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 […]
FDA: Coronavirus may extend medtech application reviews
The FDA may not be able to meet its deadlines for reviewing medical device applications due to constraints posed by the coronavirus pandemic, Commissioner Stephen Hahn announced yesterday. The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are still on track to meet the goals set in […]
Axonics wins FDA approval for next-gen neurostimulator
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA approval for its next-generation rechargeable neurostimulator for its r-SNM system. The Irvine, Calif.-based company’s r-SNM system is an implantable sacral neuromodulation (SNM) device for treating urinary and bowel dysfunction. Its most recent regulatory win came in January when the FDA approved a second-generation programmer for the […]
FDA asks manufacturers to help prevent protective gear shortages
The FDA said today it wants to hear from surgical mask and gown manufacturers that might be able to increase or speed production to prevent shortages in the U.S. during the COVID-19 outbreak. The agency said it may expedite review of manufacturing site changes or premarket submissions of personal protective equipment, including protective clothing, gowns, […]
CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in […]
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