FDA

Medical Alley Association Statement on Announcement of FDA Commissioner Scott Gottlieb’s Resignation

FOR IMMEDIATE RELEASE: March 5, 2019 Medical Alley Association Statement on Announcement of FDA Commissioner Scott Gottlieb’s Resignation GOLDEN VALLEY, MN – The Medical Alley Association issued the following statement on the resignation of FDA Commissioner Scott Gottlieb: “The Medical Alley Association, on behalf of our 600 members that represent every sector of healthcare, thanks […]

At The Table – March 4, 2019

State Representatives Boe, Klevorn Tour Medtronic Facilities State Representatives Ginny Klevorn (DFL – Plymouth) and Greg Boe (GOP – Chaska) each recently visited Medtronic facilities in their respective districts to better understand how Minnesota’s health technology and innovation cluster has benefitted their constituents. Representative Boe toured Medtronic’s Care Management Services facility, a telehealth site focused […]

The Legal Risks of Genetic Data

By Christin Jaye Eaton and Jeff Wojciechowski Recent scientific and technological breakthroughs have enabled medical product manufacturers to analyze genetic data, which can unveil links between genetic traits and certain reactions to drugs or other products. But when must manufacturers use that data? What action must a manufacturer take when genetic data illuminates patient risk? […]

For The Record with David Kaysen

David has more than 35 years of experience leading and managing both domestic and international emerging growth companies. He has achieved consistent and solid results with bio-pharmaceutical, medical device, and clinical software/IT companies. He is also experienced in the FDA approval process, as well as leading products to revenue growth. Kaysen currently serves in board […]

In The Know: Medical Alley News for January 21, 2019

FDA adds back some workers during partial government shutdown University of Minnesota tests ‘smart’ pills to give cancer patients a nudge Denmark picks Minnesota as its ‘bridge’ to U.S. med-tech A Pea-Sized Device Is Approved to Close Holes in Hearts of Tiny Infants Zoll Medical wins $400m DoD patient monitoring supply contract Ecolab Closes on […]

MedTech Innovator Opens Applications for Global Showcase, Competition and Accelerator

2019 Showcase to Feature Industry’s 50 Best-in-Class Medical Technology Startups LOS ANGELES, Nov. 28, 2018 – MedTech Innovator, the premier nonprofit accelerator in the medical technology industry, today announced a call for startups and emerging growth companies to apply to its 2019 program, which will award up to $500,000 in cash and in-kind prizes during its competition. The deadline […]

Top Healthcare News for November 8, 2018: In the Know

Governor Dayton Proclaims “Earl Bakken Day” in Minnesota NeoChord raises $25m in Series D Fairview Launches Innovative Workplace Behavioral Health Service for Employers CardioMech Appoints Richard Nehm as President and CEO, and Mark Novotny as Chairman With new FDA clearance, Abbott Freestyle Libre users can ditch handheld readers for an app Eight New Operating Rooms […]

Health Care Startup Day Minnesota Highlights Innovative Work in Minnesota

This week, the University of Minnesota and the Medical Alley Association had the privilege of hosting the U.S. Department of Health & Human Services (HHS) for Health Care Startup Day Minnesota. The event took place on University of Minnesota’s campus and drew the largest crowd HHS had seen for one of these events to date. […]

June 19, 2018: Capitol News

St. Paul Mayor Carter Addresses DeviceTalks Minnesota Earlier this month, on June 4th and 5th, St. Paul hosted DeviceTalks Minnesota – where medical device and technology industry leaders came together to share perspectives and network with the best of the best in the industry. One of the featured speakers was they Mayor of St. Paul, […]

FDA, State of Minnesota Announce Programs for Health Technology Companies

Two new programs aimed at bringing critical innovations to market more quickly have recently launched and Minnesota’s health technology companies are in perfect position to take advantage of them! The first, open to medical device, diagnostic, and digital health companies, is an FDA Innovation Challenge aimed at preventing and treating opioid use disorder. Companies can […]

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