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iCardio.ai gets FDA 510(k) clearance for AI echocardiography

Posted on October 28, 2024

The algorithms are used to detect valvular heart disease.

Read the full article at: www.mobihealthnews.com

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Rapid Response Diagnostics Unveils Next-Level Auditing and Diagnostic Software for Medical Practices

Posted on

[𝐈𝐝𝐚𝐡𝐨, 𝐔𝐒𝐀] – Rapid Response Diagnostics, a division of the Beto Paredes Family of Companies, is excited to announce the launch of its advanced software platforms designed to enhance medical practices through innovative patient intake, underpayment auditing, diagnostics, and patient…

Read the full article at: web3wire.org

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The Importance of In Vitro Diagnostic Devices in Healthcare

Posted on

Detection and management of diseases are two of the most important functions that in vitro diagnostic devices provide in the rapidly developing field of healthcare. Biological samples are analyzed by these machines, which provide information that is necessary for clinical decision-writing.

Read the full article at: pi123.org

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Accure Acne Announces New FDA Clearance for the Long-Term Treatment of Acne

Posted on

/PRNewswire/ — Accure Acne, Inc.™ (www.accureacne.com), a pioneer in the development of innovative solutions for the treatment of acne, announced today that…

Read the full article at: www.prnewswire.com

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FDA Names a New Chief of Medical Devices

Posted on

Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

Read the full article at: biztoc.com

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Nvision Gains FDA Clearance for First 3D-Printed Porous PEEK Interbody System

Posted on

Nvision Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, in collaboration with Invibio Biomaterial Solutions, a global leader in high-performance biomaterials, has received FDA clearance for the first 3D-printed porous PEEK Interbody System.

Read the full article at: 3dprintingindustry.com

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Bracco Diagnostics Inc. and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI

Posted on

/PRNewswire/ — Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A, one of the world’s leading companies in the diagnostic imaging business,…

Read the full article at: www.prnewswire.com

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Natus seeks FDA 510(k) clearance for its highly anticipated point-of-care EEG solution

Posted on

/PRNewswire/ — Natus Medical Incorporated announced it has submitted an FDA 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for…

Read the full article at: www.prnewswire.com

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Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System

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/PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration…

Read the full article at: www.prnewswire.com

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Wearable Tumor-Zapping Medical Device Wins FDA Approval for Lung Cancer

Posted on

The FDA approved Novocure medical device Optune Luna as a treatment for advanced cases of non-small cell lung cancer. The wearable technology delivers electrical fields that kill cancer cells.

Read the full article at: medcitynews.com

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