Galien Foundation chooses 10 most innovative medical devices of 2018
Editor's Note Nominees for the Best Medical Technology of 2018 were recently chosen by The Galien Foundation, the August 6 Medical Design & Outsourcing reports. Among the 10 most innovative medical devices are: Boston Scientific’s Axios stent and electrocautery enhanced delivery system Boston Scientific’s SpyGlass direct visualization system for cholangiopancreatoscopy…
FDA: Class I recall of Arkon Anesthesia Delivery System
Editor's Note The Food & Drug Administration on August 10 identified the recall of Spacelabs Healthcare’s (Snoqualmie, Washington) Arkon Anesthesia Delivery System as Class I, the most serious. The recall was issued because of the system going into a “failed state,” during which the mechanical ventilation function stops working. This…
FDA issues warning on azithromycin
Editor's Note The Food and Drug Administration (FDA) on August 3 issued a warning for azithromycin, saying the antibiotic should not be given long-term to prevent an inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. A clinical trial…
FDA issues update on wearable cardioverter defibrillator
Editor's Note The Food and Drug Administration (FDA) on July 25 issued an update for the Zoll LifeVest 4000 wearable cardioverter defibrillator. The update provides information on efforts by Zoll to remedy the potential hazard of the device failing to deliver a life-saving shock if not replaced soon after displaying…
FDA finalizes guidance for use of EHR data in clinical studies
Editor's Note The Food and Drug Administration (FDA) on July 19 finalized its guidance for using electronic health record (EHR) data in FDA-regulated clinical studies. The guidance is meant to encourage the use of EHR data in clinical studies and promote greater interoperability between EHR and electronic data capture systems.…
FDA statement on access to opioids for patients with chronic, end-of-life pain
Editor's Note Food & Drug Administration (FDA) commissioner, Scott Gottlieb, MD, on July 9 issued a statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with the need to stem the misuse and abuse of opioids. As the FDA considers new steps to address the…
FDA requires new labeling for fluoroquinolone antibiotics
Editor's Note The Food & Drug Administration announced on July 10 that it was requiring labeling changes for fluoroquinolone antibiotics because they may cause significant decreases in blood sugar and mental health side effects. The labels will add that low blood sugar levels can lead to coma and make the…
FDA: US will no longer perform Zika tests on individual blood donations
Editor's Note The Food & Drug Administration (FDA) on July 6 announced that individual blood donations no longer need to be screened for Zika virus, “unless there is an increased risk of local mosquito-borne transmission of Zika virus in a specific geographic area that would trigger individual donation testing in…
FDA letter updates risks of Type III endoleaks with aortic endovascular graft systems
Editor's Note In a June 19 letter to healthcare providers, the Food & Drug Administration (FDA) says it continues to evaluate information from several sources, including manufacturers, on the risks associated with Type III endoleaks with various endovascular graft systems used for treatment of abdominal aortic aneurysms (AAAs) and aorto-iliac…
FDA issues Safety Alert for compounded drugs containing triamcinolone, moxifloxacin
Editor's Note The Food & Drug Administration (FDA) on June 14 issued a Safety Alert for compounded drugs containing triamcinolone and moxifloxacin by Guardian Pharmacy Services (Dallas, Texas). At least 43 patients have reported adverse events after receiving eye injections of the compounded triamcinolone and moxifloxacin drug during cataract surgery.…
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