A roundup of recent medtech strategic alliances, mergers & acquisitions and financings.
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Peter Marks says labeling for CSL’s hemophilia B treatment adequately conveys its risks. He also denies NHF request that the label cite eligibility criteria used in clinical trials, responding to a citizen petition on the day the agency approves the therapy.
David Gaugh, AAM’s executive VP of sciences and regulatory affairs, was named the interim CEO, making him the fourth person to run the association since February 2020.
As Japan's PMDA reopens discussions on the appropriate regulation of AI in healthcare, a process which has so far focused on diagnostic technologies, some committee members point out the need for a more flexible approach.