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

Read the full article at: www.fiercebiotech.com

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

Read the full article at: seekingalpha.com

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.

Read the full article at: www.independent.ie

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

Read the full article at: hitconsultant.net

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

Read the full article at: www.therobotreport.com

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.

Read the full article at: www.medtechdive.com

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

Read the full article at: www.fiercebiotech.com

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.

Read the full article at: www.medscape.com

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

Read the full article at: www.diagnosticimaging.com

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

Read the full article at: www.massdevice.com

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

Read the full article at: www.prnewswire.com

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

Read the full article at: neuronewsinternational.com

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

Read the full article at: www.diagnosticimaging.com

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

Read the full article at: ryortho.com

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

Read the full article at: www.prnewswire.com

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

Read the full article at: www.prnewswire.com

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

Read the full article at: www.prnewswire.com

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.

Read the full article at: cardiovascularnews.com

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.

Read the full article at: neuronewsinternational.com

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

Read the full article at: www.therobotreport.com

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

Read the full article at: www.wired.com

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.

Read the full article at: www.medtechdive.com

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...

Read the full article at: www.inkfreenews.com

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

Read the full article at: ryortho.com