Category:
FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
Avinger Announces FDA Clearance of Pantheris for the Treatment of In-Stent Restenosis
"We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options," commented Jeff Soinski, Avinger's President and CEO.
Advantis Medical Imaging Receives FDA Clearance for Brain MRI Analysis Software
Advantis Medical Imaging notes with this first FDA clearance the company aims to collaborate with U.S. clinicians by assisting them to focus on clinical findings and save valuable time.
Philips Advances Ultrasound Portfolio with New Robust Imaging Tools & Features for Radiology to Increase Diagnostic Confidence and Workflow Efficiency
Philips will debut its Liver Fat Quantification solution at the Radiological Society of North America (RSNA) Annual Meeting later this month.
GE Healthcare Receives FDA Clearance for First X-ray AI to Help Assess Endotracheal Tube Placement
The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.
Medtronic Reports 510(k) Clearance for PillCam™ Small Bowel 3 @HOME Endoscopy Procedure
PillCam SB3 @HOME provides a telehealth option for direct visualization and monitoring of the small bowel, to help better detect lesions not detected by upper and lower endoscopy that may: 1) indicate Crohn's disease, 2) locate obscure bleeding, or 3) identify sources of iron deficiency anemia (IDA).
HeartVista Receives FDA 510(k) Clearance to Deliver One Click MRI™ on Siemens Healthineers MRI Scanners
HeartVista, a pioneer in AI-assisted MRI solutions, today announced it has received 510(k) Clearance from the U.S. Food and Drug Administration, to deliver its...
VUNO Med®-DeepECG™ Designated as Breakthrough Device
VUNO Chairman Lee Yeha said, "VUNO will continue to deliver the value of AI to even more beneficiaries through a wide range of biosignal initiatives, including the use of ECG data with its significant potential for providing clues to serious heart-related diseases."
Magnus Medical Launches With Breakthrough Device Designation for Rapid, Individualized Treatment of Major Depression and $25M in Series A Financing
The Magnus System is based on the SAINT technology, which was licensed exclusively to Magnus Medical from Stanford University for commercialization.
Samsung Receives FDA Clearance for AI Algorithms that Detect Lung Nodules in Chest X-rays
“This FDA clearance is a huge milestone for Samsung and is the result of our tireless work to design diagnostic solutions that empower providers to deliver patients the absolute best care possible,” said David Legg, Vice President of Digital Radiography and Ultrasound at Samsung NeuroLogica.
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