Control Bionics (ASX: CBL) has announced that its autonomous wheelchair module, DROVE, has been officially included as a Class 1 Medical Device in the Australian Register of Therapeutic Goods.
This follows almost 12 months of extensive internal and external testing to ensure the highest standards of safety and effectiveness for the company’s mobility solution.
Control Bionics now has the green light to commence commercial sales of the DROVE module in Australia and said the official launch will take place in the coming weeks.
Control Bionics is a medical device company which specialises in assisting patients whose ability to communicate is compromised by conditions such as Motor Neurone Disease (MND) and Amyotrophic Lateral Sclerosis (ALS).
DROVE is designed and manufactured in Australia to provide powered wheelchair users with independence and ease of use within their own homes. The module integrates with existing wheelchair systems, enabling users to navigate their environment autonomously and safely.
CEO Jeremy Steele said: “I am delighted for our team who have worked for years to design, test and get this device registered. I am even more excited to be able to provide independence to Australians currently living with conditions that impact their ability to control their own wheelchair.”
Mr Steele added: “Work is also progressing well on a similar approval in the US with the FDA, supported by a grant from the ALS Association received earlier this year.
“We are encouraged by the revenue growth opportunity DROVE provides Control Bionics.”
CBL was trading up 44% at 6.2 cents.