genetics, Lumicell, and Agendia were among the companies with diagnostic technologies featured in the scientific presentations at the recent San Antonio Breast Cancer Symposium. New trials show that Myriad's EndoPredict can help identify patients who should not have preoperative chemotherapy. New Phase II data support Lumicell's LUM system for guiding excision of residual tumor and preventing cancer recurrence. Agendia's MammaPrint test proved cost-effective in the MINDACT trial.
In another step to make its work more patient-friendly, US FDA is recruiting members for a patient advocacy group that will focus on medical product development.
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