The U.S. Food and Drug Administration (FDA) has launched the Rare Disease Evidence Principles (RDEP) initiative,…
Category: US
US / FDA updates on medical device regulation and quality.
FDA Urges Retailers to Cease Illegal Vape Sales in New Compliance Initiative
Marty Makary, M.D., M.P.H., Commissioner of the U.S. Food and Drug Administration (FDA), has announced a…
FDA Greenlights First Drug Targeting New World Screwworm in Cattle, Offering Prevention and Treatment
The U.S. Food and Drug Administration (FDA) has granted conditional approval for Dectomax-CA1 (doramectin injection), marking…
FDA Warns About Safety Concerns with Boston Scientific Accolade Pacemakers: Early Replacement Recommended
The FDA has issued a safety communication regarding Boston Scientific’s Accolade family of pacemakers, highlighting the…
Philips Respironics Recall: Programming Errors in DreamStation Devices Highlight Patient Risks
Philips Respironics has announced the recall of certain DreamStation Auto CPAP and Auto BiPAP devices due…
Critical FDA Update: Defibrillation Lead Advisory from Boston Scientific
The FDA has issued a public update regarding Boston Scientific’s ENDOTAK RELIANCE Defibrillation leads, highlighting potential…
Critical Update for Dexcom Continuous Glucose Monitor Apps: Software Correction Addresses Missed Failure Alerts
Dexcom, Inc. has issued a correction for its Dexcom G7 Continuous Glucose Monitoring (CGM) Apps and…
Critical Recall Update: BD Alaris™ Pump Infusion Sets Expand Warning to Higher Risks
Medical technology manufacturer BD has announced an expanded voluntary recall of certain BD Alaris™ Pump Module…
FDA Alert: Tandem Diabetes Care Updates t:slim X2 Insulin Pumps Due to Potential Speaker Wiring Fault
Tandem Diabetes Care has issued an urgent correction addressing potential risks associated with certain t:slim X2…
FDA Issues Advisory: Medline Kits Potentially Contain Defective Medtronic Heart Ventilation Cannulas
The U.S. Food and Drug Administration (FDA) has released a critical early alert regarding certain Medline…