Bluegrass Vascular Announces Decision by Medicare to Assign a New Technology Ambulatory Payment Classification (APC) for the Surfacer® System Procedure

AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions between real-world data and evidence.

Washington, D.C.—AdvaMed, the Medtech Association, the world’s biggest trade association representing medtech innovators, welcomed Senate introduction of the bipartisan Medical Device Electronic Labeling Act (S. 4519), which would allow medtech instructions for use to be provided electronically, with paper copies being available upon request.

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.

Early Alzheimer’s blood tests are improving diagnosis, but access depends on policy. Learn how expanded Medicare coverage is changing patient outcomes.

PALO ALTO, CA, UNITED STATES, May 4, 2026 / EINPresswire.com / — Biopharma and medtech companies face a years-long process to get their products approved. Drug and device makers navigate a full spectrum of FDA and global regulatory frameworks to move innovation forward.

The United States faces a maternal health crisis demanding urgent action. The U.S. has the worst maternal outcomes among high income nations. Our maternal mortality rates far exceed peer countries’, despite the highest per capita health care spending. Protecting mothers and improving birth outcomes provides an important opportunity for bipartisan priority leadership.

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.