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FDA Grants Breakthrough Device Designation for Emerging High-Intensity Focused Ultrasound Treatment of Pancreatic Cancer

FDA Grants Breakthrough Device Designation for Emerging High-Intensity Focused Ultrasound Treatment of Pancreatic Cancer | Health Device News | Scoop.it
From www.diagnosticimaging.com - October 16, 2024 7:29 AM

The Sonire Therapeutics ultrasound system is currently being studied for the treatment of patients with unresectable pancreatic cancer refractory or intolerant to first-line chemotherapy.

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December 18, 2025 4:13 PM
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Francis Medical gets FDA green light for water vapor ablation to treat prostate cancer

Francis Medical gets FDA green light for water vapor ablation to treat prostate cancer | Health Device News | Scoop.it
From www.fiercebiotech.com - December 10, 2025 9:25 AM

Francis Medical garnered a 510(k) clearance for its water vapor ablation therapy for cancers of the prostate, kidneys and bladder.

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December 18, 2025 4:08 PM
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FDA making use of real-world evidence in device applications easier (BSX:NYSE)

FDA making use of real-world evidence in device applications easier (BSX:NYSE) | Health Device News | Scoop.it
From seekingalpha.com - December 15, 2025 4:13 PM

Learn how the FDA is easing real-world evidence rules for medical devices, reducing data burdens for sponsors.

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December 18, 2025 4:04 PM
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Galway medtech SymPhysis Medical seeks FDA approval

Galway medtech SymPhysis Medical seeks FDA approval | Health Device News | Scoop.it
From www.independent.ie - December 18, 2025 12:30 AM

Galway medtech firm SymPhysis Medical is looking to complete a crowd-­funding round by the end of the year, as part of up to €5m of investment sought to help bring its key medical device to market.

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December 18, 2025 4:02 PM
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FDA Clears Ceribell’s AI-Powered EEG as First Device for Continuous Delirium Monitoring

FDA Clears Ceribell’s AI-Powered EEG as First Device for Continuous Delirium Monitoring | Health Device News | Scoop.it
From hitconsultant.net - December 12, 2025 3:16 AM

Ceribell, Inc.has secured FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring solution,...

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December 18, 2025 4:00 PM
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MMI earns FDA clearance for robotic soft tissue dissection tools

MMI earns FDA clearance for robotic soft tissue dissection tools | Health Device News | Scoop.it
From www.therobotreport.com - December 10, 2025 11:11 AM

MMI’s dissection instruments are some of the smallest fully wristed robotic instruments designed for dissection in open microsurgery.

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December 18, 2025 4:00 PM
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SS Innovations submits robotic system for FDA clearance

SS Innovations submits robotic system for FDA clearance | Health Device News | Scoop.it
From www.medtechdive.com - December 8, 2025 1:10 PM

After introducing its robot in multiple countries outside the U.S., including India, the company turns its focus to the world’s largest robotic surgery market.

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December 18, 2025 3:58 PM
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HeartBeam swells on turning FDA rejection into ECG clearance

HeartBeam swells on turning FDA rejection into ECG clearance | Health Device News | Scoop.it
From www.fiercebiotech.com - December 11, 2025 11:50 AM

The FDA's change of heart has HeartBeam planning a commercial launch in the new year for its credit card-sized ECG system.

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December 18, 2025 3:57 PM
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FDA OKs First At-Home Brain Stim Device for Depression

FDA OKs First At-Home Brain Stim Device for Depression | Health Device News | Scoop.it
From www.medscape.com - December 11, 2025 2:25 PM

The FL-100 tDCS system is available by prescription for adults with moderate to severe MDD in the current episode, either as monotherapy or as an adjunctive treatment.

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December 3, 2025 12:04 PM
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Mindray Debuts Resona A20 Premium Ultrasound Device at RSNA | Diagnostic Imaging

Mindray Debuts Resona A20 Premium Ultrasound Device at RSNA | Diagnostic Imaging | Health Device News | Scoop.it
From www.diagnosticimaging.com - December 2, 2025 9:24 AM

The Resona A20 device reportedly provides advances in imaging and AI automation along with an intuitive ergonomic design for ease of use.

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December 3, 2025 12:03 PM
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Augmedics wins FDA clearance for next-gen AR headset

Augmedics wins FDA clearance for next-gen AR headset | Health Device News | Scoop.it
From www.massdevice.com - November 12, 2025 9:21 AM

Augmedics announced today that it received FDA 510(k) clearance for X2, its next-generation augmented reality (AR) headset.

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December 3, 2025 12:01 PM
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Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing Device Hemastyl

Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing Device Hemastyl | Health Device News | Scoop.it
From www.prnewswire.com - November 13, 2025 10:39 AM

/PRNewswire/ -- Rapid Nexus Nanotech Wound Solutions, Inc., a California-based med-tech company focused on advanced wound care, today announced it has received...

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December 3, 2025 12:00 PM
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Vesalio receives two US FDA 510(k) clearances for aspiration devices

Vesalio receives two US FDA 510(k) clearances for aspiration devices | Health Device News | Scoop.it
From neuronewsinternational.com - November 19, 2025 9:00 AM

Vesalio recently announced two new US Food and Drug Administration (FDA) 510(k) clearances for its aspiration devices.

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December 3, 2025 11:58 AM
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IR Update: FDA Clears Emerging Prostate Tissue Ablation System for Intermediate Risk PCa | Diagnostic Imaging

IR Update: FDA Clears Emerging Prostate Tissue Ablation System for Intermediate Risk PCa | Diagnostic Imaging | Health Device News | Scoop.it
From www.diagnosticimaging.com - December 2, 2025 7:43 PM

Preliminary research has shown that the Vanquish Water Vapor Ablation System eliminated MRI-visible intermediate-risk PCa in over 90 percent of patients.

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December 18, 2025 4:08 PM
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Joint Preservation Innovations Announces FDA 510(k) Clearance for the Articulator™ Arthroscopic Bur — the First and Only FDA-Cleared Articulating Rotary Cutting Instrument

Joint Preservation Innovations Announces FDA 510(k) Clearance for the Articulator™ Arthroscopic Bur — the First and Only FDA-Cleared Articulating Rotary Cutting Instrument | Health Device News | Scoop.it
From ryortho.com - December 8, 2025 3:46 PM

Joint Preservation Innovations Inc. announced that FDA has granted 510(k) clearance for the Articulator™ Arthroscopic Bur.

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December 18, 2025 4:05 PM
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Atraverse Medical Secures FDA 510(k) Clearance for HOTWIRE™ RF Generator & Fully Integrated Transseptal Access System

Atraverse Medical Secures FDA 510(k) Clearance for HOTWIRE™ RF Generator & Fully Integrated Transseptal Access System | Health Device News | Scoop.it
From www.prnewswire.com - December 4, 2025 10:00 AM

/PRNewswire/ -- Atraverse Medical, a medical device company pioneering next-generation left-heart access technology, has received 510(k) clearance from the U.S....

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December 18, 2025 4:03 PM
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Cutera® Announces New FDA Clearances for truFlex® to Support Rehabilitation, Recovery and Muscle Wellness

Cutera® Announces New FDA Clearances for truFlex® to Support Rehabilitation, Recovery and Muscle Wellness | Health Device News | Scoop.it
From www.prnewswire.com - December 18, 2025 8:01 AM

/PRNewswire/ -- CUTERA, INC., a leading provider in aesthetic, dermatological solutions, today announced that the U.S. Food and Drug Administration (FDA) has...

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December 18, 2025 4:00 PM
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Bendit Announces FDA Clearance for the Bendit17™ Steerable Microcatheter

Bendit Announces FDA Clearance for the Bendit17™ Steerable Microcatheter | Health Device News | Scoop.it
From www.prnewswire.com - December 10, 2025 6:00 AM

/PRNewswire/ -- Bendit Technologies is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Bendit17™...

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December 18, 2025 4:00 PM
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Coronary thrombectomy system gains US FDA clearance

Coronary thrombectomy system gains US FDA clearance | Health Device News | Scoop.it
From cardiovascularnews.com - December 12, 2025 7:28 AM

Vesalio has announced US Food and Drug Administration (FDA) 510(k) clearance and the upcoming US commercial launch of enVast, a clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation.

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December 18, 2025 3:59 PM
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Medivis receives “world’s first” US FDA clearance for AR navigation in cranial neurosurgery

Medivis receives “world’s first” US FDA clearance for AR navigation in cranial neurosurgery | Health Device News | Scoop.it
From neuronewsinternational.com - December 17, 2025 5:17 AM

Medivis has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its cranial navigation platform, making it the “world’s first” augmented reality (AR) system cleared for intraoperative guidance in cranial neurosurgery, according to the company.

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December 18, 2025 3:57 PM
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CMR Surgical receives FDA clearance for Versius Plus surgical robot

CMR Surgical receives FDA clearance for Versius Plus surgical robot | Health Device News | Scoop.it
From www.therobotreport.com - December 18, 2025 8:14 AM

The FDA previously granted marketing authorization for CMR’s first-generation Versius Surgical System in October 2024.

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December 3, 2025 12:05 PM
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Withings Redefines At-Home Family Healthcare in the US with FDA Clearance of BeamO

Withings Redefines At-Home Family Healthcare in the US with FDA Clearance of BeamO | Health Device News | Scoop.it
From www.prnewswire.com - November 13, 2025 8:00 AM

/PRNewswire/ -- Withings, the world leader in connected health, today announced that the FDA has cleared BeamO1, the revolutionary health check-up tool. This...

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December 3, 2025 12:04 PM
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Paradromics Gets FDA Approval to Trial Its Brain Implant in People

Paradromics Gets FDA Approval to Trial Its Brain Implant in People | Health Device News | Scoop.it
From www.wired.com - November 20, 2025 8:00 AM

The Austin-based startup will test its high-bandwidth device to help restore speech in people with extremely limited movement.

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December 3, 2025 12:02 PM
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Stereotaxis nets FDA clearance for redesigned surgical robot

Stereotaxis nets FDA clearance for redesigned surgical robot | Health Device News | Scoop.it
From www.medtechdive.com - November 12, 2025 10:06 AM

The company also posted weaker third-quarter results, but CEO David Fischel said orders for the new GenesisX system, when fully launched, would outpace the rate for an older model.

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December 3, 2025 12:00 PM
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Zimmer Biomet Receives FDA Clearance For Enhanced Knee Replacement Technology –

Zimmer Biomet Receives FDA Clearance For Enhanced Knee Replacement Technology – | Health Device News | Scoop.it
From www.inkfreenews.com - November 22, 2025 8:30 AM

Warsaw-based Zimmer Biomet, a global medical technology leader, today announced U.S. Food and Drug Administration, clearance of ROSA Knee with OptimiZe, an enhanced version of its ROSA Knee System that offers a more customized experience for surgeons to help deliver accurate and reproducible...

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December 3, 2025 12:00 PM
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Meduloc Steps Into the Spotlight With FDA Clearance

Meduloc Steps Into the Spotlight With FDA Clearance | Health Device News | Scoop.it
From ryortho.com - November 19, 2025 11:00 AM

FDA just cleared a fresh option for small bone fixation which is minimally invasive, fast, stable, and more patient-friendly.

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