FDA Cleared Archives - Page 8 of 10 - TMG Pulse

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FDA Cleared Orthopedic Spine

Meditech Spine receives FDA clearance for CURE Opel lumbar plate system

Meditech Spine has received US Food and Drug Administration (FDA) 510(k) clearance to market the […]

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FDA Cleared MedTech Women's Health

Gynesonics lands FDA clearance for fibroid-removal system

Gynesonics announced that it received FDA 510(k) clearance for its next-generation Sonata System 2.1 for transcervical […]

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FDA Cleared Orthopedic Spine

Nexxt Spine receives US FDA 510(k) clearance for ALIF and lateral systems

Nexxt Spine has announced US Food and Drug Administration (FDA) 510(k) clearance of two lumbar […]

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FDA Cleared Imaging Radiology

FDA clears United Imaging’s MRI

Medical imaging and radiotherapy outfit United Imaging announced today that it received FDA clearance for its UMR […]

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Digital Health FDA Cleared Respiratory

FDA clears Propeller Health sensor for use with AstraZeneca's Symbicort inhaler

Digital respiratory health company Propeller Health has received 510(k) clearance for a sensor and app […]

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FDA Cleared Respiratory Wearables

Philips receives FDA clearance for patch that monitors breathing

Designed long before the Covid-19 pandemic, Philips received FDA clearance for a wearable sensor that […]

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Diagnostics FDA Cleared Respiratory

4DMedical's Lung Imaging Technology Receives FDA Clearance as COVID-19 Intensifies Global Focus on Respiratory Health

WOODLAND HILLS, Calif., May 25, 2020 /PRNewswire/ — 4DMedical, an Australian medical technology company specializing in medical imaging […]

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Cardiology Diagnostics FDA Cleared

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications

The FDA has granted Philips 510(k) clearance for its ultrasound systems to be used to […]

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FDA Cleared Orthopedic Spine

US FDA approval granted for two Camber Spine devices

Camber Spine has announced US Food and Drug Administration (FDA) clearance and the nationwide launch […]

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FDA Cleared Orthopedic Spine

NuVasive expands Advanced Materials Science implant portfolio

NuVasive has announced the expansion of its Advanced Materials Science (AMS) implant portfolio with the […]

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FDA Cleared MedTech

MOLEKULE Unveils Air Pro Rx Medical Air Filter to Protect Hospitals During COVID Pandemic

Molekule, a company based in San Francisco, is releasing its brand new Air Pro Rx […]

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FDA Cleared MedTech Vascular

Cagent Vascular wins FDA clearance for balloon catheter

Cagent Vascular announced that it received FDA 510(k) clearance for its Serranator percutaneous transluminal angioplasty (PTA) […]

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FDA Cleared Healthcare Imaging

FDA moves to boost access to imaging systems during pandemic

Dive Brief: FDA has cleared medtech companies and healthcare providers to make limited modifications to […]

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FDA Cleared Orthopedic Spine

US FDA clearance for Atlas Spine’s HiJAK SA system

Atlas Spine has announced US Food and Drug Administration (FDA) clearance for the HiJAK SA […]

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FDA Cleared Orthopedic Spine

Life Spine announces FDA 510(k) clearance of the PROLIFT Lateral Fixated system

Life Spine has announced that it has received clearance from the US Food and Drug […]

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FDA Cleared Orthopedic Spine

Astura Medical receives FDA 510(k) clearance for SIRION LLIF system

Astura Medical has announced that it has received 510(k) clearance from the US Food and […]

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FDA Cleared Imaging Spine

Spinal ultrasound imaging platform receives US FDA clearance

Tissue Differentiation Intelligence (TDi) has announced that it has received US Food and Drug Administration […]

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FDA Cleared MedTech

Tablo Hemodialysis System Receives FDA Clearance for Home Use

Outset Medical announced that it received FDA 510(k) clearance for its Tablo Hemodialysis System to […]

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FDA Cleared Wearables Women's Health

INVU Receives FDA Clearance for Remote Pregnancy Monitoring System

Nuvo Group announced that it has received 510(k) clearance from the FDA to market INVU, […]

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FDA Cleared Orthopedic Spine

OrthoPediatrics gains expanded approval for Response scoliosis system

OrthoPediatrics has received 510(k) clearance from the US Food and Drug Administration (FDA) to expand […]

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Digital Health FDA Cleared

In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia

Dive Brief: Pear Therapeutics’ app-based treatment for chronic insomnia has received FDA clearance, the digital […]

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FDA Cleared Implantables Spine

AgNovos receives Breakthrough Device Designation for spine device

AgNovos Healthcare has announced that its newest investigational product, AGN1 Local Osteo-enhancement Procedure (LOEP) Small […]

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FDA Cleared Robotics Surgery

TransEnterix Receives FDA Clearance for Intelligent Surgical Unit

TransEnterix announced that it received FDA 510(k) clearance for its Intelligent Surgical Unit (ISU), a […]

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FDA Cleared Imaging Radiology

RefleXion X1 Cleared to Deliver Radiotherapy and Radiosurgery in U.S.

RefleXion Medical, a company based outside of Oakland, California, won FDA clearance for its RefleXion […]

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FDA Cleared Orthopedic

CoNextions wins FDA 510(k) nod for tenodesis product

CoNextions announced that it won FDA 510(k) clearance for its Coronet system for the fixation of […]

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FDA Cleared Imaging Respiratory

FDA clears Fluidda's digital lung imaging platform for respiratory disease monitoring

The FDA cleared a new digital imaging platform designed to give doctors a clear peek […]

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FDA Cleared Robotics Surgery

TransEnterix nets FDA clearance for AI vision-guided surgery

TransEnterix received an FDA clearance for its “digital surgical assistant,” which it describes as the […]

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FDA Cleared Neuro Wearables

zEEG, An Easy-to-Wear EEG Headset

The electroencephalogram (EEG) is used to detect electrical activity in the brain in order to […]

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FDA Cleared Imaging

Kinepict Health wins FDA nod for imaging tech

Kinepict Health announced today that it won FDA 510(k) clearance for its Kinepict Medical Imaging Tool […]

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FDA Cleared Orthopedic Spine

Study supports use of Attrax Putty as substitute for autograft

NuVasive has announced the results of a study supporting the use of Attrax Putty as […]

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ENT FDA Cleared

Aerin Medical Gets FDA Clearance for Nonsurgical Chronic Rhinitis Procedure

Aerin Medical, based in Austin, Texas, announced this week FDA clearance and US launch of […]

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CE Mark FDA Cleared Imaging

Mauna Kea lands 510(k), CE Mark for next-gen Cellvizio platform

Mauna Kea (ENT:MKEA) this week said it won FDA clearance and CE Mark approval for its […]

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FDA Cleared Spine

FDA clearance for use of Agilon bone graft in spine procedures

Biogennix has received US Food and Drug Administration (FDA) 510(k) clearance for an expanded indication […]

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FDA Cleared Spine

Life Spine receives additional US FDA clearance for the PROLIFT expandable system

Life Spine has received an additional clearance from the US Food and Drug Administration (FDA) […]

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FDA Cleared Pediatrics Respiratory

Masimo gains FDA clearance for new respiration rate measurement system

Masimo (NSDQ:MASI) said today that the FDA has granted 510(k) clearance to its continuous RRp (respiration […]

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Cardiology FDA Cleared

CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication

CHF Solutions (NSDQ:CHFS) announced today that it received FDA 510(k) clearance for its next-generation Aquadex SmartFlow […]

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Cardiology FDA Cleared Surgery

LivaNova gets nod for heater-cooler device changes to cut contamination risk

Dive Brief: LivaNova has received 510(k) clearance for a modification to its Heater-Cooler System 3T […]

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Cardiology FDA Cleared Structural Heart

Analysis casts doubt on Boston Scientific TAVR embolic protection device

Dive Brief: A research letter and editorial published online Monday in JAMA Internal Medicine renews […]

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Cardiology FDA Cleared Surgery

Abbott’s Gallant Cardiac Implants Cleared in Europe

Abbott won clearance in the European Union for its new Gallant implantable cardioverter defibrillator (ICD) […]

Topic: FDA Cleared

Meditech Spine receives FDA clearance for CURE Opel lumbar plate system

Gynesonics lands FDA clearance for fibroid-removal system

Nexxt Spine receives US FDA 510(k) clearance for ALIF and lateral systems

FDA clears United Imaging’s MRI

FDA clears Propeller Health sensor for use with AstraZeneca's Symbicort inhaler

Philips receives FDA clearance for patch that monitors breathing

4DMedical's Lung Imaging Technology Receives FDA Clearance as COVID-19 Intensifies Global Focus on Respiratory Health

Philips Ultrasounds Cleared in U.S. to Manage COVID Complications

US FDA approval granted for two Camber Spine devices

NuVasive expands Advanced Materials Science implant portfolio

MOLEKULE Unveils Air Pro Rx Medical Air Filter to Protect Hospitals During COVID Pandemic

Cagent Vascular wins FDA clearance for balloon catheter

FDA moves to boost access to imaging systems during pandemic

US FDA clearance for Atlas Spine’s HiJAK SA system

Life Spine announces FDA 510(k) clearance of the PROLIFT Lateral Fixated system

Astura Medical receives FDA 510(k) clearance for SIRION LLIF system

Spinal ultrasound imaging platform receives US FDA clearance

Tablo Hemodialysis System Receives FDA Clearance for Home Use

INVU Receives FDA Clearance for Remote Pregnancy Monitoring System

OrthoPediatrics gains expanded approval for Response scoliosis system

In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia

AgNovos receives Breakthrough Device Designation for spine device

TransEnterix Receives FDA Clearance for Intelligent Surgical Unit

RefleXion X1 Cleared to Deliver Radiotherapy and Radiosurgery in U.S.

CoNextions wins FDA 510(k) nod for tenodesis product

FDA clears Fluidda's digital lung imaging platform for respiratory disease monitoring

TransEnterix nets FDA clearance for AI vision-guided surgery

zEEG, An Easy-to-Wear EEG Headset

Kinepict Health wins FDA nod for imaging tech

Study supports use of Attrax Putty as substitute for autograft

Aerin Medical Gets FDA Clearance for Nonsurgical Chronic Rhinitis Procedure

Mauna Kea lands 510(k), CE Mark for next-gen Cellvizio platform

FDA clearance for use of Agilon bone graft in spine procedures

Life Spine receives additional US FDA clearance for the PROLIFT expandable system

Masimo gains FDA clearance for new respiration rate measurement system

CHF Solutions wins FDA nod for Aquadex SmartFlow pediatric indication

LivaNova gets nod for heater-cooler device changes to cut contamination risk

Analysis casts doubt on Boston Scientific TAVR embolic protection device

Abbott’s Gallant Cardiac Implants Cleared in Europe