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The machine learning platform combines all the information to help clinicians understand each patient’s pharmacological profile and optimize dosing. Read More
According to the company, its Accelerate Pheno system “has been shown to deliver improvements in clinical outcomes including time to results, time to optimal therapy, duration of therapy and hospital length of stay.” Read More
The device can help reduce catheter line-associated bloodstream infections, according to Mayo Clinic anesthesiologist Gregory Schears, a clinical adviser to PuraCath. Read More
An EU expert panel has challenged a notified body’s clinical evaluation report, which is an additional element of conformity assessment for certain high-risk devices under the EU’s Medical Device Regulation (MDR), marking the first such challenge. Read More
The EU’s Medical Device Coordination Group (MDCG) has issued new advice to devicemakers on how to integrate EU unique device identification (UDI) requirements into their quality management systems. Read More
FDA investigators observed a variety of good manufacturing practice deficiencies during inspections this spring at facilities in California, Minnesota, New York, North Carolina and Texas. Read More