Cognetivity Neurosciences Sees Granting Of FDA Clearance For Cognitive Assessment Tool

Cognetivity Neurosciences (CSE: CGN) has reached a major achievement. The company has been granted FDA clearance from the US Food and Drug Administration for the distribution of its integrated cognitive assessment. The approval essentially enables the company to market its device for use within the US market.

The granting of FDA clearance follows the CognICA Integrated Cognitive Assessment meeting the regulations for a Class II Exempt Medical Device and the approval of the firms associated submission for such exemption. The firm, with the clearance, now has access to the US$3.8 trillion healthcare market within the US, the largest such market globally.

Following the approval, Cognetivity this morning commented that it intends to conducted a “vigorous business development strategy” for commercial rollout across the US. The strategy is said to include regional outposts to build upon the firms existing networks due to accelerator programs it has participated in within the country.

Speaking specifically to the Alzheimer’s and dementia market within the US, the niche is estimated to amount to a US$355 billion market in 2021, and accounts for a significant portion of the overall healthcare market. The result, is that the company anticipates strong demand for its tool geared towards the early detection of Alzheimer’s and dementia.

The tool itself consists of a five minute cognitive assessment that takes place on an iPad. The test is said to be highly sensitive to early signs of dementia, and is simplistic in nature, containing no cultural or educational bias. The test can also be delivered remotely due to its digital nature, enabling a cost effective means of early detection that can be conducted without practitioner supervision.

“We’re delighted to have reached this major company milestone, which is the culmination of many years of hard work. This grants us access to the world’s largest healthcare market, where, sadly, there is much more to be done to tackle the massive problem of dementia. Of course, we’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the US and make a positive impact on the health and wellbeing of millions of Americans,” commented CEO Dr Sina Habibi on the major development for the company.

Cognetivity Neurosciences last traded at $0.70 on the CSE.


FULL DISCLOSURE: Cognetivity Neurosciences Ltd is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Cognetivity Neurosciences Ltd on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

Video Articles

Baselode Energy To Acquire Forum Energy: The Merger Of Equals Deal

TriStar Gold: The Revised Castelo de Sonhos Prefeasibility Study

Gold is Up 30%, But the Real Bull Market is Only Starting Now! | Adrian Day

Recommended

ESGold To Expand Mine Building At Montauban In Advance Of Gold & Silver Production

Goliath Resources Expands 2025 Drill Program To 60,000 Metres

Related News

Cognetivity Sees Its Cognitive Tool Used In Clinical Study For OCD

While it may have been initially developed for the early detection of Alzheimer’s disease or...

Tuesday, September 13, 2022, 08:38:28 AM

Cognetivity Partners With UK National Health Service For New Remote Brain Health Clinic

Cognetivity Neuroscience (CSE: CGN) this morning indicated that it continues to see adoption of its...

Wednesday, July 14, 2021, 09:25:00 AM

Cognetivity Looks To Raise $3.0 Million To Fund US Expansion

Cognetivity Neurosciences (CSE: CGN) is looking to close out the year with a capital raise....

Thursday, December 16, 2021, 07:32:30 AM

Cognetivity Neurosciences Files Patent For System Capable Of Early Detection Of Alzheimer’s Disease

Cognetivity Neurosciences (CSE: CGN) this morning announced that it has filed for a key new...

Tuesday, June 8, 2021, 10:08:19 AM

Cognetivity Enters Distribution Arrangement For Dementia Product In Middle East

Cognetivity Neurosciences (CSE: CGN) is expanding its global distribution. The firm this morning announced it...

Thursday, January 27, 2022, 09:09:29 AM