Submissions and Approvals

NeuroLogica’s Mobile Scanner Gets 501(k) Clearance

December 2, 2022

The device can be used at a patient’s bedside as well as in treatment areas including operating rooms. Read More

SeekIn Cancer Recurrence Monitoring Kit Gains CE-IVD Mark

December 1, 2022

The test can be performed within a month of radical surgery, the company said. Read More

SpeedPlate Gets 510(k) Clearance for Bunion and Foot Fracture Repair

December 1, 2022

The company is planning a limited release of SpeedPlate implants with Micro-Lapiplasty instrumentation in the first half of 2023. Read More

Accure Acne’s Laser System Cleared

November 29, 2022

Accure expects to make the Accure laser system available in a limited commercial release to board-certified dermatologists. Read More

SafeSource Direct’s U.S.-Made Chemo-Rated Nitrile Exam Gloves Cleared

November 28, 2022

The company expects to be producing two billion gloves annually by January 2024. Read More

Zimmer Biomet’s Persona OsseoTi Keel Tibia Cleared as Knee Replacement Option

November 23, 2022

The company expects the Persona OsseoTi Keel Tibia to be particularly useful in cases involving arthritis. Read More

H2o Therapeutics’ Parky App for Monitoring Parkinson’s Disease Cleared

November 23, 2022

The app helps clinicians develop a profile of the patient in daily life. Read More

LivaNova’s LifeSPARC Gains 510(k) Clearance for ECMO Use

November 22, 2022

The device first received 510(k) clearance in July 2019 for use in cardiopulmonary bypass. Read More

AEYE Health’s Diagnostic Screening Cleared for Diabetic Retinopathy

November 21, 2022

Diagnostic results are returned in under one minute, according to the company. Read More

FDA Extends Use of Medicine360’s Contraceptive Device

November 18, 2022

The latest approval is based on data from a phase 3 trial in which Liletta was about 99 percent effective in preventing pregnancy up to eight years. Read More

Rockfield Medical Devices Mobility+ Enteral Feeding System Cleared

November 18, 2022

The company plans a limited market release in the coming weeks in the U.S. with a full launch expected in the first quarter of 2023. Read More

FDA Expands 510(k) Clearance of Merit’s Excelsior Software

November 18, 2022

The cloud-based platform transfers files directly from qualified sites to a central database for review. Read More

Submissions and Approvals
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NeuroLogica’s Mobile Scanner Gets 501(k) Clearance

SeekIn Cancer Recurrence Monitoring Kit Gains CE-IVD Mark

SpeedPlate Gets 510(k) Clearance for Bunion and Foot Fracture Repair

Accure Acne’s Laser System Cleared

SafeSource Direct’s U.S.-Made Chemo-Rated Nitrile Exam Gloves Cleared

Zimmer Biomet’s Persona OsseoTi Keel Tibia Cleared as Knee Replacement Option

H2o Therapeutics’ Parky App for Monitoring Parkinson’s Disease Cleared

LivaNova’s LifeSPARC Gains 510(k) Clearance for ECMO Use

AEYE Health’s Diagnostic Screening Cleared for Diabetic Retinopathy

FDA Extends Use of Medicine360’s Contraceptive Device

Rockfield Medical Devices Mobility+ Enteral Feeding System Cleared

FDA Expands 510(k) Clearance of Merit’s Excelsior Software

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The Revised ICH E8: A Guide to New Clinical Trial Requirements

Submissions and Approvals
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