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Home » Topics » Medical Devices » Submissions and Approvals

Submissions and Approvals
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ClearanceStamp_Blue.gif

GE Healthcare Earns FDA Clearance for Surgical Imaging System

March 25, 2021
The device can also link up with other intraoperative technologies, such as navigation and robotics systems. Read More
CE mark

Fluxergy Earns CE Mark for COVID-19 Test

March 25, 2021
The Irvine, Calif.-based company has also submitted the test for FDA Emergency Use Authorization. Read More

Recovery Force Earns 510(k) Clearance for Mobility-Measurement System

March 24, 2021
The low-profile, wearable device does not use cords or hoses and is free of disruptive pump noise. Read More
emergency use authorization approved

FDA Authorizes First COVID-19 Biomarker Screening Device

March 23, 2021
The monitor is not intended to substitute for a COVID-19 diagnostic and shouldn’t be used in patients who show symptoms, the FDA said. Read More

Life Spine’s Expandable Spine Spacer Gains FDA Clearance

March 22, 2021
The device automatically locks in place when adequate correction has been achieved. Read More
CE mark

MicrosensDx Receives CE Mark for Coronavirus Test

March 22, 2021
It can be also used to detect other pathogens, including norovirus, respiratory syncytial virus and influenza. Read More
FDA clears text

XPhyto Therapeutics’ COVID-19 Test Cleared in Europe

March 22, 2021
The test is designed for use in point-of-care locations, such as airports, border checkpoints, schools, pharmacies and hospitals. Read More

FDA Clears Catalyst OrthoScience’s Reverse-Shoulder System

March 19, 2021
The single-tray system features surgeon-targeted implant positioning as well as bone- sparing implants. Read More

Updated Version of BrainTale’s White Matter Solution Cleared in Europe

March 19, 2021
It now comes with a simplified user interface, patient follow-up and management features, and an improved visualization scale. Read More
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Roche Gets CE Mark for Compact Test Analyzer

March 19, 2021
The analyzer can perform up to 870 tests per hour and run Roche’s full offering of diagnostic tests for infectious diseases, oncology and cardiology. Read More
ClearanceStamp_Blue.gif

FDA Grants First Traditional Clearance for COVID-19 Test

March 19, 2021
With the agency’s first full approval for a COVID-19 diagnostic, tests of the same type may now go through its 510(k) pathway for potential clearance. Read More

Koios Medical’s Breast Cancer Analysis Software Gets CE Mark

March 18, 2021
The software produces a “likelihood of malignancy” finding that aligns with the American College of Radiology’s BI-RADS rating scale and Europe’s five-point rating system. Read More
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