USA -
FDA Finalizes Guidance on Interoperable Devices

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

The guidance, first drafted in January 2016, is meant to assist manufacturers and FDA staff in identifying considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information from devices.

It also features help for companies designing and developing interoperable medical devices, and recommendations regarding information to include in device labels and premarket submissions...

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International -
Can You Help Prevent These Insulin-Delivery Errors?

New consensus-based guidelines may inspire ideas on how to curb errors. Insulin is considered a high-alert medication because it is often associated with significant patient harm when used in error. “According to a 2014 survey of pharmacists and nurses conducted by the Institute for Safe Medication Practices (ISMP), IV insulin ranked first and subcutaneous insulin ranked ninth among nearly 40 drugs and drug classes identified as high-alert medications that concerned practitioners,” Susan F. Paparella, RN, MSN, vice president, ISMP, told MD+DI . “Yet of all the high-alert medications,...

Discovery -
Boston Scientific's New Defibrillators Really Are Smarter

New clinical trial data shows the HeartLogic Diagnostic suite of sensors significantly expanded the ability of a baseline blood test to identify when patients were at an elevated risk of a heart failure event. A suite of sensors designed to make implantable defibrillators smarter received a boost of support this week in the form of a late-breaking clinical trial presentation at the Heart Failure Society of America's annual scientific meeting in Dallas. New data confirmed that Boston Scientific's HeartLogic Diagnostic, which is slated for commercial release later this year as part of a new...

USA -
FDA clears first duodenoscope with disposable distal cap

The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. “We believe the new disposable distal cap represents a major step towards lowering the risk of future infections associated with these devices,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the...

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