Faculty Directory

Schultheis, Lex

Schultheis, Lex

Research Professor
Director, FDA Regulatory Science and Innovation Initiative
Robert E. Fischell Institute for Biomedical Devices
5102E A. James Clark Hall
Regulatory science.

CelestRay Secures FDA Clearance for Implantable Medical Device with Help from Fischell Institute

The clearance, which paves the way for CelestRay to legally market its implant, also marks the first medical device aided to market by the Fischell Institute since its launch in 2019. 

Lex Schultheis Named a Winner of the NIOSH Respirator Fit Evaluation Challenge

The challenge is a three-phase, $350,000 competition to improve respirator fit evaluation.

Fischell Foundry Spotlight: Quinn Burke

Fischell Institute staff engineer Quinn Burke (B.S.'20, M. Eng.‘22 bioengineering) provides support to the Fischell Foundry.

Fischell Institute to Test Face Coverings for Children

Fischell Institute testing aims to advance understanding of fit, efficacy of face coverings for children.

Introducing Three New MPower Fellows

The Fischell Institute is excited to introduce three new MPowering the State Student Entrepreneurship Fellows.

Researchers Aim to Sterilize N95 Masks for Reuse

Researchers working around the clock to ease the impact of supply shortages on hospitals, care facilities

Researchers Develop Rapid Deployment Mask

Fischell Institute designs DIY-style mask with better filtration than cloth masks.

Researchers Work to Develop Custom Conformal N95 Respirators

Researchers are working to address the critical supply of N95 respirators resulting from the COVID-19 crisis.

FDA Budget Request Recognizes Two NCC-PDI Devices

BabySteps and PolyVascular recognized among other NCC-PDI successes.

MPowering the State Fellows Develop Novel Shoulder Implant

Rayan Alabsi and Tejsavi Subramanya have designed a new prosthesis for RTSA patients.

Fischell Institute Faculty Present at MedTech

Drs. Lex Schultheis and Martha Wang served on panels as part of NCC-PDI's annual device symposium.

Fischell Institute Investigates Biocompatibility of 3D-Printed Dental Devices

This research will inform FDA reviews regarding patient contact with devices.