FDA Cleared Archives - Page 9 of 10 - TMG Pulse

Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment

Critically ill patients with acute respiratory or cardiopulmonary failure who are on long-term mechanical ventilation […]

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Drug-delivery FDA Cleared Vascular

United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin®

Remunity™ expected to be available for patients by July 2020 RESEARCH TRIANGLE PARK, N.C. and MANCHESTER, N.H., Feb. […]

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FDA Cleared Vascular

Surfacer FDA Cleared for Unusual Dialysis Central Venous Access

The right internal jugular vein is typically the ideal access point for performing hemodialysis via […]

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Cardiology CE Mark FDA Cleared Imaging

Acutus Medical Secures FDA Clearance, CE Mark for SuperMap™ and Announces First Procedures in U.S. and Initial Experience in EU

Breakthrough Technology Enables Super-Fast Electrical Mapping and Re-Mapping of the Entire Heart Chamber – Leading […]

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FDA Cleared Neuro Radiology

World’s First Portable MRI Cleared by FDA

Magnetic resonance imaging (MRI) has revolutionized medicine, but MRI scanners are so demanding that access […]

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AI FDA Cleared Oncology Radiology

Ethos AI-Powered Radiotherapy System Follows Movement of Tumors

Varian has won FDA clearance for its Ethos therapy technology, which the company describes as […]

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FDA Cleared Orthopedic Spine

Medicrea wins FDA clearance for patient-matched spinal interbody cages

Medicrea (EPA:ALMED) announced today that it won FDA clearance for its UNiD IB3D patient-matched interbody cages […]

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Digital Health FDA Cleared Patient Monitoring

BioIntelliSense wins FDA nod for BioSticker continuous vital sign monitor

BioIntelliSense announced that it won FDA 510(k) clearance for its BioSticker on-body sensor for scalable remote […]

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FDA Cleared Neuro Vascular

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

Rist Neurovascular recently announced that it has received US Food and Drug Administration (FDA) 510(k) […]

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FDA Cleared Implantables Spine

US FDA approval for Medicrea’s patient-matched interbody cages

Medicrea has received US Food and Drug Administration (FDA) clearance for UNiD IB3D patient-matched interbody […]

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AI Diagnostics FDA Cleared

AI-assisted cardiac ultrasound guidance software receives De Novo clearance

The first artificial intelligence-enabled cardiac ultrasound software has received De Novo marketing authorization, the FDA […]

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FDA Cleared Sensors Wearables

BioSticker FDA Cleared for Month-Long Vitals Monitoring

BioIntelliSense, a Silicon Valley firm, won FDA clearance for its BioSticker wearable sensor and the […]

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FDA Cleared Spine

Life Spine receives US FDA 510(k) clearance for Steerable Plateau Ti system

Life Spine has announced that it has received 510(k) clearance from the US Food & […]

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FDA Cleared Implantables Orthopedic

In2Bones wins FDA clearance for Quantum total ankle

In2Bones announced today that it won FDA 510(k) clearance for its Quantum Total Ankle system to […]

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Digital Health FDA Cleared Imaging

FDA clears Sony's surgery video-sharing platform

Multinational conglomerate Sony has received a clearance from the FDA for its digital workflow collaboration […]

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FDA Cleared Imaging

FDA clears Olympus duodenoscope with disposable endcap

Olympus (TYO:7733) announced that it won FDA clearance for its TJF-Q190V duodenoscope with a sterile, disposable […]

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Digital Health FDA Cleared

Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope

Duodenoscope with Sterile, Disposable Endcap Improves Ease of Reprocessing while Offering Advanced Features for Improved […]

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AI Digital Health FDA Cleared

Eko wins FDA clearance for heart murmur, Afib algorithm

Eko Devices has secured FDA clearance for an algorithm that allows its digital stethoscopes to […]

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FDA Cleared Patient Monitoring Sensors

FDA clears smart inhaler cap from Cognita Labs

Santa Ana, California-based startup Cognita Labs has won FDA clearance for its first device, a […]

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FDA Cleared Sensors Wearables

FDA Clears VivaLNK's Wearable ECG Platform

FDA has cleared VivaLNK’s continuous ECG platform. Consisting of reusable wearable ECG sensors and associated software […]

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Cardiology FDA Cleared

BioCardia Fills in a Key Piece of CardiaAmp Puzzle with New Clearance

BioCardia has filled in another piece of the CardiAmp Cell Therapy puzzle with a new […]

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FDA Cleared Gastroenterology Imaging

PENTAX Releases IMAGINA LED Powered Endoscopy System

PENTAX is releasing its IMAGINA Endoscopy System in the U.S., having just received FDA clearance […]

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AI FDA Cleared Neuro

US FDA clears Aidoc’s complete AI stroke package

Aidoc has announced that the US Food and Drug Administration (FDA) has cleared its AI […]

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FDA Cleared Neuro Vascular

Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism

ALAMEDA, Calif.–(BUSINESS WIRE)– Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today […]

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FDA Cleared Wearables

Reliefband unveils therapeutic wearables and gets expanded FDA approval for treating motion sickness

Reliefband Technologies has unveiled a new line of therapeutic wearables that prevent nausea and vomiting […]

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FDA Cleared Surgery

Augmedics Secures FDA Clearance for xvision, an AR Surgical Guidance System

Augmedics, a Chicago-based startup developing surgical virtual reality technologies, received FDA 510k clearance for its […]

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Cardiology FDA Cleared Ophthalmology

Masimo’s RD SET Sensors Now with Improved Accuracy for Neonates

Masimo has won FDA clearance for its RD SET sensors, that feature the company’s signature […]

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Diagnostics FDA Cleared

Masimo’s improved pulse oximetry tech now available to all U.S. newborns

Masimo (NSDQ:MASI) has won FDA clearance for pulse oximetry sensors with improved oxygen saturation accuracy specifications […]

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FDA Cleared Spine Surgery

Augmedics launches its Xvision Spine AR nav system in U.S.

Augmedics announced today that it won FDA 510(k) clearance for and initiated the U.S. launch of […]

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Digital Health FDA Cleared

Osia, a New Type of Implantable Hearing Solution by Cochlear, Secures FDA Clearance: Interview

Earlier this month, Cochlear received FDA clearance for the Osia 2 System, the first active […]

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FDA Cleared Surgery

PENTAX Releases EB19-J10U Ultrasound Video Bronchoscope in U.S.

PENTAX has announced that its new EB19-J10U endobronchial scope, having received FDA clearance, is coming […]

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FDA Cleared Gastroenterology

Interscope wins FDA clearance for EndoRotor System

Interscope this week said it won FDA clearance for its EndoRotor System. The system is […]

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Biotech FDA Cleared

TAP At-Home Blood Collection System Now FDA Cleared

Seventh Sense Biosystems, a company based outside of Boston, MA, won FDA clearance for its […]

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FDA Cleared Neuro Robotics

Medtronic Stealth Autoguide System for Cranial Procedures FDA Cleared

The Stealth Autoguide, a cranial robotic platform from Medtronic, has just been cleared by the […]

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Digital Health FDA Cleared Imaging

FDA clears etectRx ingestible event marker

EtectRx this week announced that the FDA cleared its ID-Cap System ingestible event marker. The ID-Cap […]

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Drug-delivery FDA Cleared

Interoperable automated glycemic controller receives De Novo clearance

The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device […]

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FDA Cleared Gastroenterology

Boston Scientific Wins FDA Clearance for the World's First Fully Disposable Duodenoscope

Contamination on duodenoscopes after reprocessing continues to be a major concern in the United States, but […]

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FDA Cleared Imaging

Siemens Healthineers lands FDA clearance for two CT systems

Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom […]

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FDA Cleared MedTech

ImpediMed lands expanded 510(k) clearance for Sozo

ImpediMed this week said it received expanded FDA 510(k) clearance for its Sozo bioimpedance spectroscopy […]

Topic: FDA Cleared

Novalung FDA Cleared to Provide Long-Term Lung Failure Treatment

United Therapeutics and DEKA Announce Additional FDA Clearance Related to the Unity Subcutaneous Delivery System for Remodulin®

Surfacer FDA Cleared for Unusual Dialysis Central Venous Access

Acutus Medical Secures FDA Clearance, CE Mark for SuperMap™ and Announces First Procedures in U.S. and Initial Experience in EU

World’s First Portable MRI Cleared by FDA

Ethos AI-Powered Radiotherapy System Follows Movement of Tumors

Medicrea wins FDA clearance for patient-matched spinal interbody cages

BioIntelliSense wins FDA nod for BioSticker continuous vital sign monitor

Rist Neurovascular radial artery catheter receives FDA 510(k) clearance

US FDA approval for Medicrea’s patient-matched interbody cages

AI-assisted cardiac ultrasound guidance software receives De Novo clearance

BioSticker FDA Cleared for Month-Long Vitals Monitoring

Life Spine receives US FDA 510(k) clearance for Steerable Plateau Ti system

In2Bones wins FDA clearance for Quantum total ankle

FDA clears Sony's surgery video-sharing platform

FDA clears Olympus duodenoscope with disposable endcap

Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope

Eko wins FDA clearance for heart murmur, Afib algorithm

FDA clears smart inhaler cap from Cognita Labs

FDA Clears VivaLNK's Wearable ECG Platform

BioCardia Fills in a Key Piece of CardiaAmp Puzzle with New Clearance

PENTAX Releases IMAGINA LED Powered Endoscopy System

US FDA clears Aidoc’s complete AI stroke package

Penumbra Announces FDA Clearance of Indigo® Aspiration System for Treatment of Pulmonary Embolism

Reliefband unveils therapeutic wearables and gets expanded FDA approval for treating motion sickness

Augmedics Secures FDA Clearance for xvision, an AR Surgical Guidance System

Masimo’s RD SET Sensors Now with Improved Accuracy for Neonates

Masimo’s improved pulse oximetry tech now available to all U.S. newborns

Augmedics launches its Xvision Spine AR nav system in U.S.

Osia, a New Type of Implantable Hearing Solution by Cochlear, Secures FDA Clearance: Interview

PENTAX Releases EB19-J10U Ultrasound Video Bronchoscope in U.S.

Interscope wins FDA clearance for EndoRotor System

TAP At-Home Blood Collection System Now FDA Cleared

Medtronic Stealth Autoguide System for Cranial Procedures FDA Cleared

FDA clears etectRx ingestible event marker

Interoperable automated glycemic controller receives De Novo clearance

Boston Scientific Wins FDA Clearance for the World's First Fully Disposable Duodenoscope

Siemens Healthineers lands FDA clearance for two CT systems

ImpediMed lands expanded 510(k) clearance for Sozo