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FDA grants 510(k) clearance for J&J MedTech’s Monarch Quest
The US Food and Drug Administration (FDA) has granted 510(k) clearance for Johnson & Johnson (J&J) MedTech’s Monarch Quest ...
Perfuze Receives FDA 510(k) Clearance for Zipline™ Access Catheters and Secures €22M in Additional Funding
Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA ...
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
Submission for New Intended Use That Leverages Company’s Patented OneRF® Technology Platform Expected in May 2025 EDEN PRAIRIE, Minn., March 11, ...
Perfuze Receives FDA 510(k) Clearance for Zipline Access Catheters and Secures €22M in Additional Funding
Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA ...
Morningstar2d
Growing Market Applications, Centerline Biomedical Granted FDA 510(k) Clearance for IOPS® with New, Expanded Indication for Use
The company recently received expanded applications 510(k) clearance from the US FDA for use in the peripheral, aortic and aortic side branch vasculature. The company continues investment in ...
F.A.S.T.® aiCockpit® CT Lung Nodule Software Receives FDA 510(k) Clearance
Provides Efficient Interaction with Consolidated AI ResultsPALO ALTO, Calif., March 03, 2025 (GLOBE NEWSWIRE) -- Fovia Ai, ...
Morningstar3d
NeuroOne® Accelerates Timeline of 510(k) Submission to FDA for the OneRF® Trigeminal Nerve Ablation System to Treat Facial Pain
“Building on the success of our three product families that have already achieved 510(k) FDA clearance, we have accelerated our submission timeline for the OneRF Trigeminal Nerve Ablation ...
Pharmabiz1d
Caristo Diagnostics’ CaRi-Plaque technology, an AI-assisted image analysis application to aid the diagnosis of CAD receives US FDA 510(k) clearance
Stamford, Connecticut Wednesday, March 12, 2025, 15:00 Hrs [IST] ...
PharmiWeb28d
Navigating FDA 510(k) Approval with Proregulations' Services
510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness ...