Roundup: First insomnia DTx in South Korea gets regulatory nod and more briefs

South Korea clears first local insomnia DTx 

The South Korean Ministry of Food and Drug Safety has given its first market approval for a digital therapeutic device for treating insomnia, according to a news report.

The mobile-based medical device-as-a-software called Somzz by Aimmed delivers a CBT programme that helps increase sleep duration.

India OKs health monitoring smartwatch CardiacSense

Xplore Health, a medical tech company in India, has received approval from the Indian Regulatory Authority for a wearable health monitoring device it carries.

The company is the distributor of the medical smartwatch product of Israeli medical device developer CardiacSense.

Based on a news report, the smartwatch enables continuous monitoring of vital parameters and is able to prompt an ECG reading when a wearer’s heart rate fluctuates. It also allows such health data to be instantly shared with their care team for further assessment. 

The approval comes ahead of its commercial launch of CardiacSense, which has also been approved by the US Food and Drug Administration and is available in over 40 countries worldwide.

Mindray launches wireless ultrasound system

Chinese medical device company Mindray has unveiled a new wireless handheld ultrasound system that delivers high-quality images while consuming less power.

The device called TE Air is able to do this as it is powered by Mindray’s eWave platform and second-generation Single Crystal technology, a press release noted.

It is also said to be easy to use in multiple medical settings and has features such as exam presets and a number of imaging modes.

The water and dust-proof device also pairs with a mobile app for Android and iOS devices, which allows one-handed operation at any location. It can also integrate with HIS and can collect and share de-identified data.



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