Orthocell Limited has reported a third consecutive quarter of record revenue, driven by strong sales growth and strategic market expansions, including a key US FDA submission for its nerve repair product Remplir™.
EBR Systems has announced a rescheduling of the FDA Pre-Approval Inspection for its wireless cardiac pacing device to January 14, 2025, while maintaining its regulatory approval timeline for Q1 2025 and a commercial launch later in the year.
EBR Systems Inc. has responded to ASX's price query, denying any undisclosed information behind recent trading spikes and confirming compliance with listing rules. The company also flagged an upcoming FDA inspection announcement.