HeraMED’s (ASX:HMD) foetal ultrasound heart rate monitor has got its long awaited green light to enter the US market and it has doubled in just a few days.

The US Food and Drug Administration has approved its 510(k) application meaning it can now be sold in America. The device, HeraBEAT, is an ultra-sound device that can be utilised via users’ smart phones.

Pic: HeraMED

CEO David Groberman labelled FDA clearance as a “tremendous achievement” and said the device was ready to be distributed in America in the months ahead. He noted there were four million pregnancies annually in the US.

Other med tech company executives, such as Andreas Fouras from 4Dx (which is seeking ASX listing next year), have told Stockhead the US is the hardest market to gain clearance to enter. But he also said he thought if a device could pass the US regulatory hurdles, it could make it before any regulator.

Stockhead has contacted HeraMED for further comment.

Shares gained 37 per cent this morning and have now doubled in the last week. The company blamed Thursday’s spike on a Next Tech article accidentally stating the company’s market cap as $13 billion.

The company is also working on a device, EchoBEAT, which can detect and analyse foetal movements in conjunction with heart rates.

Read More: 

Dr Boreham’s Crucible: Expectations are high as HeraMed waits to pop in the US

HeraMED shares shot higher, and it may have been due to a ‘$13 billion’ typo

In other ASX small cap health news today…

Asthma medication sensor maker Adherium (ASX:ADR) is collaborating with British social enterprise, Patient Knows Best, to support NHS commercialisation. Patients Knows best aggregates NHS data and provides patients with a full view of their health record. According to Adherium, 4 million Britons use Patient Knows Best. The partnership will mean this record will include data from Adherium’s Hailie sensors.

Prescient Therapeutics (ASX:PTX) is entering a collaboration with private stem cell therapy company Carina Biotech to develop cell therapies for cancer patients. Carina’s approach is Chimeric Antigen Receptor T cell (CAR-T cell) therapy which utilises patients’ own immune systems. Prescient CEO Steven Yatomi-Clarke said this was an exciting new frontier for the company.