PneumoWave Achieves Major Milestones with ISO13485:2016 Certification and UKCA Class 1 Registration.

February 29, 2024

[North Charleston, SC, February 29, 2024] PneumoWave, an innovator in the fight against the opioid epidemic, is proud to announce that it has achieved ISO 13485:2016 certification and has registered a version of its technology as a Class 1 UKCA device.

ISO 13485:2016 accreditation marks a pivotal moment for PneumoWave, demonstrating its commitment to developing safe, reliable, and effective solutions for healthcare providers, payors, and patients globally.

Richie Bavasso, President at PneumoWave, shared his excitement for the achievement: “Achieving ISO13485:2016 certification and registering as UKCA Class 1 is a milestone for PneumoWave because it pushes us forward in our mission to develop life-saving technology for people at risk of opioid related harm – in particular, overdose. These endorsements enable us to further our goal of delivering innovative, real-time monitoring solutions that can make a significant difference in the lives of those affected by opioid use disorder.”

PneumoWave received Breakthrough designation from the FDA for its ALERT prescription medical device for detection of overdose. The device is currently under development in an international program of clinical research, to establish performance characteristics and is not yet commercially available.

When available, the ALERT medical device will be offered to Outpatient SUD Clinics, MATProviders, Primary Care Physician Practices, and Critical Access Hospitals via PneumoWave’s THRIVE Care Process Model for remote care, monitoring and intervention for people who use substances.

About PneumoWave

PneumoWave aims to revolutionize the response and management of Opioid Dependence and Mental Illness with a virtual-first approach for clinicians that harnesses the power of AI. We partner with those who are combatting the growing opioid crisis to deliver real-time physiological/behavioral data from multiple biosensors to screen, diagnose, monitor, and intervene in patients at risk for overdose.

For further information, contact:

Richie Bavasso

President, PneumoWave