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Home » Topics » Regulatory » 510(k)

510(k)
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3-17-BeholdAI-red-dot.png

Behold.ai secures 510(k) for Red Dot image recognition algorithm

March 17, 2020
By Nuala Moran
LONDON – Behold.ai Ltd. has secured U.S. FDA 510(k) approval for use of its Red Dot image recognition algorithm in the automatic diagnosis of life-threatening pneumothorax (collapsed lung). The product completes the analysis immediately, sending an alert to the radiologist as soon as an X-ray is taken. “It does in 30 seconds what would normally take up to 30 minutes,” said Simon Rasalingham, CEO of London-based Behold.ai.
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Hand holding FDA blocks

FDA calls out elimination of re-review in third-party 510(k) final guidance

March 12, 2020
By Mark McCarty
Medical devices are known to be iterative, but so are FDA guidances, and the 2018 draft guidance for third-party review of 510(k) applications was the second such document in two years. The 2020 final guidance made another adjustment or two based on feedback from industry, including a specific note that the intent of the guidance is to eliminate any need for routine FDA re-review of 510(k)s reviewed by third parties.
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FDA icons

FDA wraps up CLIA-related guidances for 510(k) diagnostics

Feb. 27, 2020
By Mark McCarty
The U.S. FDA has finalized two guidances dealing with class II tests that are subject to Medicare regulations, including the so-called dual CLIA waiver guidance. The agency said it will hold an April 14, 2020, webinar to go over both guidances, allocating 90 minutes to deal with questions about the two documents.
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Bedside MRI system receives green light from the FDA

Feb. 12, 2020
By Liz Hollis
Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.
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Product image

Biointellisense scores win at FDA with the clearance of its Biosticker

Jan. 28, 2020
By Liz Hollis
Biointellisense Inc. received good news from the U.S. FDA, which gave its nod to the company’s Biosticker on-body sensor for scalable remote care. The Biosticker allows for continuous monitoring of vital signs and actionable insights, delivered to clinicians from patients in the home setting. The goal is to help in the early detection of potentially avoidable complications.
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etectRx-ID-Capsule-12-19.png

Ingestible medication tracking gets second entrant with FDA nod for Etectrx

Dec. 20, 2019
By Stacy Lawrence
Gainesville, Fla.-based startup Etectrx Inc. has secured an FDA clearance for its ingestible event marker system, the ID-Cap system. The startup is following in the footsteps of Redwood City, Calif.-based Proteus Digital Health Inc., which pioneered the category.
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etectRx-ID-Capsule-12-19.png

Ingestible medication tracking gets second entrant with FDA nod for Etectrx

Dec. 19, 2019
By Stacy Lawrence
Gainesville, Fla.-based startup Etectrx Inc. has secured an FDA clearance for its ingestible event marker system, the ID-Cap system. The startup is following in the footsteps of Redwood City, Calif.-based Proteus Digital Health Inc., which pioneered the category. The Etectrx approach, however, obviates the need for a skin-worn patch to monitor a signal from an ingestible sensor delivered with medication that’s been taken. It is the first to transmit a signal directly from within the body to a receiver that’s worn on a lanyard.
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Medtronic Device: Autoguide Stealthstation

FDA gives nod to Medtronic’s Stealth Autoguide system for cranial procedures

Dec. 18, 2019
By Liz Hollis
Dublin-based Medtronic plc reported Wednesday that the U.S. FDA has given the green light to its Stealth Autoguide system. The company said it is the first cranial robotic platform that integrates with its enabling technology portfolio to create an end-to-end procedural solution.
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Moleculight-iX-Woundcare-12-5.png

FDA gives 510(k) nod to Moleculight’s wound assessment device

Dec. 5, 2019
By Meg Bryant
Toronto-based Moleculight Inc. has received U.S. FDA 510(k) clearance for its i:X hand-held fluorescence imaging device for use in detecting bacteria in wounds at the point of care. The milestone comes a little over a year after the agency granted de novo clearance for the device in August 2018 and lends additional credence to the device’s benefits in wound evaluation and management. “The granting of our 510(k) clearance by the FDA for the i:X hand-held fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” said Anil Amlani, Moleculight’s CEO.
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FDA offers no apparent grace period for 510(k)s under safety and performance framework

Nov. 21, 2019
By Mark McCarty
The FDA’s safety and performance-based pathway for 510(k) devices promises to streamline premarket filings, and the FDA’s Jason Ryans said on a recent webinar that any changes to the related product-specific guidances would be applicable only prospectively. Ryan made no mention of a grace period for impending applications, however, suggesting that any such devices may have to be reworked or resubmitted into a more conventional premarket channel if they do not meet the new requirements.
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