Industry Insights

A proposed ASTM International standard presents methods for detecting and quantifying cleaning markers (analytes) on reusable medical devices. ASTM’s committee on medical and surgical materials and devices (F04) is developing the proposed standard. The objective of...

Royal Philips has announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 (Model 861388 and Model 861389) and HeartStart FRx (Model...

Surveyors Will Observe Additional Safety Measures, Include New Emergency Preparedness and Infection Prevention Worksheet The Accreditation Association for Ambulatory Health Care (AAAHC) is resuming onsite surveys after temporarily pausing activities during the height...

On Tuesday, June 23, 12:00 pm – 1:00 pm ET, the U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health...

Medtronic plc and Foxconn Industrial Internet announced that Foxconn has successfully completed Medtronic’s regulatory and quality requirements necessary to begin manufacturing Medtronic Puritan Bennett 560 (PB560) ventilators for Medtronic in the United States....

Recently the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) launched a new web section “Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices” to help make it easier for the public to access...