MY01 Continuous Compartmental Pressure Monitor granted Breakthrough Device Designation from the FDA

NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) — Emanate Biomedical, Inc., a medical technology company creating a new category of clinician-directed at-home oral care, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for Perio PODS™, a periodontal wound dressing consisting of single-use, patient-matched dental trays preloaded with engineered hydrogel.

WASHINGTON, D.C. – AdvaMed today announced that Juan Carlos “JC” Scott has been appointed Chief Strategy Officer and Executive Director of AdvaMed Accel, a newly created leadership position focused on accelerating engagement with emerging medical technology companies and strengthening AdvaMed’s role at the center of the innovation ecosystem.

Experience the future of health care at the 2026 Medtech Showcase and Reception on Capitol Hill. Join AdvaMed® on September 16 for an interactive event featuring more than 25 medtech companies demonstrating breakthrough technologies that are transforming patient care. See innovative medical devices firsthand, connect with industry leaders and policymakers, and discover how medtech innovation is improving and saving lives.

MAPLE GROVE, Minn., June 30, 2026 — Francis Medical, Inc., a medical device company dedicated to advancing minimally invasive therapies for urological cancers, today announced the publication of the initial report from its VAPOR 2 pivotal clinical study in The Journal of Urology, one of the world’s leading peer-reviewed urology journals.

EAGAN, Minn. – June 9, 2026 – Sonex Health, Inc. (Sonex Health) and The Institute of Advanced Ultrasound Guided Procedures today announced publication of six-month data demonstrating the safety and efficacy of ultrasound-guided carpal tunnel release (UGCTR) using UltraGuideCTR™. The study, published in the Journal of Hand Surgery Global Online, represents the largest prospective evaluation of UGCTR to date.

IRVINE, Calif., April 28, 2026 /PRNewswire/ — Esperto Medical™ today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) award from the Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Mission Office to develop its next-generation continuous blood pressure monitoring solution. The project, titled “Continuous, Non-invasive, Calibration-Free Blood Pressure Monitoring by Resonance Sonomanometry,” will adapt Esperto’s proprietary resonance sonomanometry™ (RSM) technology into a wearable, wireless device suitable for home and ambulatory blood pressure monitoring.

IRVINE, Calif., May 7, 2026 /PRNewswire/ — Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Glean® Abdominal Sensor. This new sensor expands the capabilities of the Glean® Urodynamics System to include multi-channel urodynamic studies. This comprehensive system enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with LUTD and other urological conditions.

BALTIMORE, April 23, 2026 /PRNewswire/ — Neurava Inc., an innovative medtech startup focused on advanced wearable monitoring solutions for epilepsy, today announced that it has been awarded a $4 million NIH Blueprint MedTech Optimizer award to support the development of a Sudden Unexpected Death in Epilepsy (SUDEP) risk stratification and forecasting algorithm. The up-to four-year award will enable Neurava to develop, validate, and integrate a first-in-class quantitative SUDEP risk assessment platform, with the goal of advancing to first-in-human clinical trials.