The Singapore Health Services Authority has approved the commercialization of an AI-enabled implantable cardiac device by Hydrix Medical, the medical technology business of the ASX-listed company Hydrix.
WHAT HE DOES
The device called Guardian is an implanted heart monitor similar to a single-chamber pacemaker. Unlike a pacemaker, this device monitors the heart’s electrical signal around the clock and vibrates to alert users when it detects heart rhythm abnormalities. It can detect potential cardiac events in asymptomatic people and patients with atypical symptoms.
In addition to vibrating, the Guardian also communicates with a pager-sized device that beeps and flashes to let its user know when to call a doctor or ambulance.
The heart monitor was developed by US-based Angel Medical Systems, which granted Hydrix an executive license to distribute the device in major Asia-Pacific markets.
WHY IS IT IMPORTANT
In 2020, Singapore registered about 11,500 cases of heart attacks, an average of 31 cases per day. Among them, almost a tenth died in less than a month. Meanwhile, comprehensive cardiovascular disease cost nearly one in three Singaporeans last year, according to the Singapore Heart Foundation.
Hydrix Medical says heart attacks are difficult to self-diagnose with “symptoms sometimes missed, overlooked, or even undetected.” Its Guardian heart monitor relieves users of their worries by using AI to detect an impending heart attack.
THE GREAT TREND
Prior to HSA approval, the device was used by Singaporean surgeons seeking individual special access arrangements. Since August 2020, eight Guardian implants have been performed in Singapore. The company is also working with an unnamed cardiology group in Australia to initially use the implantable monitor under a special access agreement with the Therapeutic Goods Administration.
This clearance is the latest in a series of regulatory approvals Hydrix Medical has received for the implantable heart monitor since last year. The device has already been cleared in the United States, Malaysia and New Zealand and is pending clearance in Australia and Thailand. The company is also working to seek approval in Japan, Hong Kong, and Indonesia.
Non-invasive devices are latest in heart rate monitoring. An example in Asia-Pacific is CardieX’s dual blood pressure and blood health monitor featuring its SphygmoCor technology. The company recently applied for 510(k) clearance from the US FDA for the device, which measures central blood pressure to detect several indicators of arterial health, such as arterial stiffness and pulse pressures.
Another is Samsung Advanced Institute of Technology skin patch that displays a user’s heart rate in real time. It is composed of an expandable screen and a PPG sensor and can be applied to health monitoring devices.
Israeli company Biobeat’s chest sensor, the home version of which was launched last year, is also able to continuously track 14 vital signs, including blood pressure and heart rate variability.