MD&M East

Examining Japan's 'Device Lag'—Part 2

Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the evidence in this two-part series. Keisuke ...
Foreign Policy

Op-ed: PMDA advances regulatory science-based “rational medicine”

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Nasdaq

BioCardia Submits Request for Clinical Data Review Meeting with Japan PMDA To Discuss Approval Pathway for CardiAMP® Cell Therapy in Ischemic Heart Failure

SUNNYVALE, Calif., July 24, 2025 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [NASDAQ:BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary ...
MD&M East

Examining Japan's 'Device Lag'—Part 1

Have notoriously long review times for device regulatory approval in Japan improved in recent years? An expert on the Japanese device market analyzes the evidence in this two-part series. Keisuke ...