FDA Cleared Archives - Page 2 of 10 - TMG Pulse

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FDA Cleared MedTech Therapeutics

FDA clears heat purification, remote therapy from Fresenius

Fresenius Medical Care North America (FMCNA) recently announced FDA clearances for two of its technologies used […]

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FDA Cleared MedTech Spine

ulrich Medical USA receives 510(k) clearance for Flux-C 3D implant

ulrich medical USA has received 510(k) clearance from the US Food and Drug Administration (FDA) for […]

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FDA Cleared Minimally Invasive Spine

DePuy Synthes receives FDA clearance for TELIGEN system

DePuy Synthes, the orthopedics company of Johnson & Johnson, has secured 510(k) clearance from the […]

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FDA Cleared MedTech Ophthalmology

NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching

Dive Brief: NovaSight’s digital treatment for amblyopia, also known as lazy eye, has been cleared for use in […]

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FDA Cleared Minimally Invasive Spine

Aurora Spine receives FDA clearance for its SiLO TFX MIS sacroiliac joint fixation system

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

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FDA Cleared MedTech Spine

Ventris Medical receives 510(k) clearance for Amplify standalone bone graft putty and bone graft extender

Ventris Medical has announced that the US Food and Drug Administration (FDA) has granted it […]

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FDA Cleared Minimally Invasive Spine

FDA clears sacroiliac joint fixation system from Aurora Spine

Aurora Spine (OTCQB:ASAPF) announced that it received FDA 510(k) clearance for its SiLO TFX MIS sacroiliac […]

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Cardiology FDA Cleared Surgery

DyAnsys’ neurostimulation device receives FDA clearance to treat post-cardiac surgery pain

California-based DyAnsys, a medical device company specializing in the autonomous nervous system, has announced that […]

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FDA Cleared Implantables Surgery

DURAMESH Suture Receives FDA Nod

Mesh Suture, d.b.a. MSi, today announced the FDA 510(k) clearance for DURAMESH, a non-absorbable polypropylene mesh […]

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Clinical Trial FDA Cleared Neuro

Magnus receives US FDA clearance for SAINT neuromodulation system in severe depression treatment

Magnus Medical has announced receipt of 510(k) clearance from the US Food and Drug Administration […]

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Diagnostics FDA Cleared Wearables

Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide

Australian company Seer Medical received FDA 510(k) clearance for its at-home electroencephalograph (EEG) system Seer Home that […]

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CE Mark FDA Cleared Neuro

ClearPoint Neuro to commercialize FDA-cleared neuro laser

ClearPoint Neuro (Nasdaq: CLPT) announced today that the FDA has cleared its Swedish partner Clinical […]

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FDA Cleared Orthopedic Surgery

Zimmer Biomet gets FDA clearance for Identity shoulder system

Zimmer Biomet announced Tuesday that it received 510(k) clearance from the Food and Drug Administration for […]

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AR/VR FDA Cleared Spine

Augmedics celebrates completion of 2,000th xvision case

Augmedics has announced the milestone achievement of 2,000 commercial cases completed utilizing its xvision spine […]

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Algorithm FDA Cleared Neuro

FDA clears Viz.ai’s RV/LV ratio algorithm

Viz.ai has received US Food and Drug Administration (FDA) 510(k) clearance for an automated right […]

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FDA Cleared Orthopedic Spine

NeuraMedica receives FDA 510(k) clearance for DuraFuse dural clips

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

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Drug-delivery FDA Cleared MedTech

FDA clears syringe infusion pump with Dose IQ software from Baxter

Baxter (NYSE:BAX) announced today that the FDA issued 510(k) clearance to its Novum IQ infusion […]

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FDA Cleared Spine Surgery

Surgalign announces FDA 510(k) clearance of the Cortera spinal fixation system

Surgalign has received US Food and Drug Administration (FDA) 510(k) clearance of its Cortera spinal fixation […]

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FDA Cleared Implantables Spine

FDA clears Surgalign’s Cortera spinal fixation system

Surgalign (Nasdaq:SRGA) announced today that it received FDA 510(k) clearance for its Cortera spinal fixation system. […]

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FDA Cleared Implantables Spine

Zavation Medical Products receives FDA 510(k) clearance for Varisync anterior cervical plate and spacer system

Zavation Medical Products has received US Food and Drug Administration (FDA) 510(k) clearance of Varisync, a cervical […]

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FDA Cleared Minimally Invasive Robotics

Sky’s the Limit for Newly Cleared Robotic-Assisted Surgery System

The recent trend of robotic-assisted surgery (RAS) systems gaining a nod from FDA has continued […]

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Diabetes Drug-delivery FDA Cleared

FDA clears Insulet Omnipod 5 for children two years and older

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet] Insulet (Nasdaq:PODD) announced today […]

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FDA Cleared Implantables Spine

VyPlate anterior cervical plate system granted FDA clearance

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

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FDA Cleared Ophthalmology Public Offering

Visibly receives FDA clearance for online visual acuity test

Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test. […]

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Cardiology FDA Cleared Imaging

Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio

Dyad Medical today announced it received FDA 510(k) clearance for its echocardiogram application Echo:Prio. The Boston-based […]

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FDA Cleared MedTech Neuro

NeuroOne submits special 510(k) to US FDA for Evo sEEG electrode

NeuroOne Medical Technologies has announced the submission of a special 510(k) to the US Food […]

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FDA Cleared Imaging Radiology

Xoran wins FDA clearance for mobile fluoroscopy CT system

Xoran Technologies announced today that it received FDA 510(k) clearance for its TRON computed tomography (CT) […]

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AI FDA Cleared Neuro

FDA clears Viz.ai’s algorithm that detects subdural hemorrhage

Viz.ai announced today that it received FDA 510(k) clearance for its Viz Subdural (SDH) artificial intelligence […]

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Digital Health FDA Cleared Respiratory

Adherium gets US FDA 510(k) to connect remote monitoring sensor for Ellipta inhaler users

Adherium, a New Zealand-based maker of connected respiratory medical devices, has received the US Food […]

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AI FDA Cleared Neuro

Viz.ai receives US FDA 510(k) clearance for Viz SDH, announces Hyperfine partnership

Viz.ai today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for […]

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FDA Cleared MedTech Neuro

Rapid Medical gains US FDA clearance for “smallest and only” adjustable thrombectomy device

Rapid Medical announced at the ongoing Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 […]

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AI FDA Cleared Imaging

Exo Simplifies Medical Imaging with New M&A

Exo said it is acquiring Medo, a Canadian developer of artificial intelligence (AI) technology, to […]

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Dermatology FDA Cleared MedTech

After Regulatory Bumps, Apex Wins FDA Nod Renuvion

Apex Medical, the manufacturer of Renuvion, a helium plasma and radiofrequency (RF) technology, recently announced receipt of […]

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Cardiology FDA Cleared Machine Learning

Eko receives FDA clearance for heart murmur analysis algorithm

Smart stethoscope company Eko last week announced it has received FDA 510(k) clearance for an algorithm that […]

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FDA Cleared Implantables Orthopedic

Onkos wins FDA clearance for 3D-printed pelvic reconstruction system

Onkos Surgical announced today that the FDA has cleared its My3D personalized pelvic reconstruction system. […]

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FDA Cleared Orthopedic Spine

Cutting Edge Spine announces received FDA 510(k) clearance of T-FIX 3DSI joint fusion system

Cutting Edge Spine has announced that it has received US Food and Drug Administration (FDA) […]

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Cardiology FDA Cleared Wearables

LiveMetric receives FDA 510(k) for watch-like blood pressure monitor

LiveMetric announced it has received FDA 510(k) clearance for its watch-like blood pressure monitor, LiveOne. […]

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Digital Health FDA Cleared Patient Monitoring

ResApp gets 510(k) clearance for mobile sleep apnea test SleepCheck

ASX-listed ResApp Health has received the US Food and Drug Administration’s 510(k) clearance for SleepCheckRx, […]

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FDA Cleared Spine Surgery

Xenco Medical launches Multilevel CerviKit

Xenco Medical has expanded its ambulatory surgery centre (ASC) surgical device portfolio through the US […]

Topic: FDA Cleared

FDA clears heat purification, remote therapy from Fresenius

ulrich Medical USA receives 510(k) clearance for Flux-C 3D implant

DePuy Synthes receives FDA clearance for TELIGEN system

NovaSight’s digital treatment for lazy eye gets FDA nod, providing alternative to patching

Aurora Spine receives FDA clearance for its SiLO TFX MIS sacroiliac joint fixation system

Ventris Medical receives 510(k) clearance for Amplify standalone bone graft putty and bone graft extender

FDA clears sacroiliac joint fixation system from Aurora Spine

DyAnsys’ neurostimulation device receives FDA clearance to treat post-cardiac surgery pain

DURAMESH Suture Receives FDA Nod

Magnus receives US FDA clearance for SAINT neuromodulation system in severe depression treatment

Seer Medical receives FDA 510(k) for its at-home epilepsy diagnosis aide

ClearPoint Neuro to commercialize FDA-cleared neuro laser

Zimmer Biomet gets FDA clearance for Identity shoulder system

Augmedics celebrates completion of 2,000th xvision case

FDA clears Viz.ai’s RV/LV ratio algorithm

NeuraMedica receives FDA 510(k) clearance for DuraFuse dural clips

FDA clears syringe infusion pump with Dose IQ software from Baxter

Surgalign announces FDA 510(k) clearance of the Cortera spinal fixation system

FDA clears Surgalign’s Cortera spinal fixation system

Zavation Medical Products receives FDA 510(k) clearance for Varisync anterior cervical plate and spacer system

Sky’s the Limit for Newly Cleared Robotic-Assisted Surgery System

FDA clears Insulet Omnipod 5 for children two years and older

VyPlate anterior cervical plate system granted FDA clearance

Visibly receives FDA clearance for online visual acuity test

Dyad Medical wins FDA clearance for cardiac imaging platform Echo:Prio

NeuroOne submits special 510(k) to US FDA for Evo sEEG electrode

Xoran wins FDA clearance for mobile fluoroscopy CT system

FDA clears Viz.ai’s algorithm that detects subdural hemorrhage

Adherium gets US FDA 510(k) to connect remote monitoring sensor for Ellipta inhaler users

Viz.ai receives US FDA 510(k) clearance for Viz SDH, announces Hyperfine partnership

Rapid Medical gains US FDA clearance for “smallest and only” adjustable thrombectomy device

Exo Simplifies Medical Imaging with New M&A

After Regulatory Bumps, Apex Wins FDA Nod Renuvion

Eko receives FDA clearance for heart murmur analysis algorithm

Onkos wins FDA clearance for 3D-printed pelvic reconstruction system

Cutting Edge Spine announces received FDA 510(k) clearance of T-FIX 3DSI joint fusion system

LiveMetric receives FDA 510(k) for watch-like blood pressure monitor

ResApp gets 510(k) clearance for mobile sleep apnea test SleepCheck

Xenco Medical launches Multilevel CerviKit