RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Lepu Medical Technology Beijing’s AI-ECG Tracker, a dynamic artificial intelligence-supported electrocardiogram analysis software developed by its wholly-owned Shenzhen Carewell Electronics unit, has gained registration approval from the US Food and Drug Administration.
This marks the company’s latest global market milestone after the tracker obtained certification in the EU last year, Lepu said in a statement yesterday.
The software improves the detection efficiency of non-persistent arrhythmias — irregular heartbeats — that are hard to find in conventional static electrocardiogram examinations, above all the detection rate of transient arrhythmias, and provides patients with the most dynamic monitoring.
The firm’s shares [SHE:300003] were up 0.42 percent to CNY35.94 (USD5.07) in the afternoon after rising 1.4 percent to CNY36.81 in the morning.
The device can be used in hospitals, clinics, physical exam and community health centers, especially in primary medical institutions that lack professional doctors and help doctors interpret real-time data quickly and accurately, per the statement.
One of the invention patents included in the apparatus has been authorized in China, and the remaining patents have also entered the review stage there and in the US and EU, according to the statement, which offered no further details as to the business plan for the product in the overseas market.
The artificial intelligence static ECG data analysis software AI-ECG Platform the unit developed has already gained certification from the FDA and EU, per the statement, which made no mention of the overseas market development strategy for this product.
Carewell Electronics has pioneered the application of artificial intelligence in ECG auto-diagnosis. It focuses on producing high-quality, innovative AI medical devices that it sells in more than 100 countries, information on its website shows.
Source: Yicai Global
