Medical Device Developer to Seek More Health Canada Licenses and Regulatory Approvals in Europe, Israel, Brazil, Mexico and Australia
Medical Device Developer to Seek More Health Canada Licenses and Regulatory Approvals in Europe, Israel, Brazil, Mexico and Australia
TORONTO, May 9, 2019 /PRNewswire/ -- Resolve Digital Health (“Resolve” or the “Company”), a Canadian developer of intelligent cannabis solutions and innovative technologies, today announced that the Company will seek Health Canada approval as a Medical Device License for two more of its smart vaporizers for use with cannabis.
Following the recent successful license approval by Health Canada of the Resolve MD as a medical device, the Resolve Mini MD and the Resolve Go MD will also be submitted for Medical Device License approval. The Resolve Mini MD is a dried cannabis vaporizer featuring the same technology as the Resolve MD in a smaller form factor and without a touchscreen. The Resolve Go MD is an oil vaporizer and, if approved, would become the first cannabis oil vaporizer to be granted a Medical Device License by Health Canada. Initially, the Resolve Go MD will focus on the CBD oil medical cannabis market, and then expand as increased legalization provides more options to patients.
“Resolve’s mission is to serve patients,” says Rob Adelson, CEO of Resolve. “That means everything we innovate must first meet patient needs, be safe and exceed all regulatory requirements. It doesn’t hurt that our devices are uniquely different and extremely cool, too.”
All of Resolve’s medical cannabis vaporizers assist the patient in taking control of their healthcare, utilizing technology that ensures consistent dosing and a professional experience. Further, to make usage as easy as possible for the patient, the Company is partnering with licensed producers to fill proprietary pods and cartridges with pre-selected cannabis formulations that are then simply inserted into the device. Beyond devices, Resolve develops apps that assist patients in capturing data on medical conditions, prescriptions, family history, lifestyle, and effectiveness per dose, then utilizes those data points to improve the medical cannabis treatment experience for patients and caregivers.
Beyond making further applications to Health Canada, the Company has its sights set on the global market and to this end is working towards:
- certification for its medical devices in the EU, with plans on launching in Germany in 2020;
- meeting the requirements in countries such as Germany and the United Kingdom for Resolve’s ecosystem to be fully reimbursable to patients;
- medical devices approval and registration by the Therapeutic Goods Administration in Australia with a launch planned for 2020;
- satisfying regulatory requirements in Israel; and
- obtaining regulatory approval for its devices in Central and South America, particularly Mexico and Brazil.
“There are massive markets forming all over the world,” Adelson explains. " For example, Europe is expected to be the world’s largest legal cannabis market with a population of more than double that of the United States and Canada combined, estimated to be €123 billion by 2028.* This market is going to be heavily focussed on medical patients, data and dosing technology. Resolve intends to be a leader in this market with approved medical device technology, medical formulations and reimbursement programs in several countries.”
For more information, please visit www.resolvedigitalhealth.com
*The European Cannabis Report, 4th Edition. Prohibition Partners. January 2019
About Resolve Digital Health
Resolve Digital is positioned to be the leading provider of cannabis-related business solutions and technologies for the health and wellness markets. The Company’s cloud-based health information platform, apps and family of innovative devices with metered dosing address the numerous issues with currently available methods of cannabis delivery - establishing a data-driven standard of care for the cannabis industry. After three years of research and development, the Company’s first products will soon be available in Canada.
View original content:http://www.prnewswire.com/news-releases/resolve-digital-health-goes-global-300846802.html
SOURCE Resolve Digital Health