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BioWorld - Saturday, July 4, 2026
Home » Medtronic plc

Articles Tagged with ''Medtronic plc''

Architectural pillars

Medtronic takes beef with Axonics to the US ITC

March 5, 2024
By Mark McCarty
Medtronic plc and Irvine, Calif.-based Axonics Inc. have been locked in a struggle over several patents in the past few years, but now Medtronic has shifted some of its effort from the U.S. courts to the executive branch.
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Biosense Webster VARIPULSE LA Map

Biosense Webster continues PFA approval trend, nabs CE mark for Varipulse

Feb. 29, 2024
By Annette Boyle
Continuing the spate of regulatory approvals for pulsed field ablation (PFA) devices around the world, Johnson & Johnson’s Biosense Webster Inc. unit secured CE mark for the Varipulse platform for treatment of symptomatic, drug-refractory recurrent paroxysmal atrial fibrillation.
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MIRA Virtual Incision

Virtual Incision’s miniature robotic surgery device gets FDA nod

Feb. 26, 2024
By Annette Boyle
The U.S. FDA granted Virtual Incision Corp. de novo marketing authorization for its miniaturized in vivo robotic assistant for use in colectomy procedures in adults. The two-pound device offers portability and quick setup, eliminating the need for specialized operating rooms or arrangements to accommodate robotics.
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FDA icons and doctor

FDA still undecided on the use of silicone in endotracheal tubes

Feb. 23, 2024
By Mark McCarty
The U.S. FDA issued an update to a previous advisory to doctors regarding the use of electromyogram endotracheal tubes made by Dublin-based Medtronic plc., but there is still some noise in the agency’s communications regarding this matter.
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Boston Scientific Wavewriter Alpha spinal cord stimulation system

Boston Sci’s Wavewriter surfs to FDA approval for non-surgical back pain

Feb. 8, 2024
By Annette Boyle
Boston Scientific Corp. notched another win with the U.S. FDA approval of its spinal cord stimulator (SCS), Wavewriter, for treatment of non-surgical back pain just a week after receiving the agency’s nod for its Farapulse pulsed field ablation system. The new indication comes four months after expansion of approved uses for Wavewriter to include painful diabetic peripheral neuropathy.
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Esophageal cancer

Cyted gets FDA approval for capsule sponge device

Feb. 6, 2024
By Shani Alexander
Cyted Ltd. received U.S. FDA 510(k) clearance for its Endosign capsule technology, a non-endoscopic capsule sponge device used to collect pan-esophageal samples to detect esophageal pre-cancer and other conditions. The company believes that the minimally invasive test will be able to help prevent deaths from esophageal cancer when offered as a screening test to people on long-term medication for heartburn.
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Edwards EVOQUE

Edwards pumped about Evoque US tricuspid valve replacement approval

Feb. 2, 2024
By Holland Johnson
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
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FARAPULSE pulsed field ablation system

Boston Sci’s Farapulse approval intensifies PFA competition

Jan. 31, 2024
By Annette Boyle
The U.S. FDA added a second pulsed field ablation (PFA) system to the approved list with its greenlight for Boston Scientific Corp.’s Farapulse for treatment of atrial fibrillation (AF). Farapulse joins Medtronic plc’s Pulseselect, which garnered FDA approval in December. Two other PFA devices scored regulatory wins since the new year: Biosense Webster inc.’s Varipulse secured approval from the Japanese Ministry of Health Labor and Welfare and Sichaun Jinjiang Electronic Medical Device Technology Co. Ltd. got the nod from China’s National Medical Products Administration.
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LIBERTA DBS

FDA frees Abbott’s Liberta RC DBS system for use

Jan. 25, 2024
By Annette Boyle
Abbott Laboratories received U.S. FDA approval for its Liberta RC deep brain stimulation (DBS) system for use in movement disorders, less than two weeks after the agency gave its nod to Medtronic’s Percept RC DBS system. The news come on the heels of Abbott’s release of strong fourth quarter results on Wednesday.
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First PFA device granted NMPA approval in China

Jan. 12, 2024
By Pankhil Paresh and Zsuzsa Lindenmaier
Sichuan Jinjiang Electronic Medical Device Technology Co. Ltd. received approval from China’s National Medical Products Administration (NMPA) approval for the commercial use of its PFA technology in the treatment of atrial fibrillation, making it the first pulsed field ablation device to gain approval in the country.
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