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BioWorld - Sunday, October 1, 2023
Home » Topics » Regulatory » 510(k)

510(k)
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FDA approved icons and medical professional

FDA drops three draft guidances for 510(k)s, including a predicate best practices draft

Sep. 6, 2023
By Mark McCarty
No Comments
The U.S. FDA’s concerns about the 510(k) program over the past decade-plus are practically the stuff of regulatory urban legend, but the agency has just unveiled a trio of draft guidances to address some of those concerns. Perhaps the most significant of these is a draft guidance for selection of a predicate device for a 510(k) filing, a document that may come across to industry as little more than an attempt to limit the devices that a manufacturer can recite in a 510(k) filing.
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Imeka white matter tracking

FDA clearance, reimbursement codes greet Imeka’s white matter tracking tool

Aug. 24, 2023
By David Godkin
No Comments
Imeka Solutions Inc. has received U.S. FDA 510(k) clearance for the Advanced Neuro Diagnostic Imaging system designed to provide neurologists and radiologists with vital reference information on cerebral white matter for better management of brain diseases such as Alzheimer’s. This comes on the heels of two new CPT 3 codes for quantitative brain MRI assessment which Imeka expects its clients will begin taking advantage of by January 2024.
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Cathvision gets FDA nod for AI to evaluate success of cardiac ablation

Aug. 18, 2023
By Shani Alexander
No Comments
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
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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
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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
No Comments
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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