Tagged FDA

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FDA releases guidance for digital health software

In response to the increasing adoption of wellness apps and health technologies, the FDA has released new guidance for the development of digital health tools. The FDA has released two draft guidance and one final guidance that highlights how the agency will approach digital health. The FDA has been making steady progress into the regulation…

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How secure are your connected devices? Arxan tells us

This year both the healthcare industry and the medical device sector have been shaken by cyber-attacks and warnings of cyber-security vulnerabilities. From WannaCry affecting the operations of NHS services to implanted devices containing vulnerabilities that could potentially lead to patient harm, the industries have been made aware of the dangers of a lack of cyber-security….

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Remote programming for cochlear implants approved by FDA

The FDA has approved a remote programming system for patients with cochlear implants, removing the need for patients to visit specialised clinics to have their devices adjusted. The programming feature is for patients who have had their cochlear implant for more than six months and are comfortable with the programming process. The remote programming session…

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Digital Health Age: Weekly news roundup

Digital Health Age takes a look at some of the biggest stories that have emerged over the course of the past week.   Ready for take-off The FDA has announced the companies that will be participating in its digital health pilot, designed to help speed up market to healthcare software. The company has chosen companies…

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FDA selects companies for digital health pilot programme

Nine companies have been selected to participate in the FDA’s digital health software precertification pilot (FDA Pre-cert), to help advance digital health regulation in the US. During his keynote address at the AdvaMed MedTech Conference, FDA commissioner Scott Gottlieb announced which companies would be taking part in the pilot. He said: “Our method for regulating…

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