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Covid rapid breath tests developed in Finland ready for EU market | News

The wearable device sends data through a mobile app to a cloud-based service, which provides a test result within seconds.

The breath test device can provide a Covid test result in 45 seconds, the company said. Image: Markku Sandell/Yle

A Tampere-based medical device company has received an EU-wide CE certificate for the distribution of a rapid Covid-19 breath test.

The CE mark indicates that a product has been assessed and found to comply with EU requirements for safety, health and environmental protection.

“We are committed to providing a disruptive Covid testing solution that helps individuals, families and communities get back to normal at work, school and play,” said CEO Pekka Rissanen of Deep Sensing Algorithms, which developed the product, said in a company press release.

Speaking to Yle on Monday, Rissanen confirmed that the company was now cleared to sell the device within the EU, adding that the rapid Covid breath test would be the first of its kind to enter the commercial market.

Yle first reported on the development of the device last February. It aroused considerable interest at the time because it provides results quite quickly and would be particularly useful for control by border guards or at airports.

Test subjects breathe into the wearable device, where nanosensors analyze their breathing. The data is then sent via a mobile app to a cloud-based service which provides a test result in around 45 seconds.

“Human defense mechanisms begin immediately after infection, and metabolic byproducts of the person’s immune response begin to appear in exhaled breath on the same day,” the company explained in the statement.

The device is manufactured in Turku, but the quantity produced will depend on the orders.

“I can’t provide revenue forecasts at this point. The business model is two-part, we get money for the device and from how much it’s used,” Rissanen explained, but added that production is currently hampered by a global shortage. of components.

“The situation is very difficult,” he said.

The breathalyser must be used by a professional as it is officially a medical device.

“Workplace health care, school health care, and dental care would be good places for the device,” Rissanen said.