EBR Systems (ASX:EBR) will meet with the US Food and Drug Administration on Dec. 20 to discuss the pre-market approval application for its wireless cardiac pacing device using its WiSE CRT system, according to a Friday filing with the Australian bourse.
The so-called Day-100 meeting will allow both parties to discuss the status of the company's application and see if the regulator needs any additional requirements to advance the review, the filing said.
The meeting was made possible via the device's breakthrough device designation, which allows interactive communication during the evaluation process, the filing added.
The company's shares jumped nearly 5% in recent Friday trade.
Price (AUD): $0.93, Change: $+0.04, Percent Change: +4.85%
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.