Centech Acceleration Fall 2022 Medtech Cohort Regulatory Affairs Workshop facilitated by BML Technology Managing Director Marc Saab

The Centech Montreal technology startup incubator and accelerator program has become one of the most active and successful programs of its type in the Montreal technology startup ecosystem and beyond. A non-profit organization, Centech supports high-tech companies and projects with high growth potential, from conceptualization to commercialization, thanks to a bold, collaborative and passionate ecosystem. […]

BML Technology Founder and Managing Director Marc Saab conducted a Regulatory Outlook Roundtable in partnership with DHIT

We’re excited to announce that our Founder and Managing Director, Marc Saab conducted a Regulatory Outlook Roundtable in partnership with Raleigh, NC based DHIT, the Digital Health Institute for Transformation, that took take place on October 19th, 2022 at 4:30 PM in the North Carolina Research Triangle city of Raleigh. The event took place prior […]

Precision Neurology startup Rune Labs obtains FDA 510(k) clearance for their Apple Watch based Parkinson’s Disease software platform

In yet another in a fast growing list of impressive usage cases of remote patient monitoring technology transforming an Apple Smartwatch into a consumer wearable medical device; precision neurology startup Rune Labs announced its StrivePD software ecosystem for Parkinson’s disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to collect […]

Three important regulatory challenges to consider for digital health and medical technology startups

The pace of innovation and technological advancement in the digital health industry has never been higher. Record levels of venture capital investment have fueled a wave of new medical devices, technologies and innovation that are changing the way healthcare is delivered. Medtech startups are taking on some of the greatest challenges to human health and […]

U.S. FDA authorizes EaseVRx virtual reality system for treatment of chronic lower back pain

A significant development for digital therapeutics and digital health solutions with clinical indications has taken place. The US FDA has granted market authorization in the US to the EaseVRx virtual reality system from AppliedVR indicated for the treatment of chronic pain. EaseVRx is the first and only FDA-approved at-home immersive virtual reality (VR) pain treatment indicated as an adjunct treatment for […]