FDA Cleared Archives - Page 3 of 10 - TMG Pulse

LiveMetric’s blood-pressure ‘smartwatch’ device gets FDA clearance

Dive Brief: A smartwatch-like blood-monitoring device made by LiveMetric that’s cuff-free was granted 510(k) clearance by the Food and […]

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FDA Cleared Robotics Surgery

Intuitive secures FDA clearance for lung biopsy robot featuring Siemens’ imaging tech

Dive Brief: The Food and Drug Administration has cleared the integration of Siemens Healthineers’ mobile imaging into […]

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FDA Cleared Healthcare MedTech

Invictus’s Aura Storm Air Purifier Receives FDA 510(k) Class II Medical Device Clearance

HICKORY, N.C., June 29, 2022 /PRNewswire/ — Invictus Sterilization LLC., a Hickory, NC based provider of Hospital-Grade UV-C based […]

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FDA Cleared Implantables Spine

SI-Bone receives FDA 510(k) clearance for iFuse Bedrock Granite

SI-Bone has announced that it has received US Food and Drug Administration (FDA) 510(k) premarket […]

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Cardiology FDA Cleared Structural Heart

Is Acutus Back on Solid Ground with New FDA Nod?

Acutus Medical is putting 2021 behind it with a new nod from FDA. The Carlsbad, […]

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FDA Cleared Healthcare Spine

Altus Spine announces FDA clearance of Sochi OCT system

Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) […]

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FDA Cleared Gastroenterology Wearables

Alimetry gets FDA clearance for wearable gut disorder test

Auckland-based health technology startup Alimetry has received clearance from the US Food and Drug Administration […]

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Diagnostics FDA Cleared MedTech

EarliTec Diagnostics receives FDA clearance for autism diagnosis support tool

EarliTec Diagnostics announced it has received FDA 510(k) clearance for a device that helps clinicians identify autism spectrum […]

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Diagnostics FDA Cleared MedTech

AI-powered scope developer says new FDA clearance opens the door for telehematology

Scopio Labs today announced FDA 510(k) clearance for its X100HT, which features a new slide […]

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FDA Cleared Spine Surgery

Altus Spine announces FDA clearance of Monaco HA pedicle screw system

Altus Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) […]

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FDA Cleared Spine Surgery

Stryker receives FDA clearance for Q Guidance System

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

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FDA Cleared Imaging Orthopedic

Accelus receives US FDA 510(k) clearance for its Toro-L interbody fusion system

Accelus has received 510(k) clearance from the US Food and Drug Administration (FDA) for its […]

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Diabetes FDA Cleared Patient Monitoring

FDA clears Abbott’s next-gen FreeStyle Libre 3 14-day CGM

Abbott (NYSE:ABT) announced today that it received FDA clearance for its next-generation FreeStyle Libre 3 continuous […]

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FDA Cleared Neuro Surgery

CTL Amedica granted FDA 510(k) approval for Navigation Instrument System

CTL Amedica has received official 510(k) clearance from the US Food and Drug Administration (FDA) […]

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Cardiology FDA Cleared Structural Heart

inHeart wins FDA clearance for 3D cardiac modeling software

inHeart announced today that it received FDA 510(k) clearance for its inHeart Models software suite for […]

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FDA Cleared MedTech Surgery

Minnetronix Medical Sharpens Image Quality for the First FDA-Cleared Wireless Surgical Camera

ST. PAUL, Minn. — SAINT PAUL, Minn. (May 17, 2022) – Minnetronix Medical announces it was selected […]

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AI FDA Cleared Spine

Nanox receives FDA 510(k) clearance for its AI HealthOST device

Nanox has announced that its deep-learning medical imaging analytics subsidiary, Nanox.AI, recently received US Food […]

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FDA Cleared Robotics Surgery

XACT Robotics® Receives FDA Clearance that Expands Support for Ablation Procedures

Hingham, Mass., May 18, 2022 – XACT Robotics®, developer of the world’s first and only comprehensive […]

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FDA Cleared Orthopedic Surgery

FDA clears DePuy Synthes’ Inhance for total shoulder arthroplasty

Johnson & Johnson MedTech’s DePuy Synthes ortho device company announced today that its Inhance system […]

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AI Diagnostics FDA Cleared

Overjet expands its AI platform to help dentists detect cavities along with gum disease

Artificial intelligence has shown promise in many areas of healthcare, and dentistry is no exception. AI […]

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FDA Cleared Robotics Urology

Why Monarch’s New Clearance Is Big for J&J’s Surgical Robot

Ethicon, a Johnson & Johnson MedTech company, announced the news that should bring back some […]

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Cardiology FDA Cleared Wearables

FDA clears four new parameters for Caretaker Medical’s wireless patient monitoring system

Caretaker Medical announced that it received FDA 510(k) clearance for four new hemodynamic parameters for its […]

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FDA Cleared Implantables Orthopedic

FDA clears dorsal spanning plate from The Orthopaedic Implant Company

The Orthopaedic Implant Company (OIC) announced today that the FDA cleared its dorsal spanning plate. Reno, […]

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FDA Cleared Healthcare MedTech

Sanolla’s smart infrasound stethoscope wins FDA clearance

The startup Sanolla has won 510(k) clearance for the clinical use of the VoqX stethoscope. […]

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FDA Cleared MedTech Vascular

Truvic announces US FDA 510(k) clearance for Prodigy thrombectomy system

Truvic Medical, a wholly owned subsidiary of Imperative Care, announced in a press release that […]

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FDA Cleared MedTech Neuro

Aidoc gains FDA 510(k) clearance for AI-supported triage and notification of brain aneurysm

Aidoc has received US Food and Drug Administration (FDA) 510(k) clearance for the triage and […]

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FDA Cleared MedTech Vascular

Artio Medical wins FDA clearance for Solus Gold embolization device

Artio Medical this week announced it received FDA clearance for its Solus Gold embolization device […]

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FDA Cleared MedTech Vascular

FDA clears Cerus Endovascular 027 microcatheters

Cerus Endovascular this week announced the FDA 510(k) clearance of its 027 microcatheters. Fremont, California-based […]

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FDA Cleared MedTech Orthopedic

Shoulder Innovations wins FDA clearance for InSet stemless humeral implant

Shoulder Innovations today announced that it received FDA 510(k) clearance for its InSet stemless humeral […]

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FDA Cleared

FDA clears Fresenius Kabi wireless Agilia Connect infusion system

Fresenius Kabi announced today that it received FDA 510(k) clearance for its wireless Agilia Connect infusion […]

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FDA Cleared MedTech Patient Monitoring

With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?

When Dr. Fran Kaufman began her career in the late 1970s, diabetes management consisted of […]

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Cardiology FDA Cleared MedTech

Abbott wins FDA clearance for new cardiac mapping system

Abbott (NYSE:ABT) announced today that it received FDA clearance for its EnSite X EP with EnSite […]

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FDA Cleared MedTech

BD wins FDA clearance for microbiology bacterial identification testing automation platform

BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Kiestra IdentifA system for […]

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FDA Cleared MedTech

FDA clears Nobel Biocare’s N1 implant system

Envista (NYSE:NVST) announced today that the FDA cleared the Nobel Biocare N1 implant system of instruments, prosthetic components […]

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FDA Cleared MedTech Patient Monitoring

Medtronic cerebral/somatic oximetry system wins FDA clearance

Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its INVOS 7100 cerebral/somatic oximetry […]

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FDA Cleared Imaging MedTech

Philips scores FDA 510(k) for acute patient monitors

The IntelliVue MX750 and MX850 patient monitors received an EUA last year and a European CE mark in 2019.

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FDA Cleared MedTech Spine

CoreLink announces commercial launch of CentraFix midline fixation system

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

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FDA Cleared Imaging MedTech

Hyperfine Receives FDA Clearance for Deep Learning Portable MRI, Defining the Future of Life-Saving Diagnostics

World’s first portable MRI transforms imaging at the patient’s bedside with deep learning to enable timely diagnosis and treatment

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Cardiology Diagnostics Digital Health FDA Cleared Patient Monitoring

FDA clears AFib notification on Apple Watch

An FDA letter confirms that Apple (NSDQ:AAPL) received 510(k) clearance for an irregular heart rhythm notification on […]

Topic: FDA Cleared

LiveMetric’s blood-pressure ‘smartwatch’ device gets FDA clearance

Intuitive secures FDA clearance for lung biopsy robot featuring Siemens’ imaging tech

Invictus’s Aura Storm Air Purifier Receives FDA 510(k) Class II Medical Device Clearance

SI-Bone receives FDA 510(k) clearance for iFuse Bedrock Granite

Is Acutus Back on Solid Ground with New FDA Nod?

Altus Spine announces FDA clearance of Sochi OCT system

Alimetry gets FDA clearance for wearable gut disorder test

EarliTec Diagnostics receives FDA clearance for autism diagnosis support tool

AI-powered scope developer says new FDA clearance opens the door for telehematology

Altus Spine announces FDA clearance of Monaco HA pedicle screw system

Stryker receives FDA clearance for Q Guidance System

Accelus receives US FDA 510(k) clearance for its Toro-L interbody fusion system

FDA clears Abbott’s next-gen FreeStyle Libre 3 14-day CGM

CTL Amedica granted FDA 510(k) approval for Navigation Instrument System

inHeart wins FDA clearance for 3D cardiac modeling software

Minnetronix Medical Sharpens Image Quality for the First FDA-Cleared Wireless Surgical Camera

Nanox receives FDA 510(k) clearance for its AI HealthOST device

XACT Robotics® Receives FDA Clearance that Expands Support for Ablation Procedures

FDA clears DePuy Synthes’ Inhance for total shoulder arthroplasty

Overjet expands its AI platform to help dentists detect cavities along with gum disease

Why Monarch’s New Clearance Is Big for J&J’s Surgical Robot

FDA clears four new parameters for Caretaker Medical’s wireless patient monitoring system

FDA clears dorsal spanning plate from The Orthopaedic Implant Company

Sanolla’s smart infrasound stethoscope wins FDA clearance

Truvic announces US FDA 510(k) clearance for Prodigy thrombectomy system

Aidoc gains FDA 510(k) clearance for AI-supported triage and notification of brain aneurysm

Artio Medical wins FDA clearance for Solus Gold embolization device

FDA clears Cerus Endovascular 027 microcatheters

Shoulder Innovations wins FDA clearance for InSet stemless humeral implant

FDA clears Fresenius Kabi wireless Agilia Connect infusion system

With FDA clearance ‘imminent’ for Senseonics 180-day CGM, what’s next?

Abbott wins FDA clearance for new cardiac mapping system

BD wins FDA clearance for microbiology bacterial identification testing automation platform

FDA clears Nobel Biocare’s N1 implant system

Medtronic cerebral/somatic oximetry system wins FDA clearance

Philips scores FDA 510(k) for acute patient monitors

CoreLink announces commercial launch of CentraFix midline fixation system

Hyperfine Receives FDA Clearance for Deep Learning Portable MRI, Defining the Future of Life-Saving Diagnostics

FDA clears AFib notification on Apple Watch