US / FDA updates on medical device regulation and quality.
168 articles
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Dectomax-CA1 (doramectin injection), marking a significant milestone for…
The FDA has issued a safety communication regarding Boston Scientific’s Accolade family of pacemakers, highlighting the potential need for early…
Philips Respironics has announced the recall of certain DreamStation Auto CPAP and Auto BiPAP devices due to programming errors that…
The FDA has issued a public update regarding Boston Scientific’s ENDOTAK RELIANCE Defibrillation leads, highlighting potential risks tied to expanded…
Dexcom, Inc. has issued a correction for its Dexcom G7 Continuous Glucose Monitoring (CGM) Apps and Dexcom ONE+ CGM Apps…
Medical technology manufacturer BD has announced an expanded voluntary recall of certain BD Alaris™ Pump Module model 8100 infusion sets.…
Tandem Diabetes Care has issued an urgent correction addressing potential risks associated with certain t:slim X2 insulin pumps. Healthcare professionals,…
The U.S. Food and Drug Administration (FDA) has released a critical early alert regarding certain Medline Convenience Kits, which may…
Mo-Vis BVBA has announced an urgent firmware correction for their R-net joystick devices used in powered wheelchairs. This update responds…
The FDA issued a critical safety communication on September 16, 2025, advising against the use of unauthorized infant devices designed…
The U.S. Food and Drug Administration (FDA) has issued an important safety communication regarding blood pressure measurement devices. This announcement,…
The U.S. Food and Drug Administration (FDA) has announced a significant shift in its regulatory communication practices. Starting immediately, the…