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Monday, August 15, 2022

MEDICAL DEVICE NEWS MAGAZINE

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FDA

Avenda Health Receives FDA Investigational Device Exemption for AI-enabled Prostate Cancer Therapy

Avenda Health said the IDE will allow these two technologies to be used together in a randomized control trial to show superiority over standard of care for the treatment of prostate cancer.

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.”

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