Industry Focus Areas, Medical, Regulations
July 6, 2021
Via: MedTech DiveHTA bodies are best known for their assessments of the value of new medicines, which can lead to countries choosing not to pay for approved products. Some of the bodies also play a role in assessing the value of new […]
June 28, 2021
Via: MedTech DiveAbbott is betting that frequent rapid COVID-19 testing at work, school and home are critical to enabling European economies to fully reopen and to allow daily life activities to resume. With CE mark approval for the direct-to-consumer Panbio, the diagnostics […]
Industry Focus Areas, Medical, Regulations
March 15, 2021
Via: MedTech DiveTo say that 2020 was a challenging year for FDA would be an understatement. The COVID-19 pandemic stretched resources thin as it grappled with unprecedented regulatory demands as a result of the U.S. public health emergency. FDA’s response to the […]
September 20, 2018
Via: Mass DeviceThe FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular […]
Design & Planning, Industry Focus Areas, Medical, Process
February 2, 2018
Via: Mass DeviceUS FDA Commissioner Scott Gottlieb provided some key digital health initiatives along with his vision on how he wants the agency to work with the sector in the coming years. A published list of the commissioner’s priorities titled “Healthy Innovation, […]
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