Submissions and Approvals

ABM Respiratory Care’s Cough Therapy Device Cleared by FDA

April 3, 2020

The system breaks up thick secretions in the lungs. Read More

FDA Clears Sectra’s Digital Imaging Module

April 3, 2020

The module enables pathologists to review current and historical images and related data. Read More

ElectroCore Seeks EUA for Vagus Nerve Stimulation Therapy

April 3, 2020

The device is cleared in the U.S. for treating acute pain associated with migraines Read More

Tissium Receives CE Mark for Sterile Surgical Sealant

April 2, 2020

The device is indicated for use as an adjunct to sutures in vascular reconstruction. Read More

Wontech Gets FDA Clearance for Laser Device

April 2, 2020

The laser features a skin-cooling spray feature that reduces patient discomfort from pain, swelling and redness. Read More

Bodysphere Backtracks on Emergency Use Authorization for COVID-19 Diagnostic

April 2, 2020

The company’s CEO said the confusion about the authorization does not invalidate the test kit’s effectiveness. Read More

FDA Clears First Coronavirus Antibody Test for Use During Pandemic

April 2, 2020

The diagnostic can only be run in laboratories deemed capable of performing moderate and high complexity tests, the agency said. Read More

OncoSil’s Pancreatic Cancer Treatment Gets CE Mark

April 1, 2020

The device also received the FDA’s breakthrough device designation. Read More

Siemens Healthineers Earns FDA Clearance for Blood Gas Analyzer

April 1, 2020

The device is now available in the U.S. Read More

Qiagen’s COVID-19 Test Gets Emergency Use Authorization

April 1, 2020

The test produces results in about an hour. Read More

Gramercy Extremity Earns 510(k) Clearance for Fusion Plating System

March 31, 2020

GEO expects to make the system commercially available by the Summer of 2020. Read More

Genetic Signatures Seeks CE Mark for Coronavirus Diagnostic

March 31, 2020

Genetic Signatures said that running the assay on its fastest instruments can produce results for up to 188 patient samples in approximately 4.5 hours. Read More

Submissions and Approvals
RSS

ABM Respiratory Care’s Cough Therapy Device Cleared by FDA

FDA Clears Sectra’s Digital Imaging Module

ElectroCore Seeks EUA for Vagus Nerve Stimulation Therapy

Tissium Receives CE Mark for Sterile Surgical Sealant

Wontech Gets FDA Clearance for Laser Device

Bodysphere Backtracks on Emergency Use Authorization for COVID-19 Diagnostic

FDA Clears First Coronavirus Antibody Test for Use During Pandemic

OncoSil’s Pancreatic Cancer Treatment Gets CE Mark

Siemens Healthineers Earns FDA Clearance for Blood Gas Analyzer

Qiagen’s COVID-19 Test Gets Emergency Use Authorization

Gramercy Extremity Earns 510(k) Clearance for Fusion Plating System

Genetic Signatures Seeks CE Mark for Coronavirus Diagnostic

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