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Home » Topics » Regulatory » 510(k)

510(k)
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Neuromark system

Rising demand spurs Neurent to open new Neuromark facility

June 18, 2025
By Shani Alexander
Amid rising demand for its Neuromark system, Neurent Medical Ltd. opened a new manufacturing facility in Ireland, which will serve as the central hub for the production of the device which treats chronic rhinitis.
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Dexcom G7 CGM

FDA clears Dexcom G7 15 Day

April 11, 2025
By Annette Boyle
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
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David Luria Ziv Menshes

Cardiovia Viaone epicardial access system secures US FDA clearance

April 11, 2025
By Shani Alexander
Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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Lunit Insight MMG

AI-enhanced mammogram readings are better, but ignored

April 10, 2025
By Marian (YoonJee) Chu
AI could significantly improve the value of patient recalls following mammography, but so far radiologists seem reluctant to rely on computer-aided readings. Radiologists tend to trust their own judgment – and that of their colleagues – in mammogram readings far more than AI-based diagnostics, even when the AI is much more accurate, a prospective trial analysis published in Radiology by Karolinska Institutet researchers found.
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Orthocell Remplir

FDA gives nod to Orthocell’s 510(k) for nerve repair product

April 9, 2025
By Tamra Sami
The U.S. FDA has cleared regenerative medicine company Orthocell Ltd.’s 510(k) for its nerve repair product, Remplir, paving the way to begin commercial operations in the $1.6 billion U.S. nerve repair market.
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Illustration of lung cancer, DNA double helix

FDA clears Gleamer, Azmed AI-powered tools for chest X-rays

April 1, 2025
By Shani Alexander
Two French startups, Gleamer SAS and Azmed SAS, received clearance from the U.S. FDA for their AI-powered tools for chest X-rays. They join an increasing number of companies developing software tools to help clinicians detect a range of abnormalities on images, enhancing diagnostic accuracy, reducing delays and improving patient outcomes.
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Roche building

​US FDA clears Roche’s preeclampsia test

Feb. 14, 2025
By Annette Boyle
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
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Hand cupping ear to illustration hearing loss

Essilorluxottica receives US, EU, green light for OTC Audio Glasses

Feb. 3, 2025
By Shani Alexander
Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.
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Inflammatix Triverity test system

Inflammatix’s Triverity scores FDA clearance for ER sepsis test

Jan. 21, 2025
By Annette Boyle
Just a few weeks later than expected, Inflammatix Inc. secured U.S. FDA clearance of the Triverity test system for use in emergency triage of patients with suspected acute infection or sepsis. The molecular blood test is the first to identify bacterial and viral infections and provide an all-cause risk evaluation of the likelihood of developing severe illness.
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Neurophet Aqua

Neurophet wins FDA nod for brain AI software, targets US expansion

Nov. 25, 2024
By Marian (YoonJee) Chu
On the heels of U.S. FDA approval for Neurophet Aqua, an updated version of its artificial intelligence (AI)-based magnetic resonance imaging analysis software for the brain, Neurophet Inc. is preparing for an IPO in 2025 and expansion into U.S. and European markets.
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