Vibrato Medical Closes $4M Series A Funding Round and Receives $1.5M NIH Grant

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.

WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would “expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare,” according to FDA.

Join PwC to explore how compliance leaders can proactively support deal activity across the transaction lifecycle.

Join cyber experts for the 2026 Cybersecurity Summit to address the latest industry issues and FDA requirements.

Saint Paul, MN – April 15, 2026. Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices and delivery systems utilizing proprietary technologies, is pleased to announce that its InjecSURE® Injection System has received clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) pathway. This milestone marks the introduction of a new accessory system designed to support the delivery of syringe-based injectable materials into urethral tissues during cystoscopic procedures.