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The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA. Read More
The number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013. Read More
The association pointed to the upwards 200,000 computers across more than 150 countries that were victims of the WannaCry ransomware attack earlier this year. Read More
The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Read More
The FDA recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. Read More
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More
The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications. Read More
J&J, which faces more than 9,700 lawsuits over Pinnacle implants in state and federal courts across the country, said it would immediately begin the appeal process. Read More
The House Energy and Commerce Committee is giving the Department of Health and Human Services until no later than Dec. 15 to come up with an action plan for creating “bills of materials” to enhance cybersecurity for healthcare technologies. Read More