Nine years after it won the CE Mark in Europe, the Neovasc (NSDQ:NVCN) Reducer device, designed to treat refractory angina, is close to an FDA decision on premarket approval. The agency’s Circulatory Systems Devices Panel is scheduled to discuss the Reducer at a virtual meeting set for Oct. 27, the FDA announced today. In a […]
FDA approves Medtronic MiniMed 770G insulin pump for young children
The FDA has approved the Medtronic (NYSE:MDT) MiniMed 770G hybrid closed loop-diabetes management system for Type 1 diabetes patients aged 2 to 6 years. The MiniMed 770G is the first-of-its-kind system that can automatically adjust insulin delivery based on continuous glucose monitor values for such young children, according to the agency. The FDA approved an earlier MiniMed […]
TransMedics to get its virtual day with FDA panel on heart transplant tech
After a six-month pandemic-related delay, TransMedics (NSDQ:TMDX) is set to have an FDA panel review the premarket approval application for its donor heart transport technology on October 7, 2020. TransMedics’ organ care system (OCS) technology is designed to keep donated hearts, lungs and livers in near-living condition until transplantation. The FDA approved the Andover, Mass.-based company’s […]
FDA approves Edwards Lifesciences’ ready-to-implant aortic valved conduit
Edwards Lifesciences (NYSE:EW) announced today that FDA has approved its Konect Resilia aortic valved conduit (AVC). Edwards describes the Konect Resilia as the first ready-to-implant option for bio-Bentall procedures, a complex surgery that involves the replacement of a person’s aortic valve, aortic root and the ascending aorta. Surgeons find themselves having to perform nearly a third […]
Axonics’ SNM system wins FDA nod for 3T-MRI scans
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system. The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental […]
FDA approves Medtronic’s latest DBS
Medtronic (NYSE:MDT) said today that it has received FDA approval for the Percept PC deep brain stimulation (DBS) system. The medical device giant is touting Percept PC’s BrainSense technology, which is designed to sense and record brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease. BrainSense enables more personalized, […]
Philips wins FDA approval for new automated external defibrillators
Royal Philips (NYSE:PHG) announced today that FDA has granted premarket approval for the company’s HeartStart FR3 and HeartStart FRx automated external defibrillators. The HeartStart FR3 is a professional-grade AED. It includes advanced features for medical personnel and first-responders who need to treat a cardiac arrest. The HeartStart FRx is a public-access AED. It features what Philips […]
FDA approves Mainstay Medical neurostim device
Mainstay Medical announced that it received FDA premarket approval for its ReActiv8 implantable neurostimulation system for chronic low back pain. ReActiv8 treats intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy and are not candidates for spine surgery, according to a […]
FDA says lay rescuers can use Zoll AED 3 defibrillator
Zoll Medical announced yesterday that its Zoll AED 3 defibrillator received FDA premarket approval (PMA) for use by lay rescuers. Chelmsford, Mass.-based Zoll’s AED 3 defibrillator uses CPR technology with integrated, real-time feedback to deliver guideline-compliant CPR to improve outcomes from sudden cardiac arrest. The company touts its enhanced technology as the first in the […]
FDA approves remote to check out Axonics neuromod device before MRI
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA pre-market approval for its SmartMRI wireless patient remote control. Irvine, Calif.-based Axonics’ wireless control for SmartMRI is used with its implantable r-SNM (sacral neuromodulation) systems that treat urinary and bowel dysfunction. The new control allows for a simplified full-body MRI process by offering a technician a […]
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system
CardioFocus announced today that it received FDA approval for its next-generation HeartLight X3 endoscopic ablation system. Marlborough, Mass.-based CardioFocus’ system treats drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Last year, the company won CE Mark approval in Europe for the device and in February of this year, it announced that it sought out a PMA […]
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