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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France -
La HAS échange avec les fabricants de dispositifs médicaux pour faciliter l’accès des patients à l’innovation utile

La Haute Autorité de Santé organise ce 24 novembre une journée d’échanges avec les fabricants de dispositifs médicaux. Objectif : expliciter les principes d’évaluation de la commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) afin d’accélérer l’accès des patients et des personnes en situation de handicap à l’innovation utile. À cette occasion, plusieurs documents sont publiés. La commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS), commission spécialisée de la HAS, organise une journée d’échanges...

International -
Medtronic Weathered Disasters by Bending, Not Breaking

Just like a palm tree stands its ground through the most devastating of storms, Medtronic's resiliency shined through after a quarter filled with natural disasters. Medtronic's revenue and earnings per share beat analyst expectations in the fiscal 2018 second quarter, despite getting hit with multiple natural disasters. The company delivered 3% comparable constant currency revenue growth during the quarter, CEO Omar Ishrak said during the company's earnings call. "These financial results are very encouraging when considered in the context of a quarter in which we faced three hurricanes and...

USA -
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients

The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient’s vision. Following cataract surgery, during which the natural lens of the eye that has become cloudy is removed and replaced with an artificial lens (intraocular lens, or IOL), many patients have...

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