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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.
MedAlliance SELUTION SLR Receives Second FDA IDE Approval
Enrollment will begin in the SELUTION SLR IDE SFA study later this year. It will be conducted at over 20 centers in the US and an additional 20 centers around the world advises MedAlliamce.
Movano Ring Exceeds Accuracy Targets for SpO2 and Heart Rate Monitoring in Initial Hypoxia Study; Company Eyes FDA Submission
Vital health metric demonstrates wearable’s potential to properly track heart health and detect possible illnesses reports Movano.
NeuroOne Submits Special 510(k) to FDA for Evo® sEEG Electrode
Dave Rosa, Chief Executive Officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline. We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion."
MicroPort Navibot Receives 510(K) Clearance for SkyWalker™, the Company’s First Robot-Assisted Platform for Orthopedic ApplicationsI
The SkyWalker Total Knee System is the first robot-assisted platform from MicroPort and will initially offer a robotically assisted total knee replacement solution compatible with its Evolution Medial-Pivot knee system
Pulse Biosciences Receives FDA 510(k) Clearance of Expanded Energy Settings for use with the CellFX® System
A company spokesperson said, "We are pleased with how quickly the FDA cleared these new energy settings based on the data we provided, requiring 53 of the allotted 90-day review period, to determine that the expanded settings are safe and effective for use with the CellFX System. We appreciate the ongoing collaboration with FDA as we continue to expand the clinical applications for the CellFX System.”
BIOTRONIK Receives FDA Approval of the Pulsar®-18 T3 Peripheral Self-Expanding Stent System
BIOTRONIK also announced the full U.S. commercial launch of the device, which will begin in early August.
Radialis PET Imager Receives FDA Clearance
The heightened sensitivity of the Radialis PET Imager to radiotracer enables the system to produce functional images with high spatial resolution, expanding the insight available from molecular imaging.
Pulnovo Medical Concludes Successfully First Pre-Sub Meeting with FDA for PADN Global Clinical Trial
Patients enrolled in the PADN-CFDA study experienced significant improvements in all study endpoints, hemodynamic standard and physical functioning capacity with no device related adverse events reports Pulnovo Medical.
Medtronic Receives FDA Clearance for Next-generation UNiD™ Spine Analyzer with Degenerative Spine Surgery Predictive Model
Powered by a database of over 10,000 surgical cases, Medtronic continues to evolve the UNiD™ platform to help surgeons plan procedures, personalize care for their patients and predict post-operative spinal compensation.
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