Harmonizing Device CGMP Requirements with International Standards
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Hematology Testing Solution Company Earns Key Grant
YOKNEAM ILLIT, ISRAEL — PixCell Medical, innovator of rapid hematology testing solutions at the point-of-care, announced on Feb. 22 that it has been awarded a grant by the International Health-Tech Pilot Program. PixCell will utilize this grant to develop and validate...
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
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Recent Case Highlights Importance of Where Whistleblowers Get Info
What happens when a whistleblower’s case is based on information that’s already been publicly disclosed?
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EC Agrees to Phase in New IV Diagnostic Regulation, Starting in May
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