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Home » Topics » Regulatory » 510(k)

510(k)
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U.S. FDA headquarters

Spring-loaded: BD poised to jump on pent up demand for updated Alaris following long-awaited FDA clearance

July 24, 2023
By Annette Boyle
A more than three-year commercial hold built up an estimated $1 billion in demand for Becton, Dickinson and Co.’s (BD) Alaris infusion system and BD has every intention of meeting that demand as quickly as possible now that it has FDA clearance for the updated device. The clearance allows the company to resume commercial sales and undertake remediation of its installed base of point-of-care units with enhanced features for its pumps and monitoring systems as well as new software and upgraded cybersecurity and interoperability.
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Inovedis gets FDA greenlight for rotator cuff repair system

July 14, 2023
By Shani Alexander
Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
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Sonic DL imaging vs. conventional

FDA clears GE’s AI-powered Sonic DL for faster MRI

June 9, 2023
By Meg Bryant
GE Healthcare Technologies Inc. has launched Sonic DL, a deep learning technology designed to significantly accelerate magnetic resonance imaging (MRI) exams, after receiving regulatory clearance from the U.S. FDA.
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Smartphone displaying Stethophone app

Sparrow’s smartphone stethoscope gets FDA nod

June 7, 2023
By Meg Bryant
The U.S. FDA has given the greenlight to Sparrow Acoustics Inc. (dba Sparrow Bioacoustics) for its Stethophone, a software-based technology that allows doctors and nurses to check a patient’s heart and lung sounds using a smartphone. Providers simply hold the smartphone against the patient’s chest to listen for possible abnormalities.
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Patient using Prism for PTSD along with Prism's interactive audiovisual interface.

Graymatters Health gets FDA clearance for digital therapy for PTSD

March 29, 2023
By Shani Alexander
The U.S. FDA granted Graymatters Health Ltd. 510(k) clearance to market Prism for PTSD, a non-invasive, self-neuromodulation adjunct digital therapy for post-traumatic stress disorder (PTSD).
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Enhanced MRI imaging using Prostatid.

Bot Image’s AI scores an FDA hat trick with clearance to diagnose, detect and monitor prostate cancer

March 28, 2023
By Annette Boyle
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
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Elekta Unity software on computer screen

FDA clears major upgrade to Elekta’s MR-Linac system

March 17, 2023
By David Godkin
Elekta AB received U.S. FDA clearance for what it called a “groundbreaking upgrade” of its MR-Linac platform which can continuously calculate the movement of a tumor anywhere in the body. The company said the Elekta Unity’s comprehensive motion management platform provides clinicians with enhanced, adaptive radiation therapy workflow to track moving organs such as the prostate, liver and pancreas.
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Hemosonics Quantra hemostasis system and Qstat cartridge Hemosonics Quantra hemostasis system and Qstat cartridge

Next generation, point-of-care hemostasis system gets FDA nod

Dec. 30, 2022
By David Godkin
Hemosonics LLC said it was recently awarded U.S. FDA clearance for a new hemostasis test cartridge assay it said significantly expands the indications for clinical use of its existing Quantra system to now also include trauma and liver transplantation procedures. The expanded Quantra hemostasis system with its QStat cartridge will add to capabilities of the system’s QPlus cartridge assay already established in the point-of-care and lab-based, whole blood hemostasis testing market.
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Omnipod 5, Dexcom G6 devices with mobile app on smartphone

FDA clears Insulet’s Omnipod 5 tubeless ‘artificial pancreas’ for children as young as 2

Aug. 26, 2022
By Meg Bryant
Insulet Corp. got the U.S. FDA’s nod to extend use of its Omnipod 5 automated insulin pump to children aged 2 years and up with type 1 diabetes. The expanded indication, just seven months after FDA cleared Omnipod 5 for patients 6 years and older, represents the first time a tubeless automated insulin delivery (AID) system has been authorized for use in children this young.
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Man undergoing MRI scan for prostate cancer diagnosis

FDA advances AI-enhanced tech for prostate diagnosis and treatment

Aug. 9, 2022
By Annette Boyle
Recent U.S. FDA actions could transform decades of prostate cancer care. Two companies focused on prostate cancer received good news from the FDA for their artificial intelligence (AI)-driven software. Bot Image Inc. gained FDA clearance for its medical device computer-aided detection and diagnostic tool, Prostatid. The agency also provided FDA investigational device exemption for Avenda Health Inc.’s Focalpoint ablation system that enables more accurate mapping of a patient’s prostate cancer for better surgical results.
Read More
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