MY01 Inc. Receives FDA Clearance for the MY01 Continuous Compartment Pressure Monitor as an Aid in Diagnosis of Compartment Syndrome

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.

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.

The tax incentives in the One Big Beautiful Bill Act passed by Congress and signed into law by President Trump last year are a prime example of the public policies reinforcing the U.S. position as the global leader in medtech innovation. 

AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.

 WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, thanked President Trump and Congress for enacting the Small Business Innovation and Economic Security Act (S. 3971). Signed into law, the legislation reauthorizes the federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.