FDA Warns Hungarian Devicemaker for Poor Design, Process Controls April 3, 2020 The facility failed to document or investigate software-related complaints, the agency said. Read More
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
FDA Considers Reclassifying Two Hepatitis C Virus Tests April 1, 2020 If the reclassification goes through, the tests would require 510(k) clearance. 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
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