FDA Cleared Archives - Page 6 of 10 - TMG Pulse

FDA Cleared Patient Monitoring Wearables

Caretaker Medical wearable patient monitor wins Health Canada clearance for COVID-19

Caretaker Medical announced that it received Health Canada emergency authorization for its Caretaker wearable patient monitor. […]

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FDA Cleared Respiratory Start-Up

Respiratory Health company AireHealth lands 510(k) for connected nebulizer

AireHealth, a Floridian startup focused on the respiratory health space, landed an FDA 501(k) clearance […]

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Cardiology FDA Cleared Patient Monitoring

Alivecor wins FDA clearance for next-gen interpretive ECG algorithms

AI-based electrocardiogram (ECG) technology developer AliveCor announced that it received FDA clearance for its next-gen ECG algorithms. […]

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FDA Cleared Robotics Surgery

FDA clears Think Surgical’s second-gen robotic knee surgery system

Think Surgical announced today that FDA has granted 510(k) clearance for the second generation of its […]

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ENT FDA Cleared MedTech

OtoSet Automatic Ear Cleaning Device FDA Cleared

SafKan Health, a firm based in Tucson, Arizona, won FDA clearance and is about to […]

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FDA Cleared MedTech Surgery

Allotrope Medical Announces FDA Clearance of StimSite™

HOUSTON, Nov. 17, 2020 /PRNewswire/ — Allotrope Medical™ Inc., a company committed to advancing surgical safety and precision, […]

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Diagnostics FDA Cleared Imaging

Lantheus gains FDA clearance for bone scan AI

Lantheus Holdings (NSDQ:LNTH) announced today that it received FDA 510(k) clearance for its automated bone scan […]

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FDA Cleared Imaging Neuro

FDA Clears Most Powerful Clinical MRI

GE Healthcare won FDA clearance for its SIGNA 7.0T MRI scanner, currently the most powerful […]

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Digital Health FDA Cleared Wearables

FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder

NightWare’s digital therapeutic monitors a wearer’s heart rate and movement to detect disturbances during sleep, […]

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FDA Cleared MedTech Neuro

Medtronic wins FDA clearance for nerve monitoring system, acquires Ai Biomed

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its NIM Vital, and it’s […]

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FDA Cleared Implantables Orthopedic

FDA clears Life Spine revision device

Life Spine announced today that it has received FDA clearance to market a sacroiliac (SI) […]

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Digital Health FDA Cleared Radiology

Siemens Ysio Max Digital Radiography System FDA Cleared

Siemens Healthineers won clearance from the FDA for the Ysio Max digital radiography system that […]

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Diagnostics FDA Cleared Imaging

FDA clears AI for Vida Diagnostics lung imaging analysis software

Vida Diagnostics announced that it received FDA 510(k) clearance for enhancements to its AI-based LungPrint solution. […]

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FDA Cleared Orthopedic

FDA clears Tyber Medical foot and ankle plating system

Tyber Medical today said it received FDA clearance for its new line of foot and […]

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AI FDA Cleared Radiology

Aidoc Wins Clearance for AI Solution that Flags Incidental Pulmonary Embolism

Aidoc has been awarded its sixth 510(k) clearance from FDA for an artificial intelligence solution. […]

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FDA Cleared Robotics Surgery Uncategorized

FDA clears Origami Surgical suture-delivery device

Origami Surgical announced that the FDA has cleared StitchKit PARK, a device that enables […]

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AI FDA Cleared Imaging

GE Healthcare Combines Ultrasound and AI for Cardio Exam Solution

GE Healthcare’s latest cleared device from FDA combines artificial intelligence and ultrasound to help in […]

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FDA Cleared Imaging MedTech

Olympus gains 510(k) clearance for colonoscopes

Olympus (TYO:7733) announced that it has received FDA 510(k) clearance for its PCF-H190T and PCF-HQ190 colonoscopes. […]

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FDA Cleared MedTech

BD’s automated flow cytometry system wins FDA clearance

Becton Dickinson (NYSE:BDX) today announced it has received 510(k) clearance from the FDA for its FACSLyric […]

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FDA Cleared Orthopedic Spine

Orthofix FIREBIRD SI fusion system receives additional US FDA clearance for nanotechnology

The US Food and Drug Administration (FDA) has given Orthofix Medical 510(k) clearance for the nanotechnology feature of the Firebird SI fusion system, the 3D-printed […]

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FDA Cleared Orthopedic Spine

SurGenTec wins FDA nod for 3D GraftRasp system

SurGenTec announced today that it received FDA 510(k) clearance for its 3D GraftRasp system for […]

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Cardiology FDA Cleared Pediatrics

FDA Clears Masimo’s Go Anywhere Pulse Oximeter and Respiration Rate Monitor

Masimo won FDA clearance for its Rad-G pulse oximeter, a rugged device developed with the […]

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Diagnostics FDA Cleared

FDA clears Masimo’s Rad-G pulse oximeter

Masimo (NSDQ:MASI) said today that FDA has granted a 510(k) clearance for its rugged handheld Rad-G […]

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FDA Cleared MedTech Vascular

Philips launches thrombectomy system

Royal Philips (NYSE:PHG) announced today that it launched its Quicklear mechanical thrombectomy system in the U.S. […]

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FDA Cleared Orthopedic Surgery

RTI Surgical gains 510(k) clearance for compression plate

RTI Surgical this week announced that it received FDA 510(k) clearance for its Dynamic Active […]

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Diagnostics Digital Health FDA Cleared

Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic

Cognoa is vying for FDA clearance of a digital device that has the potential to […]

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FDA Cleared M&A Surgery

Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty

Dive Brief: Intersect ENT announced Tuesday it struck a deal to buy German electromagnetic surgical […]

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FDA Cleared MedTech Patient Monitoring

FDA clears Capsule Technologies’ addition of Masimo tech to patient monitor

Capsule Technologies has received FDA 510(k) clearance for its Vitals Plus patient monitor with […]

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FDA Cleared Patient Monitoring Respiratory

Capsule Technologies earns FDA green light on capnography monitor

Capsule Technologies, a medical device-maker (not to be confused with digital pharmacy Capsule), has just landed […]

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FDA Cleared Orthopedic

B-Temia wins FDA clearance for mobility exoskeleton

B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system. […]

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FDA Cleared Neuro Surgery

Minnetronix Medical wins FDA clearance for neurosurgical access port

The FDA has cleared Minnetronix Medical‘s MindsEye neurosurgical access port for deep brain surgeries, the company […]

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FDA Cleared MedTech Patient Monitoring

Masimo scores extended FDA clearance for cerebral hemoglobin monitoring

Connected care company Masimo has landed and expanded FDA clearance for its O3 Regional Oximeter, […]

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FDA Cleared Radiology Robotics

FDA Clears the XACT Robot for CT-Guided Percutaneous Procedures

The hands-free, tablet-sized robot with the potential to democratize percutaneous interventional procedures is on the verge of […]

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FDA Cleared MedTech

FDA clears ClearMask transparent surgical mask

ClearMask announced today that it received FDA 510(k) clearance for its ClearMask fully transparent surgical mask […]

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FDA Cleared Implantables Orthopedic

IlluminOss Medical gains expanded FDA clearance for fracture treatment system

IlluminOss Medical today said it received expanded FDA 510(k) clearance for its Photodynamic Bone Stabilization […]

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FDA Cleared Imaging MedTech

Swoop Portable MRI Cleared in U.S. for Bedside Scans

Magnetic resonance imaging (MRI) has become an integral part of medical care throughout much of […]

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AI FDA Cleared Radiology

FDA clears RapidAI's occlusion-spotting stroke software for CT scans

RapidAI has secured an FDA clearance for its artificial intelligence algorithms that quickly parse brain CT […]

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FDA Cleared Patient Monitoring

FDA clears Masimo device for ventilated patients

Masimo (NSDQ:MASI) announced today that it received FDA clearance for its PVi for fluid responsiveness indication […]

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Diagnostics FDA Cleared Oncology

Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS

Dive Brief: FDA Friday approved Guardant Health’s liquid biopsy diagnostic that uses next-generation sequencing (NGS) […]

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Topic: FDA Cleared

Caretaker Medical wearable patient monitor wins Health Canada clearance for COVID-19

Respiratory Health company AireHealth lands 510(k) for connected nebulizer

Alivecor wins FDA clearance for next-gen interpretive ECG algorithms

FDA clears Think Surgical’s second-gen robotic knee surgery system

OtoSet Automatic Ear Cleaning Device FDA Cleared

Allotrope Medical Announces FDA Clearance of StimSite™

Lantheus gains FDA clearance for bone scan AI

FDA Clears Most Powerful Clinical MRI

FDA grants De Novo clearance to prescription Apple Watch app for nightmare disorder

Medtronic wins FDA clearance for nerve monitoring system, acquires Ai Biomed

FDA clears Life Spine revision device

Siemens Ysio Max Digital Radiography System FDA Cleared

FDA clears AI for Vida Diagnostics lung imaging analysis software

FDA clears Tyber Medical foot and ankle plating system

Aidoc Wins Clearance for AI Solution that Flags Incidental Pulmonary Embolism

FDA clears Origami Surgical suture-delivery device

GE Healthcare Combines Ultrasound and AI for Cardio Exam Solution

Olympus gains 510(k) clearance for colonoscopes

BD’s automated flow cytometry system wins FDA clearance

Orthofix FIREBIRD SI fusion system receives additional US FDA clearance for nanotechnology

SurGenTec wins FDA nod for 3D GraftRasp system

FDA Clears Masimo’s Go Anywhere Pulse Oximeter and Respiration Rate Monitor

FDA clears Masimo’s Rad-G pulse oximeter

Philips launches thrombectomy system

RTI Surgical gains 510(k) clearance for compression plate

Cognoa Makes Push to Get FDA Nod for Digital Autism Diagnostic

Intersect ENT strikes €60 Fiagon buyout to expand in balloon sinuplasty

FDA clears Capsule Technologies’ addition of Masimo tech to patient monitor

Capsule Technologies earns FDA green light on capnography monitor

B-Temia wins FDA clearance for mobility exoskeleton

Minnetronix Medical wins FDA clearance for neurosurgical access port

Masimo scores extended FDA clearance for cerebral hemoglobin monitoring

FDA Clears the XACT Robot for CT-Guided Percutaneous Procedures

FDA clears ClearMask transparent surgical mask

IlluminOss Medical gains expanded FDA clearance for fracture treatment system

Swoop Portable MRI Cleared in U.S. for Bedside Scans

FDA clears RapidAI's occlusion-spotting stroke software for CT scans

FDA clears Masimo device for ventilated patients

Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS