The emergence of artificial intelligence (AI) and machine learning (ML) can be seen across multiple industries, transforming everything from healthcare to transportation. Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.
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News / Regulatory Affairs / Small Business
Bright Uro Receives FDA Clearance for Glean® Abdominal Sensor
May 8, 2026
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.
News / Regulatory Affairs
i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences
May 4, 2026
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.
Blog / Coverage & Payment / Government & Legislative Affairs / Health Access / Regulatory Affairs
A Policy Win for Maternal Health Innovation Through FDA–CMS Collaboration
April 27, 2026
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.
Event / Regulatory Affairs
Compliance Considerations in an Active Deals Market for Medtech
June 17, 2026
12:00 PM – 1:00 PM
Join PwC to explore how compliance leaders can proactively support deal activity across the transaction lifecycle.
Event / Digital Health / Regulatory Affairs
AdvaMed® Cybersecurity Summit
November 10, 2026
Join cyber experts for the 2026 Cybersecurity Summit to address the latest industry issues and FDA requirements.
News / Regulatory Affairs / Small Business
Carbon Medical Technologies’ InjecSURE® Injection System Receives FDA 510(k) Clearance, Expanding CMT’s Portfolio of Urology Delivery Solutions
April 16, 2026
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.
Resource / Regulatory Affairs
AdvaMed® Comment Letter to FDA: Exemptions from Premarket Notification Requirements for Class II Devices
April 15, 2026
AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.
Event / Regulatory Affairs
Pulse on MedTech: How the Industry is Reigniting Growth and Expanding Markets
April 30, 2026
11:00 AM – 12:00 PM
Join Ernst & Young LLP in this session that explores key trends shaping the sector.