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Home » Topics » Regulatory » 510(k)

510(k)
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Moleculight i:X device

Moleculight receives FDA clearance for detection of P. aeruginosa

Sep. 23, 2021
By Annette Boyle
Clinicians may soon be able to identify wounds likely to have difficulty healing before they deteriorate thanks to the FDA’s 510(k) clearance for Moleculight Inc.’s i:X imaging device for detection of wounds containing high levels of Pseudomonas aeruginosa (PA). The point-of-care i:X visualizes fluorescence, with wounds containing elevated levels of PA glowing cyan.
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Portico, Flexnav devices

Abbott gains foothold in TAVR market with FDA approval of Portico device

Sep. 20, 2021
By Mark McCarty
Roughly a decade has passed since the FDA first approved a transcatheter aortic valve replacement (TAVR) device, but the U.S. market has proven difficult to access for more than a small number of manufacturers. Abbott Laboratories, of Abbott Park, Ill., is now a player in the market with the FDA’s approval of the Portico device, a product that was first implanted in a human subject in 2011, a clear demonstration of the difficulty of moving these devices from research and development to the market.
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Coronavirus and antibodies

FDA clears Memed’s point-of-care infectious disease test

Sep. 20, 2021
By Catherine Longworth
The U.S. FDA has cleared Memed Diagnostics Ltd.'s blood test for distinguishing between bacterial and viral infections. The diagnostic test has been tipped as an essential step in the fight against antimicrobial resistance. While most infectious disease tests look for the pathogen, Memed BV is an advanced host immune response test that measures the levels of immune system proteins and applies proprietary algorithms to generate an immune signature.
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Red dart in center of red target

FDA clearance for Renovocath delivery system sends Renovorx’s stock higher

Sep. 10, 2021
By Catherine Longworth
The share price of Renovorx Inc. has spiked following FDA clearance for its Renovocath delivery system. Since the company announced the clearance, its stock (NASDAQ:RNXT) has climbed by more than 13%. Last month the company completed an IPO for approximately $16.6 million, issuing shares at $9-$11.
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NPSIMS photo

Only positives for Aatru’s FDA-cleared negative pressure surgical management system

Sep. 2, 2021
By David Godkin
Aatru Medical LLC has received FDA 510(k) class II clearance for a platform that turns its back on electro-mechanical components in other negative pressure wound therapy (NPWT) systems. Deployed for closed surgical incision applications, the Negative Pressure Surgical Incision Management System (NPSIMS) is a single-use, disposable platform that could help reduce the 20% of hospital infections attributed to surgical site infections (SSI).
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U.S. FDA headquarters

FDA’s Rx-to-OTC policy clashes with 510(k) changes guidance

Aug. 26, 2021
By Mark McCarty
The wave of home-use tests for the COVID-19 pandemic has amplified the question of how device makers might validate such a test, but there is also the question of how to convert a device from prescription-only (Rx-only) use to over-the-counter (OTC) status to consider. The FDA has provided an update on OTC devices, which indicates that a conversion from prescription-only use to OTC use will require usability testing and a new regulatory filing, but the update conflicts with the agency’s own policy on changes to a device undertaken only to convert the label from prescription to OTC use.
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Letter blocks with the word fraud in red

FDA alleges fraud, pulls accreditation of third-party reviewer

Aug. 20, 2021
By Mark McCarty
The FDA said it has withdrawn the accreditation of Accelerated Device Approval Services LLC (ADAS), of Miami, for making false presentations about one of the company’s employees. Among the allegations are that the company named a reviewer who was never employed by ADAS, and that the company misled a client about the status of a regulatory filing.
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Patient undergoing cognitive testing with Champ

Voxneuro cognitive platform to launch following Canadian and FDA approvals

Aug. 13, 2021
By David Godkin
TORONTO – Western New York Imaging Group, a one-hour drive across the U.S.-Canadian border, will soon be the site for a hard launch of Champ, a system developed by Voxneuro Inc. that evaluates suspected cognitive brain disorder or symptoms such as fatigue, memory loss or brain fog. This comes after Voxneuro won FDA registration of the cognitive platform as a class II exempt medical license, followed last month by Health Canada approval of the system for help diagnosing concussion, traumatic brain injury and dementia.
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Spintech’s MRI enhancement technology gets FDA nod

Aug. 10, 2021
By Meg Bryant
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
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Laptop displaying FDA logo

FDA says PMA first cycle major deficiency rate approaching 21st century high

Aug. 5, 2021
By Mark McCarty
The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
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