e2Coil System for Siemens Magnetom 3.0T

The Next Generation Endorectal Coil is Here!

DxTx Medical Receives FDA 510(k) Clearance for the 3.0T e²Coil™ Imaging System compatible with Siemens MRI Systems

PITTSBURGH, PA – July 22, 2025 — DxTx Medical, Inc., a leader in advanced diagnostic imaging technologies, announces that it has received FDA 510(k) clearance for the e²Coil™ Imaging System designed for use with Siemens MAGNETOM 3.0T MRI Systems with Tim 4G connectors.

This clearance marks a significant milestone in DxTx Medical’s mission to enhance the precision and accessibility of prostate imaging. The e²Coil™ system is a next-generation endorectal coil solution that enables high-resolution magnetic resonance imaging and spectroscopy of the prostate and surrounding pelvic tissues. The system includes the Siemens 3.0T Endo Interface Gen II with Tim 4G Slide Connect and the Endorectal MRI Coil II, designed for single-use diagnostic procedures.

“We are incredibly proud to receive this FDA clearance for the e²Coil™ system,” said Paul Lawson, Director of Quality and Regulatory at DxTx Medical. “This achievement is a testament to our team’s commitment to innovation, patient safety, and clinical excellence. The e²Coil™ builds on our legacy in prostate imaging while introducing key technological enhancements to improve image quality and procedural efficiency.”

The e²Coil™ Imaging System is engineered with dual-loop, four-channel technology to deliver superior signal-to-noise ratios and uniform signal coverage. Clinical testing demonstrated consistently improved imaging performance compared to surface coils alone.

In line with DxTx Medical’s dedication to clinician support, the device is intended for use by trained healthcare professionals and integrates seamlessly into existing Siemens 3.0T MRI workflows via the Tim 4G interface.

This FDA clearance (K243428) reinforces DxTx Medical’s strategic focus on advancing urologic imaging and delivering tools that empower physicians with greater diagnostic confidence and patients with better care outcomes. In the near future, DxTx Medical will expand the availability of the e²Coil System to include versions compatible with additional MR scanner brands, types, and field strengths to provide imaging centers with greater flexibility in use across platforms.

About DxTx Medical, Inc.

DxTx Medical is a Pittsburgh-based medical device company dedicated to developing advanced diagnostic technologies that support clinical decision-making and improve patient outcomes. With a legacy rooted in MRI innovation, DxTx Medical continues to drive progress in urologic imaging solutions.

For more information, contact us at info@dxtxmedical.com.