FDA Cleared Archives - TMG Pulse

FDA clears Samsung Galaxy smart watch for AFib detection

Samsung Electronics announced that the irregular heart rhythm notification feature of its health monitor app received […]

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Cardiology FDA Cleared Patient Monitoring

Smart Toilet Seat Wins FDA Nod to Monitor Heart Rate

Casana has developed a unique way of measuring a person’s heart rate and oxygen saturation. […]

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FDA Cleared Robotics Surgery

FDA clears Intuitive da Vinci surgical robot for prostatectomy

Intuitive Surgical(Nasdaq: ISRG)+ announced today that the FDA cleared its da Vinci SP surgical robot for […]

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FDA Cleared MedTech Patient Monitoring

FDA clears vascular biometric monitor from CardieX

CardieX announced today that it received FDA 510(k) clearance for its Conneqt Pulse vital signs […]

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Cardiology FDA Cleared Healthcare

Abbott wins duo of FDA clearances for CentriMag life support system

Abbott(NYSE: ABT)+ announced today that it received two FDA clearances for its CentriMag system for life […]

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FDA Cleared Imaging Surgery

FDA clears surgical navigation system from Proprio

Proprio announced today that it received FDA 510(k) clearance for its Paradigm surgical navigation platform. […]

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Catheters FDA Cleared Vascular

Route 92 gains US FDA clearance for complete stroke treatment system

Route 92 Medical has today announced receipt of 510(k) clearance from the US Food and […]

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FDA Cleared Healthcare Patient Monitoring

FDA clears Carescape Canvas patient monitoring platform from GE HealthCare

GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Carescape Canvas patient […]

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FDA Cleared Patient Monitoring Respiratory

Maxtec Oxygen & Pressure Monitor Receives FDA Clearance, Now Available in U.S. Market

SALT LAKE CITY — Maxtec, a global leading manufacturer of respiratory care products, is excited […]

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FDA Cleared Imaging Neuro

RapidAI receives US FDA 510(k) clearance for new imaging product to accelerate acute stroke triage

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

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Diabetes FDA Cleared Patient Monitoring

FDA clears reader for next-gen Abbott FreeStyle Libre 3

Abbott (NYSE:ABT) announced today that the FDA cleared a reader device for its FreeStyle Libre 3 […]

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FDA Cleared Implantables Neuro

FDA clears Neuspera Medical peripheral nerve stim

Neuspera Medical this week announced its ultra-miniaturized neurostimulator system received FDA clearance. The Neuspera system […]

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Catheters FDA Cleared Ophthalmology

FDA clears iTrack Advance canaloplasty device from Nova Eye Medical

Nova Eye Medical announced today that it received FDA 510(k) clearance for its new iTrack […]

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FDA Cleared MedTech Neuro

Neuronetics enhances NeuroStar connectivity with Wi-Fi capabilities

Neuronetics (Nasdaq:STIM) announced that it implemented improved internet connectivity capabilities across its NeuroStar platform. Malvern, Pennsylvania-based […]

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FDA Cleared Funding Patient Monitoring

Indian RPM startup Dozee gets $6M to kickstart global expansion

Indian medical device startup Dozee has raised $6 million in a Series A2 funding round, […]

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AI FDA Cleared Imaging

FDA clears AI-enabled lung ultrasound tech from Butterfly Network

Butterfly Network (NYSE:BFLY) announced today that it received FDA 510(k) clearance for an AI-enabled auto B-line […]

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Cardiology FDA Cleared

Abbott Continues Its Sterling 2023 with Epic Max FDA Clearance

Abbott continues its positive start to 2023 with FDA clearance of its Epic Max stented […]

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FDA Cleared Implantables

Woven Orthopedic Technologies granted 510(k) clearance for Ogmend implant enhancement system

Woven Orthopedic Technologies has announced that its Ogmend implant enhancement system has received 510(k) clearance […]

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FDA Cleared Spine Surgery

Accelus Announces FDA 510(k) clearance of Remi robotic navigation system for use with 2D fluoroscopy-based imaging system

Accelus has announced that the US Food & Drug Administration (FDA) has issued it 510(k) […]

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FDA Cleared Neuro Therapeutics

GrayMatters Health Earns FDA Clearance for PTSD Neuromodulation Device

The Food and Drug Administration recently cleared the first non-invasive, self-neuromodulation digital therapy for […]

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FDA Cleared MedTech Neuro

Prolira secures FDA clearance for its DeltaScan brain state monitor

Prolira (Utrecht, the Netherlands) announced today that the FDA has cleared its brain state monitor […]

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Digital Health FDA Cleared Respiratory

TytoCare receives FDA 510(k) for wheeze detection software

Virtual primary care company TytoCare received FDA 510(k) clearance for clinical decision support software that […]

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Catheters FDA Cleared Neuro

Scientia receives US FDA clearance for Aristotle Colossus macrowire

Scientia Vascular has announced the US Food and Drug Administration (FDA) 510(k) clearance of the […]

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AI FDA Cleared Spine

AI is part of Augmedics’ Xvision Spine System expansion

Augmedics announced today that it launched new, FDA-cleared features and indications for its Xvision Spine System. […]

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FDA Cleared Robotics Surgery

FDA clears surgical robot from Noah Medical

Noah Medical announced that it received FDA clearance for its Galaxy System for robotic-navigated bronchoscopy. San […]

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FDA Cleared Neuro Wearables

Theranica receives FDA 510(k) for migraine prevention device

Prescription digital therapeutic developer Theranica announced it has received FDA 510(k) clearance to use its Nerivio device […]

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Cardiology Digital Health FDA Cleared

RapidAI receives FDA 510(k) for another pulmonary embolism tool

RapidAI, a health tech company specializing in imaging analysis software, announced it received FDA 510(k) […]

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Catheters FDA Cleared MedTech

Perfuze announces US FDA clearance and first US clinical use of Millipede 088 access catheter

Perfuze has secured its first product clearance from the US Food and Drug Administration (FDA) […]

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Clinical Trial FDA Cleared Neuro

Wallaby/Phenox announces presentation of PROST trial data at ISC 2023

Phenox, a Wallaby Medical company, has today announced the presentation of the primary results of […]

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3D Printing Dentistry FDA Cleared

Stratasys has its first FDA-cleared medical device

Stratasys (NASDAQ: SSYS) today introduced its TrueDent resin for making 3D-printed dentures. TrueDent is the first FDA-cleared […]

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Diabetes Drug-delivery FDA Cleared

Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor

Know Labs (NYSE:KNW) announced that it entered into a series of strategic partnerships as it looks […]

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Diabetes Drug-delivery FDA Cleared

Tidepool Loop automated insulin delivery system wins FDA clearance

Tidepool announced recently that the FDA cleared its Tidepool Loop, a “do-it-yourself,” (DIY) automated insulin […]

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FDA Cleared Oncology Radiology

FDA clears biology-guided radiotherapy from RefleXion

RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer. Hayward, […]

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FDA Cleared Minimally Invasive Neuro

phenox Inc. a Wallaby Medical Company, announces the FDA 510k Clearance of the pRESET® Thrombectomy Device for the treatment of acute ischemic stroke.

[Irvine, CA] – phenox Inc., a leading medical device company in the Neurovascular industry, announced […]

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Diabetes Digital Health FDA Cleared

Tidepool’s diabetes management tool receives 510(k) clearance

Nonprofit diabetes management startup Tidepool received 510(k) clearance for its Tidepool Loop, an automated insulin dosing app […]

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FDA Cleared Orthopedic Surgery

Icotec wins FDA clearance for Vader pedicle screws

Icotec this week announced it received FDA 510(k) clearance to market its Vader pedicle screw […]

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FDA Cleared Orthopedic Spine

Astura Medical receives FDA 510(k) clearance for El Capitan X expandable anterior lumbar interbody system

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

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FDA Cleared Orthopedic Spine

VySpine receives FDA clearance for LumiVy NanoVy Ti Lumbar IBF system

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

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Diabetes FDA Cleared MedTech

How Dexcom aims to extend its mission beyond diabetes

CEO Kevin Sayer explains how, following the launch of the next-generation Dexcom G7, the company […]

Topic: FDA Cleared

FDA clears Samsung Galaxy smart watch for AFib detection

Smart Toilet Seat Wins FDA Nod to Monitor Heart Rate

FDA clears Intuitive da Vinci surgical robot for prostatectomy

FDA clears vascular biometric monitor from CardieX

Abbott wins duo of FDA clearances for CentriMag life support system

FDA clears surgical navigation system from Proprio

Route 92 gains US FDA clearance for complete stroke treatment system

FDA clears Carescape Canvas patient monitoring platform from GE HealthCare

Maxtec Oxygen & Pressure Monitor Receives FDA Clearance, Now Available in U.S. Market

RapidAI receives US FDA 510(k) clearance for new imaging product to accelerate acute stroke triage

FDA clears reader for next-gen Abbott FreeStyle Libre 3

FDA clears Neuspera Medical peripheral nerve stim

FDA clears iTrack Advance canaloplasty device from Nova Eye Medical

Neuronetics enhances NeuroStar connectivity with Wi-Fi capabilities

Indian RPM startup Dozee gets $6M to kickstart global expansion

FDA clears AI-enabled lung ultrasound tech from Butterfly Network

Abbott Continues Its Sterling 2023 with Epic Max FDA Clearance

Woven Orthopedic Technologies granted 510(k) clearance for Ogmend implant enhancement system

Accelus Announces FDA 510(k) clearance of Remi robotic navigation system for use with 2D fluoroscopy-based imaging system

GrayMatters Health Earns FDA Clearance for PTSD Neuromodulation Device

Prolira secures FDA clearance for its DeltaScan brain state monitor

TytoCare receives FDA 510(k) for wheeze detection software

Scientia receives US FDA clearance for Aristotle Colossus macrowire

AI is part of Augmedics’ Xvision Spine System expansion

FDA clears surgical robot from Noah Medical

Theranica receives FDA 510(k) for migraine prevention device

RapidAI receives FDA 510(k) for another pulmonary embolism tool

Perfuze announces US FDA clearance and first US clinical use of Millipede 088 access catheter

Wallaby/Phenox announces presentation of PROST trial data at ISC 2023

Stratasys has its first FDA-cleared medical device

Know Labs inks partnerships to accelerate progress toward FDA clearance for glucose monitor

Tidepool Loop automated insulin delivery system wins FDA clearance

FDA clears biology-guided radiotherapy from RefleXion

phenox Inc. a Wallaby Medical Company, announces the FDA 510k Clearance of the pRESET® Thrombectomy Device for the treatment of acute ischemic stroke.

Tidepool’s diabetes management tool receives 510(k) clearance

Icotec wins FDA clearance for Vader pedicle screws

Astura Medical receives FDA 510(k) clearance for El Capitan X expandable anterior lumbar interbody system

VySpine receives FDA clearance for LumiVy NanoVy Ti Lumbar IBF system

How Dexcom aims to extend its mission beyond diabetes