Medtech company HeraMED (ASX: HMD) has seen a major spike in investor confidence after securing clearance from the US Food and Drug Administration (FDA) for HeraBEAT US – their fetal ultrasonic heart monitor.
Intended to detect, display and replay heart beats from as early as 12 weeks into pregnancy, the handheld device was developed in collaboration with the Mayo Clinic, various medical institutions and hospitals.
“Receiving FDA 510(k) clearance for the HeraBEAT US device is a tremendous achievement for HeraMED,” said HeraMED CEO and Co Founder, David Groberman.
“The device development and testing, providing substantial evidence of the safety and effectiveness of the device, has passed a challenging and rigorous period of review by FDA and is now ready for distribution throughout the United States in the coming months.”
Having lodged an application for HeraBEAT with the FDA in April 2019, approval will now enable commercialisation of the device in a market where there are approximately 4 million pregnancies annually in the United States.
Following the confirmation of FDA approval, shares in HeraMED reached a high of $0.325 per share in morning trade, a rise of 51% on the day’s previous close price of $0.215.
FDA approval of HeraBEAT US continues a flow of regulatory approvals achieved by HeraMED which is using technology and innovative uses of pregnancy data to re-shape traditional relationships between doctors and pregnant women by providing greater means for engagement during pregnancy.