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Home » Topics » Regulatory » 510(k)

510(k)
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Knee implant in skeleton model

FDA greenlights Engage Surgical’s cementless partial knee system

July 1, 2020
By Meg Bryant
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.
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Man wearing Eksonr during therapy

Ekso's robotic exoskeleton gets FDA nod for use with ABI patients

June 25, 2020
By Liz Hollis
Ekso Bionics Holdings Inc. has received a green light from the U.S. FDA to market its Eksonr robotic exoskeleton for use with patients with acquired brain injury (ABI). The company said it is the first exoskeleton product to receive the agency's nod for rehabilitation use with ABI, allowing a broader patient population to access the device. This is good news for Richmond, Calif.-based Ekso, which, like many other device companies, saw its earnings off during the first quarter.
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Syringe with Osteo3 Zp putty and packaging

Sirakoss scores FDA nod for nanoparticle synthetic bone graft substitute

June 18, 2020
By Nuala Moran
LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo3 Zp putty consists of the granules suspended in a fully synthetic resorbable carrier.
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FDA icons

U.S. FDA encouraging COVID-19 test developers to file 510(k)s

May 27, 2020
By Mark McCarty
The number of tests of various types for the SARS-CoV-2 virus are still growing, but the emergency use authorization (EUA) program is not the only option for developers. Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiology, said on the agency’s May 27 town hall that the agency would like to see test developers file for a 510(k) for their tests when the data are sufficient to support an application, adding that any such clearances will not affect the U.S. FDA’s interest in keeping plenty of similar tests on the market via the EUA mechanism.
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Orthocell CEO with employees in the lab

Australia’s Orthocell submits 510(k) for Celgro regenerative collagen medical device

May 22, 2020
By Tamra Sami
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.
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4-2-Outset-Medical-tablo.png

FDA greenlights Outset Medical’s Tablo for home dialysis

April 2, 2020
By Meg Bryant
With the COVID-19 pandemic overwhelming hospitals and treatment centers, San Jose, Calif.-based Outset Medical Inc. scored a big win with U.S. FDA clearance of its Tablo hemodialysis system for home dialysis use. The company will begin rolling the system out for home patients in the coming months, balancing that program with demand for onsite devices to support an upswell in COVID-driven dialysis treatments.
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ABM-respiratory-biwaze-cough-system.png

FDA nod for ABM Respiratory Care’s Biwaze Cough system

April 1, 2020
By Meg Bryant
Charleston, S.C.-based startup ABM Respiratory Care has received U.S. FDA clearance for its first product, an airway clearance system known as Biwaze Cough. The portable device helps to remove secretions for people who are unable to cough or clear away secretions effectively on their own due to injury or disease.
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3-31-Siemens-RAPIDPoint-500e.png

FDA gives nod to Siemens Healthineers’ Rapidpoint 500e blood gas analyzer

March 31, 2020
By Meg Bryant
Erlangen, Germany-based Siemens Healthineers AG has secured U.S. FDA clearance for its Rapidpoint 500e blood gas analyzer. Available in CE mark countries since August 2019, the device is used to monitor respiratory distress in critically ill patients, such as those in acute care due to COVID-19.
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3-27-Pear-Somryst.png

FDA authorizes Pear Therapeutics' prescription digital insomnia therapy

March 27, 2020
By Annette Boyle
Pear Therapeutics Inc. obtained FDA approval for Somryst, the first prescription digital therapeutic for chronic insomnia. The app provides structured cognitive behavior therapy (CBT) with clinical dashboards for physicians. While CBT is the recommended first-line therapy for insomnia, the U.S. has only 500 therapists certified to provide CBT for insomnia (CBTi) for the estimated 30 million Americans who suffer from chronic difficulty going to and staying asleep.
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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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