HeraMED receives FDA clearance for HeraBEAT
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Medical technology company, HeraMED Limited’s (ASX:HMD) 510(k) application (K191110) for the company’s HeraBEAT US foetal ultrasonic heart rate monitor (HeraBEAT US) has been cleared by the US Food and Drug Administration (FDA).
The FDA evaluates a wide range of items for medical use, including drugs and medical devices.
The pre-market review process for the HeraBEAT US device commenced in late April 2019 and included a rigorous review by FDA of HeraMED’s comprehensive testing of the HeraBEAT US device.
Receiving the 510(k) clearance for the HeraBEAT US device allows that product to be commercially distributed throughout the United States.
Given that FDA clearance will enable HeraMED to progress its entry into the US market, this represents one of the most significant milestones in what has been a memorable maiden year for the Company.
Importantly, HeraMED already has established relationships in the US, most notably with the globally recognised Mayo Clinic, its current clinical, research and development collaborator.
Key points in FDA clearance
Working through the FDA clearance, the intended focus is for HeraBEAT US to detect foetal heart beats, display foetal heart rate, and play the foetal heart sound.
Further, HeraBEAT US is indicated for use by medical professionals in clinical or home care settings for singleton pregnancies from 12 weeks gestation.
In terms of componentry, the handheld HeraBEAT US device incorporates an ultrasound transducer, rechargeable battery, and internal microcontroller and Bluetooth Low Energy (BLE) chip for wireless data transfer from the HeraBEAT US device to the user’s smartphone.
The device offers several advantages, including a portable Ultrasound Doppler device that makes it reliable, safe to use and proven, whilst amplifying its accuracy and efficiency.
The HeraBEAT US application can be downloaded from an app store to the user's smartphone.
The HeraBEAT US application is used to communicate with the HeraBEAT US device using wireless BLE.
It controls the operation of the device and receives the FHR values for numerical display to the user while also playing the FHR sound and storing the FHR values in a history log.
All of these attributes assist expecting mothers in monitoring their pregnancies in a user-friendly manner.
HeraMED is revolutionising the pregnancy experience by empowering personalised, continuous and proactive home monitoring, to deliver better care at a lower cost.
Keeping pregnant mothers engaged, informed and well-supported provides reassurance and peace of mind while allowing the healthcare providers to work at their highest levels of ability and enabling early detection of potential risks.
Mayo Clinic and HMD will lead the digital transformation of prenatal care
HeraMED will progress the device’s entry into the US market, as quickly as practicable.
To expedite this process, management will liaise with its current clinical and research and development collaborator the Mayo Clinic, as well as other medical institutions, hospitals and medical professionals to drive growth and product uptake.
The United States represents a potentially large and addressable market for the HeraBEAT US device, in which approximately four million pregnancies occur annually.
HeraMED is confident that the HeraMED device will be well received in that market.
Discussing the significance of this development, chief executive and co-founder Mr. David Groberman said, “Receiving FDA 510(k) clearance for the HeraBEAT US device is a tremendous achievement for HeraMED.
‘’The device development and testing which has provided substantial evidence of the safety and effectiveness of the device has passed a challenging and rigorous period of review by the FDA and it is now ready for distribution throughout the United States in the coming months.
‘’Management will liaise with its in country partners, to ensure that process is as streamlined as possible.”
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