FDA Cleared Archives - TMG Pulse

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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 […]

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FDA Cleared Implantables Spine

NanoHive receives FDA 510(k) clearance for Hive standalone cervical system

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

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FDA Cleared Orthopedic Pediatrics

Arthrex wins FDA clearance for TightRope implant for pediatric ACL surgery

Arthrex announced today that it received FDA clearance for pediatric indications for its anterior cruciate ligament […]

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Algorithm FDA Cleared Vascular

FDA clears Lightning Flash thrombectomy system from Penumbra

Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system. […]

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AR/VR FDA Cleared Spine

Surglasses receives FDA 510(k) clearance for Caduceus S AR spine navigation system

Surglasses has announced that its Caduceus S augmented reality (AR) spine navigation system has received […]

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FDA Cleared Implantables Spine

SI-Bone announces FDA clearance for expanded rod compatibility with the iFuse Bedrock Granite implant system

SI-Bone has announced additional US Food and Drug Administration (FDA) clearance for its iFuse Bedrock […]

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FDA Cleared MedTech Respiratory

Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment

Dive Brief: Vivos Therapeutics has received 510(k) clearance of a daytime-nighttime appliance, known as a DNA appliance, […]

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FDA Cleared Implantables Spine

Si-Bone wins expanded FDA clearance for iFuse Bedrock Granite implant

Si-Bone (Nasdaq:SIBN) announced today that it received additional FDA clearance for its iFuse Bedrock Granite implant. […]

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FDA Cleared Robotics Surgery

Moon Surgical wins first FDA 510(k) clearance for surgical robot

Moon Surgical announced today that it received FDA 510(k) clearance for its Maestro surgical robotics system. […]

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Diabetes Drug-delivery FDA Cleared

FDA clears Mallya smart insulin pen device from Biocorp

Biocorp announced today that it received FDA 510(k) clearance to market its Mallya smart medical […]

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Cardiology FDA Cleared Machine Learning

Ultromics scores FDA 510(k) for AI-based heart failure detection aide

UK-based Ultromics announced Tuesday that its machine learning-based decision-support system used to help detect heart failure with […]

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AR/VR FDA Cleared Surgery

Mixed reality surgical training platform apoQlar receives FDA clearance

German company apoQlar announced its plans to raise Series A funding after receiving FDA 510(k) […]

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FDA Cleared MedTech Pediatrics

Rockfield Medical Devices Receives FDA Clearance for the Mobility+ Enteral Feeding System

GALWAY, Ireland, Nov. 15, 2022 /PRNewswire/ — Rockfield Medical Devices Limited, a commercial-stage medical device company focused on […]

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AI FDA Cleared Neuro

Rapid ICH receives new US FDA clearance with “highest sensitivity and specificity on the market”

RapidAI has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the […]

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Audiology FDA Cleared Pediatrics

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical’s Greg Mielke

Preceptis Medical, a medtech company based in Minnesota, created the Hummingbird Tympanostomy Tube System. The […]

Topic: FDA Cleared

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

NanoHive receives FDA 510(k) clearance for Hive standalone cervical system

Arthrex wins FDA clearance for TightRope implant for pediatric ACL surgery

FDA clears Lightning Flash thrombectomy system from Penumbra

Surglasses receives FDA 510(k) clearance for Caduceus S AR spine navigation system

SI-Bone announces FDA clearance for expanded rod compatibility with the iFuse Bedrock Granite implant system

Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment

Si-Bone wins expanded FDA clearance for iFuse Bedrock Granite implant

Moon Surgical wins first FDA 510(k) clearance for surgical robot

FDA clears Mallya smart insulin pen device from Biocorp

Ultromics scores FDA 510(k) for AI-based heart failure detection aide

Mixed reality surgical training platform apoQlar receives FDA clearance

Rockfield Medical Devices Receives FDA Clearance for the Mobility+ Enteral Feeding System

Rapid ICH receives new US FDA clearance with “highest sensitivity and specificity on the market”

In-Office Pediatric Ear Tube Procedures: Interview with Preceptis Medical’s Greg Mielke