FDA Cleared Archives - Page 7 of 10 - TMG Pulse

FDA clears LifeSpine anterior lumbar spacer system

Spinal disorder treatment developer Life Spine announced that it received FDA clearance for its Plateau-A Ti anterior […]

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Digital Health FDA Cleared Wearables

Samsung says it has received FDA clearance for smartwatch ECG tracking

Alongside yesterday’s reveal of the Galaxy Watch3, Samsung announced that it has received regulatory clearance […]

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FDA Cleared Imaging Radiology

FDA clears SOMATOM On.site from Siemens Healthineers for CT exams at the bedside

The US Food and Drug Administration (FDA) has cleared the SOMATOM On.site, a mobile head […]

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FDA Cleared Robotics Surgery

Yomi robotic system from Neocis gets FDA approval for full-arch dental implants

Neocis Inc. today said that it has received 510(k) clearance from the U.S. Food and […]

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AI FDA Cleared Radiology

Zebra Medical Vision receives 510(k) clearance for AI mammogram tool

Zebra Medical Vision has announced its latest Food and Drug Administration 510(k) clearance for HealthMammo, […]

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AI FDA Cleared Imaging

FDA clears Canon Medical AI-based image reconstruction tech

Canon Medical (NYSE:CAJ) announced today that it received FDA 510(k) clearance for its advanced intelligent clear-IQ […]

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FDA Cleared Patient Monitoring Wearables

LifeSignals wireless biosensor wins FDA clearance

LifeSignals Group announced today that it received FDA 510(k) clearance for its LifeSignals ECG remote monitoring […]

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FDA Cleared Implantables Orthopedic

FX Shoulder gets FDA nod for coated shoulder implants

FX Shoulder USA announced today that the FDA issued 510(k) clearance for a new version […]

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FDA Cleared Imaging MedTech

Micro-X mobile X-ray system FDA cleared

Micro-X announced today that its Rover mobile X-ray product designed for military medical facilities received FDA […]

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FDA Cleared Patient Monitoring Wearables

Vitls Platform Cleared in U.S. for Remote Patient Monitoring

Vitls Inc., a company out of Houston, Texas, won FDA clearance for its Vitls Platform, […]

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FDA Cleared Patient Monitoring Wearables

Vitls scores 510(k) clearance for continual and remote vital signs monitoring device

Today the remote and continuous monitoring platform Vitls announced that it has received 510(k) clearance […]

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FDA Cleared Radiology Robotics

XACT ACE™ Robotic System Cleared by FDA for Image-Guided Percutaneous Procedures

– Hands-free robotic system combines image-based planning and navigation with instrument insertion and steering delivering procedural […]

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AI FDA Cleared Neuro

Avicenna.AI secures FDA clearance for its CINA Head neurovascular imaging artificial intelligence tool

Medical imaging artificial intelligence (AI) specialist Avicenna.AI has announced it has received 510(k) clearance from […]

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Cardiology FDA Cleared Pediatrics

Getinge Servo-air Multi-Purpose Mechanical Ventilator FDA Cleared

Getinge has won FDA clearance for its Servo-air mechanical ventilator. The device doesn’t need any […]

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FDA Cleared Imaging Respiratory

Infervision’s lung CT.AI systems clears FDA

Infervision announced that it received FDA 501(k) clearance for its InferRead Lung CT.AI system which uses […]

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Drug-delivery FDA Cleared Patient Monitoring

iVWatch lands FDA clearance for continuous intravenous monitoring device

Continuous IV monitoring system developer ivWatch announced that it received FDA clearance for its new SmartTouch disposable […]

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Diagnostics Digital Health FDA Cleared

FDA clears Nonin Medical flagship product

Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product […]

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Cardiology CE Mark FDA Cleared

Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

Dive Brief: Medtronic on Tuesday said it received FDA 510(k) clearance and CE marking for […]

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FDA Cleared Imaging Neuro

RapidAI snags FDA clearance for neuroimaging analysis device

RapidAI, a health tech company specializing in stroke imaging, has received clearance from the FDA […]

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FDA Cleared MedTech Orthopedic

IluminOss lands expanded FDA clearance for fracture repair tech

IlluminOss Medical recently announced that it received FDA 510(k) clearance for expanded use of its […]

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FDA Cleared Spine Surgery

Spinal Elements receives US FDA approval for Sapphire X device

Spinal Elements has announced US Food and Drug Administration (FDA) clearance of the Sapphire X […]

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FDA Cleared Spine Surgery

FDA Clears Spinal Elements’s Anterior Cervical Fixation System

Spinal Elements has obtained a nod from FDA for its Sapphire X for anterior cervical […]

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FDA Cleared Spine Surgery

Spinal Elements’ cervical fixation system wins FDA nod

Spine surgery technology developer Spinal Elements announced today that it received FDA clearance for its […]

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AI FDA Cleared Start-Up

Qure.ai gets FDA clearance for its head CT scan product qER

Mumbai-based healthcare AI startup Qure.ai earlier this week announced its first US FDA 510(k) clearance […]

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Cardiology FDA Cleared Implantables

Boston Sci’s Lux-Dx Smart Implantable Arrhythmia Detector FDA Cleared

Boston Scientific has announced winning FDA clearance for its LUX-Dx Insertable Cardiac Monitor (ICM), an […]

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FDA Cleared Orthopedic Spine

CoreLink launches F3D-C2 standalone cervical system

CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug […]

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Diagnostics FDA Cleared Radiology

Qure.ai Secures FDA Clearance for Head CT Scan Technology

Qure.ai said it has received FDA clearance for its first head CT scan product. The […]

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FDA Cleared Orthopedic Spine

CoreLink wins FDA clearance for standalone cervical spine system

CoreLink announced today that it received FDA 510(k) clearance for its F3D-C2 standalone cervical system for […]

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FDA Cleared Orthopedic Spine

FDA clears Orthofix Firebird SI fusion system

Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium […]

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FDA Cleared MedTech Respiratory

Circadia Health's contactless respiration rate monitor receives 510(k) clearance

London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for […]

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ENT FDA Cleared Pediatrics

FDA clears Preceptis Medical’s in-office ear tube placement for kids

Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in […]

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ENT FDA Cleared MedTech

Colibri Micro Single-Use ENT Endoscope Coming to U.S.

3NT Medical, a company based in Israel, has won FDA clearance to introduce its Colibri […]

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FDA Cleared Patient Monitoring Wearables

Abbott’s Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared

After a long wait, the FDA has finally cleared Abbott’s FreeStyle Libre 2 continuous glucose […]

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FDA Cleared Orthopedic Spine

Sirakoss receives US FDA clearance for Osteo3 ZP Putty

Sirakoss, a developer of nanosynthetic bone graft substitutes, announced today that it has received 510(k) […]

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FDA Cleared Imaging MedTech

Canon wins FDA clearance for speedy MRI

Canon (NYSE:CAJ) announced that it received FDA clearance for its compressed Speeder technology to speed up […]

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Drug-delivery FDA Cleared MedTech

Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

Dive Brief: Abbott has received FDA clearance for the latest version of its blockbuster FreeStyle […]

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FDA Cleared Orthopedic Spine

MiRus announces first clinical use of the 3DR printed lumbar interbody fusion system

MiRus has announced that it received US Food and Drug Administration (FDA) 510(k) clearance for […]

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FDA Cleared Implantables Spine

FDA clearance for 4WEB’s ASTS-SA lumbar interbody fusion device

4WEB Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) to […]

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Digital Health FDA Cleared Patient Monitoring

BlueStar's eighth FDA clearance adds long-acting basal insulin support for Type 2 patients

WellDoc’s BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow […]

Topic: FDA Cleared

FDA clears LifeSpine anterior lumbar spacer system

Samsung says it has received FDA clearance for smartwatch ECG tracking

FDA clears SOMATOM On.site from Siemens Healthineers for CT exams at the bedside

Yomi robotic system from Neocis gets FDA approval for full-arch dental implants

Zebra Medical Vision receives 510(k) clearance for AI mammogram tool

FDA clears Canon Medical AI-based image reconstruction tech

LifeSignals wireless biosensor wins FDA clearance

FX Shoulder gets FDA nod for coated shoulder implants

Micro-X mobile X-ray system FDA cleared

Vitls Platform Cleared in U.S. for Remote Patient Monitoring

Vitls scores 510(k) clearance for continual and remote vital signs monitoring device

XACT ACE™ Robotic System Cleared by FDA for Image-Guided Percutaneous Procedures

Avicenna.AI secures FDA clearance for its CINA Head neurovascular imaging artificial intelligence tool

Getinge Servo-air Multi-Purpose Mechanical Ventilator FDA Cleared

Infervision’s lung CT.AI systems clears FDA

iVWatch lands FDA clearance for continuous intravenous monitoring device

FDA clears Nonin Medical flagship product

Newest Medtronic implantable heart monitor gets FDA nod as remote device features proliferate

RapidAI snags FDA clearance for neuroimaging analysis device

IluminOss lands expanded FDA clearance for fracture repair tech

Spinal Elements receives US FDA approval for Sapphire X device

FDA Clears Spinal Elements’s Anterior Cervical Fixation System

Spinal Elements’ cervical fixation system wins FDA nod

Qure.ai gets FDA clearance for its head CT scan product qER

Boston Sci’s Lux-Dx Smart Implantable Arrhythmia Detector FDA Cleared

CoreLink launches F3D-C2 standalone cervical system

Qure.ai Secures FDA Clearance for Head CT Scan Technology

CoreLink wins FDA clearance for standalone cervical spine system

FDA clears Orthofix Firebird SI fusion system

Circadia Health's contactless respiration rate monitor receives 510(k) clearance

FDA clears Preceptis Medical’s in-office ear tube placement for kids

Colibri Micro Single-Use ENT Endoscope Coming to U.S.

Abbott’s Freestyle Libre 2 Advanced Wearable Glucometer FDA Cleared

Sirakoss receives US FDA clearance for Osteo3 ZP Putty

Canon wins FDA clearance for speedy MRI

Abbott's FreeStyle Libre 2 gets long-awaited iCGM nod from FDA

MiRus announces first clinical use of the 3DR printed lumbar interbody fusion system

FDA clearance for 4WEB’s ASTS-SA lumbar interbody fusion device

BlueStar's eighth FDA clearance adds long-acting basal insulin support for Type 2 patients