HeraMED scores major boost in the US market, following a landmark FDA ruling
Health & Biotech
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Special Report: The FDA decision is evidence of the rapid growth in demand for market-leading telehealth solutions, in the wake of the COVID-19 pandemic
Telehealth platform HeraMED (ASX:HMD) is poised to benefit from a significant new ruling by US health regulators.
The US Food and Drug Administration (FDA) has released updated guidance concerning the use of non-invasive foetal and maternal monitoring devices.
The new rules clarify that patients can now be instructed to use remote monitoring solutions, as prescribed by a healthcare professional.
And it opens up a material market opportunity for HeraMED’s core product offering, the HeraBEAT foetal heart-rate monitor, which has already received clearance from the FDA for prescription use by medical professionals.
Having already laid the groundwork for its US entry strategy, HeraMED now has the backing – from both a product and regulatory standpoint – to engage in direct sales across the world’s largest consumer marketplace.
Importantly, the FDA ruling is a direct by-product of the broader response to the COVID-19 pandemic.
The health crisis has proven to be a significant catalyst for the recognition of the value provided by leading telehealth solutions.
Approval for off-site monitoring solutions such as HeraBEAT “may increase access to important prenatal data without the need for in-clinic visits”, the FDA said.
The technology also helps to “facilitate patient management by health care providers, while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency.”
With a market-leading product that’s already been approved for medical use, HeraMED is now perfectly positioned to benefit from the latest FDA ruling.
CEO David Groberman called the decision a “groundbreaking landmark”, in which the FDA directly “acknowledged the potential benefits of digital health and remote monitoring solutions in foetal and maternal medicine”.
Looking ahead, HeraMED now has the policy certainty to engage with healthcare clinics distribution partners across the US market.
The company is now in a “strong position to deliver commercial progress during the COVID-19 period and beyond”, ahead of the launch of its fully integrated HeraCARE platform later this year.
“We believe that HeraMED has a significant opportunity to further roll-out our remote monitoring and comprehensive digital health solution and satisfy the rapidly increasing US and global demand,” Groberman said.