Lexington Biosciences Inc. (LXGTF)

[maxcaviar]

"In recent weeks, the FDA has been targeting technology and more specifically, that of medical devices that can be worn & self analyzed by their wearers. Right now, it would appear that the first to market have been targeting one of the biggest threats to human health, which is heart disease."

"The Food and Drug Administration has just cleared AliveCor’s Kardiaband EKG reader as the first medical device accessory for the Apple Watch. The new Apple Watch accessory, Kardiaband, clicks into a slot on the Watchband to detect abnormal heart rhythm and atrial fibrillation (AFib).

Similarly, Lexington Biosciences (OTCQB:LXGTF), a Canadian corporation, has a technology of its own. Instead of simply recording cardiac function, their device called HeartSentry focused on measurement of endothelium functions. If you aren’t savvy in biotech jargon, the endothelium is made up of the cells that line all arteries and are critical to the prevention of atherosclerosis, heart attacks and stroke.

According to the company, “The unit is designed to utilize Bluetooth and Cloud technology to provide up-to-date and accurate readings of an individual’s complete cardiovascular health via electronic monitoring for risk-assessment and treatment effectiveness targeting the prevention of heart attack and stroke.”

On Thursday, the company formally announced that it had engaged a clinical research organization to help Lexington handle upcoming pilot clinical studies of its HeartSentry. This announcement came several weeks after the company initially received its first human use trial units.

In a previous announcement, company President, Eric Willis explained, “We look forward to being able to commence study enrollment in our upcoming HeartSentry clinical study in order to gather the foundational dataset aimed at supporting FDA clearance.”

https://seekingalpha.com/instablog/10425141-small-cap-reporter/5079304-fda-s-focus-medical-devices-grabbing-investor-attention