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Home » Topics » Regulatory » 510(k)

510(k)
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Lungs wireframe illustration

FDA clears Adherium’s Hailie sensor for GSK’s Ellipta inhaler

Aug. 5, 2022
By Tamra Sami
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
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Minuteful Kidney test kit box

‘If you can text, you can test’ for kidney disease

July 22, 2022
By Annette Boyle
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
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Lumos Diagnostics sees stock plummet 65% on FDA rejection of Febridx 510(k)

July 15, 2022
By Tamra Sami
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
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Laptop displaying FDA logo

FDA’s third-party 510(k) review program losing traction

July 11, 2022
By Mark McCarty
The U.S. FDA’s third-party review program for 510(k) filings has perhaps never quite lived up to expectations that this program would take a significant load off the FDA’s shoulders, and the latest quarterly report does nothing to detract from that perception.
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Smartphone on nightstand, woman sleeping in bed

FDA gives green light to Resapp’s sleep apnea 510(k) app

July 8, 2022
By Tamra Sami
The U.S. FDA has given Resapp Health Ltd. the green light for its 510(k) Sleepcheckrx app to detect moderate to severe sleep apnea in adults as a prescription-only software-as-a-medical device. The FDA cleared the app as a class II medical device. Brisbane, Australia-based Resapp submitted the 510(k) premarket notification to the FDA in November 2021 for Sleepcheckrx for at-home sleep apnea screening.
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3D illustration of heart cross section

Acutus stock jumps following expanded FDA clearance

June 28, 2022
By Catherine Longworth
Shares in Acutus Medical Inc. (NASDAQ:AFIB) are trading 50% higher after the arrhythmia management company reported the launch of an expanded suite of its Acqcross left-heart access products. The Carlsbad, Calif.-based company received an expanded U.S. FDA clearance for its Acqcross Qx system for use with Natick, Mass.-based Boston Scientific Corp.’s Watchman left atrial appendage closure (LAAC) device.
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FDA Not Approved stamp

FDA rejects Artrya’s 510(k) for its AI-enabled Salix coronary anatomy software

June 24, 2022
By Tamra Sami
The FDA has rejected Artrya Ltd.’s 510(k) application for its Salix coronary anatomy (SCA) software that analyzes heart computed tomography scans via artificial intelligence (AI) to better diagnose coronary artery disease. “The FDA has advised that the Artrya Salix product is not equivalent to the predicate device,” Artrya CEO John Barrington told BioWorld.
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Spine analysis software on desktop monitor

SMAIO obtains clearance for surgery planning software and patient-specific rods for arthrodesis

June 17, 2022
By Bernard Banga
Just three months after raising $10 million from its IPO on the Paris Euronext Growth market, SMAIO SA (Software Machines and Adaptive Implants in Orthopedics) obtained U.S. FDA 510(k) clearance for its Balance Analyzer 3D surgery planning software and for its patient-specific union rods. This spinal realignment planning software uses medical imaging of the patient’s spine in an upright static position.
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Person using Eksonr

Ekso steps up with FDA clearance for exoskeleton use in MS

June 14, 2022
By Annette Boyle
Ekso Bionics Holdings Inc. added a new indication for its robotic Eksonr exoskeleton with a U.S. FDA 510(k) clearance for use of the mobility device in patients with multiple sclerosis (MS). The green light for MS follows clearances for stroke and spinal cord rehabilitation in 2016 and acquired brain injury (ABI) in 2020.
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Child being evaluated using Earlipoint system

FDA greenlights Earlitec autism diagnostic tool

June 14, 2022
By Catherine Longworth
The U.S. FDA has granted clearance for Earlitec Diagnostics Inc.’s Earlipoint evaluation tool for the diagnosis and assessment of autism spectrum disorder (ASD) in children aged 16-30 months. The eye-tracking technology utilizes Dynamic Quantification of Social-Visual Engagement (DQSVE), which captures a child’s moment-by-moment looking behavior. The clearance was based on positive results from two studies in which more than 500 children were enrolled.
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