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Topic: FDA

article icon article
FDA Spine Therapeutics

DiscGenics receives FDA RMAT designation for IDCT for degenerative disc disease

DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine […]

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FDA Urology Women's Health

FDA clears single-use ureteroscope system from Boston Scientific

Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its LithoVue Elite single-use […]

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Drug-delivery FDA MedTech

Vero Biotech wins FDA approval for inhaled nitric oxide delivery with anesthesia in the OR

Vero Biotech announced that the FDA approved its second-generation Genosyl system for use with rebreathing […]

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Clinical Trial FDA Genomics

FDA Asks Gene Therapy Biotech to Run Clinical Trial That Might Be Impossible

One challenge of developing a drug for a disease with no approved therapies is that […]

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FDA Gastroenterology Neuro

Axonics receives US FDA approval for fourth-generation rechargeable sacral neuromodulation system

Axonics has announced that the US Food and Drug Administration has approved the company’s fourth-generation […]

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Diabetes FDA Spine

FDA approves Abbott’s spinal cord stimulation system for diabetic peripheral neuropathy

Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful […]

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Catheters FDA Neuro

CELLO II balloon guide catheter gains US FDA approval for peripheral and neurovascular indications

The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from […]

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FDA Oncology Start-Up

Aetion, FDA partner on oncology real-world data

Aetion, a startup focusing on real-world evidence in healthcare, announced a five-year research collaboration with […]

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FDA Nephrology Therapeutics

CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy […]

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Cardiology FDA Implantables

Abbott wins FDA nod for its Navitor transcatheter aortic valve implant

Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation […]

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FDA Implantables Spine

FDA clears intervertebral body fusion system from VySpine

VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral […]

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Drug-delivery FDA MedTech

FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech

Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide […]

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Clinical Trial FDA Spine

Empirical Spine completes full premarket approval submission to FDA for LimiFlex Dynamic Sagittal Tether

Empirical Spine has revealed that it has recently completed the final step in the US […]

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FDA Wearables Women's Health

Movano unveils medical-grade smart ring for women’s health

Movano Health (Nasdaq:MOVE) announced today that it unveiled its Evie smart ring designed specifically for […]

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Clinical Trial FDA Pharmaceutical

By Eliminating Requirement for Animal Testing, FDA Modernization Act Allows Faster, More Cost-effective Drug Development

Congress passed the FDA Modernization Act 2.0 last week removing the requirement to use animal […]

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FDA Patient Monitoring Spine

Roundup: Dozee, SURGLASSES get 510(k) clearances and more briefs

Dozee scores 510(k) for AI contactless sensor for RPM Indian medical device company Dozee has […]

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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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Original post by NeuroNews International

Written by: Editor

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