Key Highlights
- LuxCreo partners with EMA Sleep to revolutionize Obstructive Sleep Apnea (OSA) treatment.
- FDA clearance granted for 3D printing of EMA device (K232735).
- EMA 3D device enables same-day in-clinic production and wider adoption.
- LuxCreo’s iLux Pro Dental platform integrates design, production, and FDA-cleared resin technology.
Source: Business Wire
Notable Quotes
- “Whether it was troubleshooting, technical support or responsiveness, I have been extremely impressed with the entire LuxCreo organization.” — Sonnie Bocala, Manufacturing Expert at EMA Sleep
- “LuxCreo is solving a critical challenge by delivering precisely customized, high-performance medical devices directly at the point of care.” — Michael Strohecker, Co-founder and CRO at LuxCreo
SoHC's Take
The partnership between LuxCreo and EMA Sleep is a pivotal moment for the sleep medicine industry, particularly for treating Obstructive Sleep Apnea (OSA). With over 40 million Americans affected by OSA, the FDA’s clearance of a 3D-printed EMA device is a breakthrough. The collaboration allows for in-clinic, same-day production, transforming patient care with faster access to personalized devices. LuxCreo’s comprehensive platform, from automated design software to workflow integration, exemplifies the future of MedTech, where innovation meets patient-centered care. This collaboration is likely to set new standards in medical device manufacturing for years to come.
