FDA Archives - Page 2 of 15 - TMG Pulse

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FDA Orthopedic Spine

CAVUX facet fixation system granted FDA approval for the treatment of cervical pseudarthrosis

Providence Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared […]

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FDA Radiology Sensors

FDA Grants New Approval for Essential Tremor Treatment from Insightec

Insightec announced today that it received additional FDA approval for treating essential tremor with its Exablate […]

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FDA Implantables Spine

Abbott Snags Eterna SCS FDA Greenlight

Abbott has obtained FDA clearance of its Eterna spinal cord stimulation (SCS) system for the treatment […]

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FDA Implantables MedTech

A Medical Device FDA Clearance for the History Books

Back in 2013, Oxford Performance Materials made Medtech history by scoring the first FDA clearance […]

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FDA Public Offering Spine

Saluda Medical initiates US commercialization of the Evoke spinal cord stimulation system

Saluda Medical has announced plans for a limited commercial release of its Evoke spinal cord […]

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FDA Genomics Therapeutics

FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer

Bladder cancer can be treated with several types of drugs. Gene therapy is now part […]

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Digital Therapeutics FDA IDE

Click wins FDA breakthrough designation for prescription digital migraine therapy

Dive Brief: Click Therapeutics has received breakthrough device status for its prescription digital migraine therapy. The Food […]

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FDA Implantables Spine

TruLift lateral expandable spacer system and lateral plate system granted FDA approval

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

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Diabetes FDA Patient Monitoring

Dexcom’s G7 glucose monitor wins awaited FDA clearance

Dive Brief: Dexcom received clearance from the Food and Drug Administration for its G7 continuous […]

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AI FDA Oncology

Avenda Health receives FDA clearance for AI support software for prostate cancer

Avenda Health received FDA 510(k) clearance for AI-backed clinical decision support software that assists physicians […]

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FDA Patient Monitoring Wearables

ChroniSense Medical receives FDA 510(k) for RPM wearable

Israeli company ChroniSense Medical received FDA 510(k) clearance for its Polso wearable that collects and […]

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Cardiology FDA Radiology

Imagen Technologies wins FDA nod for computer-assisted detection device

Imagen Technologies announced today that the FDA cleared its computer-assisted detection (CADe) device, Aorta-CAD. New York-based […]

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FDA Neuro Patient Monitoring

FDA clears cortical neuromonitoring strip from Wise

Wise announced today that it received FDA clearance for its Wise Cortical Strip (WCS) for […]

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FDA Leadership MedTech

Swiss parliament votes to accept US FDA-approved medical devices

The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food […]

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FDA Imaging Radiology

FDA clears mobile CT scanner from Samsung’s NeuroLogica

NeuroLogica — a Samsung Electronics subsidiary — announced today that it received FDA 510(k) clearance for its […]

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AI FDA MedTech

Avicenna.AI partners with CARPL.ai to provide AI-powered radiology solutions

Avicenna.AI has today announced a distribution agreement with CARPL.ai—a company providing a technology platform that […]

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FDA Implantables Orthopedic

Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement

Dive Brief: Zimmer Biomet received 510(k) clearance for its Persona OsseoTi Keel Tibia for cementless knee replacement. […]

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Diabetes FDA Ophthalmology

AEYE Health receives FDA 510(k) for AI-backed diabetic retinopathy screening

Israeli startup AEYE Health announced last week it had received FDA 510(k) clearance for its […]

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FDA Patient Monitoring Wearables

Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance

Dive Brief: H2o Therapeutics has received 510(k) clearance for an Apple Watch app that monitors Parkinson’s disease […]

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FDA MedTech Respiratory

LivaNova LifeSparc ACS pump cleared for extended use

LivaNova (Nasdaq: LIVN) says a new FDA clearance expands how long health providers can use […]

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FDA Implantables Spine

Centinel Spine announces first commercial use of prodisc C SK cervical total disc replacement device

Centinel Spine has announced the first implantation of its prodisc C SK cervical total disc replacement […]

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FDA Robotics Spine

Accelus announces FDA clearance for Remi robotic navigation system software update

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

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AI FDA Spine

Nevro announces US FDA approval of HFX iQ system to personalize chronic pain treatment

Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) […]

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Audiology FDA Public Offering

OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price

Dive Brief: Nuheara has received 510(k) clearance for a self-fitting over-the-counter hearing aid, positioning it to bring […]

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Diagnostics FDA Sensors

BioIntelliSense adds skin-color sensitive pulse oximeter amid FDA concerns over fingertip devices

Dive Brief: Optical sensor solution in fingertip monitors gives medical-grade accuracy of oxygen level measurement […]

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FDA Neuro Therapeutics

Sinaptica Looks to Treat Alzheimer’s Disease Symptoms with Device

Following a decade of research and investigation, Sinaptica Therapeutics has won FDA’s Breakthrough Device Designation […]

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Clinical Study FDA Neuro

NeuroOne receives US FDA 510(k) clearance to market Evo sEEG system for less-than-30-day use

NeuroOne Medical Technologies has announced that it has received US Food and Drug Administration (FDA) […]

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FDA IDE Neuro

Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

Cambridge-based Sinaptica Therapeutics, a company providing electromagnetic treatment for patients with neurodegenerative diseases, announced its […]

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FDA MedTech Patient Monitoring

GE forms pact with AMC Health to enable more remotely monitored home care

Dive Brief: GE Healthcare is partnering with AMC Health to extend its patient monitoring capabilities into the home. […]

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FDA Imaging Surgery

Vivace Ultra Nabs FDA Nod

Aesthetics Biomedical — a medical aesthetics device, product, and services company — today announced the FDA clearance […]

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FDA Healthcare MedTech

FDA launches TAP Pilot to speed access to safe and innovative medical devices

The US Food and Drug Administration announced that it has launched a pilot program designed […]

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FDA Healthcare Wearables

Plant-Based Face Masks Granted Emergency Use Authorization by FDA

Precision ADM (PADM) Medical Group of Companies has earned Emergency Use Authorization (EUA) from FDA […]

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AI FDA Neuro

Nevro announces US FDA approval of HFX iQ system to personalise chronic pain treatment

Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) […]

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FDA Implantables Spine

Life Spine announces FDA 510(k) clearance for its GHOST 3D-printed titanium spacer system

Life Spine has received clearance from the US Food and Drug Administration (FDA) to market […]

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Diagnostics FDA Neuro

Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA

Dive Brief Some types of risk-scoring tools would be regulated as medical devices, according to […]

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FDA MedTech Neuro

Phagenesis announces US launch of neurostimulation system for post-stroke swallowing control

Phagenesis today announced that the US Food and Drug Administration (FDA) has granted a de […]

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FDA Patient Monitoring Pediatrics

Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter

Dive Brief: Owlet has filed a 510(k) premarket notification for a prescription-only medical device that checks the […]

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Diagnostics FDA Women's Health

Roche wins FDA approval for companion diagnostic to support breast cancer therapy

Dive Brief: Roche has received approval from the Food and Drug Administration for the first companion diagnostic to […]

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AI Diagnostics FDA

Friday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game

As artificial intelligence makes its way into hospitals and laboratories, pathologists are starting to use […]

Topic: FDA

CAVUX facet fixation system granted FDA approval for the treatment of cervical pseudarthrosis

FDA Grants New Approval for Essential Tremor Treatment from Insightec

Abbott Snags Eterna SCS FDA Greenlight

A Medical Device FDA Clearance for the History Books

Saluda Medical initiates US commercialization of the Evoke spinal cord stimulation system

FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer

Click wins FDA breakthrough designation for prescription digital migraine therapy

TruLift lateral expandable spacer system and lateral plate system granted FDA approval

Dexcom’s G7 glucose monitor wins awaited FDA clearance

Avenda Health receives FDA clearance for AI support software for prostate cancer

ChroniSense Medical receives FDA 510(k) for RPM wearable

Imagen Technologies wins FDA nod for computer-assisted detection device

FDA clears cortical neuromonitoring strip from Wise

Swiss parliament votes to accept US FDA-approved medical devices

FDA clears mobile CT scanner from Samsung’s NeuroLogica

Avicenna.AI partners with CARPL.ai to provide AI-powered radiology solutions

Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement

AEYE Health receives FDA 510(k) for AI-backed diabetic retinopathy screening

Apple Watch app for monitoring Parkinson’s symptoms earns FDA clearance

LivaNova LifeSparc ACS pump cleared for extended use

Centinel Spine announces first commercial use of prodisc C SK cervical total disc replacement device

Accelus announces FDA clearance for Remi robotic navigation system software update

Nevro announces US FDA approval of HFX iQ system to personalize chronic pain treatment

OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price

BioIntelliSense adds skin-color sensitive pulse oximeter amid FDA concerns over fingertip devices

Sinaptica Looks to Treat Alzheimer’s Disease Symptoms with Device

NeuroOne receives US FDA 510(k) clearance to market Evo sEEG system for less-than-30-day use

Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

GE forms pact with AMC Health to enable more remotely monitored home care

Vivace Ultra Nabs FDA Nod

FDA launches TAP Pilot to speed access to safe and innovative medical devices

Plant-Based Face Masks Granted Emergency Use Authorization by FDA

Nevro announces US FDA approval of HFX iQ system to personalise chronic pain treatment

Life Spine announces FDA 510(k) clearance for its GHOST 3D-printed titanium spacer system

Software to predict risk of sepsis, stroke should be regulated as a medical device, says FDA

Phagenesis announces US launch of neurostimulation system for post-stroke swallowing control

Owlet seeks clearance of blood-oxygen-measuring baby sock after FDA warning letter

Roche wins FDA approval for companion diagnostic to support breast cancer therapy

Friday Q&A: Paige CEO Andy Moye on how digital pathology is changing the diagnostic game