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LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod...
SANTA CLARA, Calif. – Peter Thiel is not a fan of incremental science. The high-profile venture capital investor, who invests across technology and the life...
China announced Jan. 17 which further pharmaceutical companies it will buy from under its centralized procurement program that seeks the lowest prices. The price...
For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in...
In response to the emergence of a new coronavirus seen recently in China, and now America, Novavax Inc. has initiated development of a vaccine candidate, the...
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