Biowave Hit With Form 483 Over Quality Audits, Management Review July 24, 2017 Investigators found that the facility lacked management review procedures. Read More
FDA Cites Mb Industria Cirurgica on CAPA, Training July 24, 2017 The agency issued the form following a March inspection of the firm’s facility in Paulista, Brazil. Read More
Masimo Scores CE Mark for RPVi Device July 24, 2017 The announcement comes the week after the company announced CE Mark approval for its Rainbow Super DCI-mini sensor. Read More
FDA Announces Recall for Penumbra Revascularization Device July 24, 2017 The device is indicated for revascularization of patients with acute ischemic stroke. Read More
CarboFix Lands 483 for Quality Audits, Anti-Contamination July 21, 2017 CarboFix also had no testing procedures for its implanted medical device for Endotoxin, a known contaminate, according to the FDA. Read More
Devicemaker Cited for CAPA, Other Deficiencies July 21, 2017 A March inspection of the Full Range Rehab facility in West Chester, Ohio, found the firm had no CAPA procedures. Read More
Biotronik Atrial Leadless ICD Line Scores FDA Approval July 21, 2017 The Intica device line is the first that does not require an atrial lead. Read More
FDA Clears First Neonatal MRI Device July 21, 2017 The device does not require a safety zone or radiofrequency shielded room. Read More
FDA Cites Peter Schiff on Validation Procedures, Record-Keeping July 21, 2017 The facility lacked proper device history records for some devices. Read More
MHRA Updates Guidance on UK Notified Bodies July 21, 2017 The MHRA and the European Medicines Agency are intertwined, so it will be difficult for the MHRA to make a clean break. Read More
Voluntis Secures FDA Clearance and CE Mark for Digital Diabetes Management System July 21, 2017 Voluntis plans to launch the system in the European market in the near future. Read More
Edap Withdraws 510(k) Device Application to Redo Clinical Data July 21, 2017 The revised application will stay the same beyond the updated data. Read More