Dexcom Inc. posted a 19% increase in first quarter revenues compared to 2022 boosted by a stunning 27% organic growth in sales outside the U.S. With clearance of the G7 device in hand, another record set in new patient starts and coverage of continuous glucose monitoring (CGM) systems by CMS effective this month, the year is shaping up to be quite rosy for the diabetes device company.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
The 10-year update to Medtronic plc’s ENGAGE registry for its Endurant abdominal aortic aneurysm (AAA) stent graft system demonstrated high degrees of protection from aneurysm and sac regression in a real-world setting. The results were presented at the 2023 Charing Cross Symposium in London on April 26.
The gastroenterology team at the Paoli-Calmettes Institute in Marseille, France is conducting a therapeutic trial using G-Eye, the latest generation of colonoscope from Hanofar, Israel-based Smart Medical Systems Ltd. “The aim is to increase the detection rate of polyps thanks to a new type of device that can be connected to the current colonoscopes on the market,” Jean-Philippe Ratone, the principal investigator of the study and gastroenterologist at the Paoli-Calmettes Institute told BioWorld.
Two tough years have taken a toll on Medtronic plc with a warning letter for its diabetes unit, a reorganization that will spin off its respiratory, patient care and renal groups and layoffs of an undisclosed number of employees that began last week. The announcement late Friday of the U.S. FDA approval of the Minimed 780G insulin pump system could be a turning point for the company that brings it back into the competition for the growing diabetes market.
The U.S. CMS has a few changes in mind for the new technology add-on program (NTAP) for fiscal year 2024, including a proposal to allow manufacturers to apply for an NTAP payment only after the sponsor has filed a completed premarket application with the FDA. Perhaps more significantly, the deadline for FDA approval would also be moved up earlier in the calendar year, from July 1 to May 1, a change that could eliminate a year of NTAP eligibility for a significant number of products.
Medtronic plc and Davita Inc. launched a new company this week centered on the assets and capabilities of Medtronic’s former Renal Care Solutions (RCS) division. Mozarc Medical US LLC brings Medtronic’s strategic plan to streamline its operations by spinning off several divisions one step closer to fruition.
Medtronic plc has announced a plan by Cosmo Pharmaceuticals NV and Nvidia Inc. to integrate Nvidia's artificial intelligence (AI) technologies into Medtonic’s GI Genius intelligent endoscopy module. GI Genius is designed to host multiple AI algorithms as the first U.S. FDA-cleared, AI-assisted colonoscopy imaging tool for detecting polyps that can lead to colorectal cancer.
As Medtronic plc. is fond of pointing out, the garage inventor has been the stuff of legend in U.S. business lore, providing a wide range of economically impactful inventions over the two-plus centuries since the U.S. patent system came into being.
Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
