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Recent News & Publications » » »

NEWS

SpinTech Receives FDA 510(k) Clearance for STAGE Technology

NeuMoDx Molecular Gains FDA 510(k) Clearance for NeuMoDx™ 288 Molecular System and NeuMoDx™ GBS Assay 

MDRS, LLC is a member of the Regulatory Assessment and Consulting Team for the NIH funded MPW REGENERATIVE MEDICINE RESOURCE CENTER: 2017-2019

VC's Advice To Healthcare Startups: Build Your Business in the Midwest, It's Cheaper By Scott Wooldridge - MedCity News May 2014

Reimbursement Challenges For Medical Device Makers, Manufacturing Engineering Magazine, March 2013

Tangent's NovaCath™ Receives FDA 510(k) Clearance

Tangent Named Most Innovative Company, 2013

PUBLICATIONS

 

Textbook Chapter:

Kaigler, D, Fuller, KL, Giannobile, WV, Regulatory Process for the Evaluation of Dental Drugs, Devices and Biologics In: Giannobile, WV, Burt, B, Genco, R. ed, Clinical Research in Oral Health, Wiley-Blackwell, released March 2010

 

National Cancer Institute: Network For Translational Research (NTR) Optical Imaging In Multimodal Platforms (U54): Year 1 Report: RFA-CA-08-002

http://imaging.cancer.gov/programsandresources/specializedinitiatives/ntroi

 

Patents:

Fuller, et al., Integral Fluid Regulator For Endoscopic Vessel Dissection/Harvesting Device. US Patent No. 8,337,412 Dec 25, 2012

 

Journal Articles:

Support for Investigator-Initiated Clinical Research: The Clinical Translational Science Award (CTSA) Experience, Academic Medicine: February 2011 - Volume 86 - Issue 2 - pp 217-223; NIH-CTSA National IND/IDE Taskforce, co-author

 

Baman, TS, et al.,Pacemaker Reutilization: An Initiative to Alleviate Symptomatic Burden Associated with Bradyarrhythmia in Impoverished Nations Around the World, AHA Circulation, October 19, 2010

Medicine at Michigan Magazine: From Mind to Market by Sally Pobojewski

http://www.medicineatmichigan.org/magazine/2009/summer/mind