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The Fitbit devices will motivate participants to “adopt healthier habits and achieve better outcomes in the areas of physical activity, sleep, nutrition and emotional wellbeing,” the company said. Read More
Manufacturers and regulators have an obligation to ensure that device benefits, risks and uncertainty are communicated in an understandable way,” the consortium said. Read More
France’s National Agency for Safety of Medicines and Health Products released new cybersecurity recommendations for medical devices designed to minimize the risk of cyber attacks. Read More
Certain models of Medtronic’s MiniMed insulin pumps have potential cybersecurity risks and should be swapped out for newer models, the FDA advised. Read More
Most comments on the FDA’s draft guidance for reclassifying surgical staplers supported the move to reclassify devices from Class I to Class II but some cautioned that the rule could adversely affect access to the products. Read More
With only nine months to go before the EU’s Medical Device Regulation hits its May 26 application date, the U.S. is pressing the EU to delay implementation for another three years. Read More