Submissions and Approvals

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

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

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

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

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

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

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

Submissions and Approvals
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GE Healthcare Earns FDA Clearance for Surgical Imaging System

Fluxergy Earns CE Mark for COVID-19 Test

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

FDA Authorizes First COVID-19 Biomarker Screening Device

Life Spine’s Expandable Spine Spacer Gains FDA Clearance

MicrosensDx Receives CE Mark for Coronavirus Test

XPhyto Therapeutics’ COVID-19 Test Cleared in Europe

FDA Clears Catalyst OrthoScience’s Reverse-Shoulder System

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

Roche Gets CE Mark for Compact Test Analyzer

FDA Grants First Traditional Clearance for COVID-19 Test

Koios Medical’s Breast Cancer Analysis Software Gets CE Mark

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