FDA

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 […]

Key Takeaways from FDA Public Workshop Fostering Digital Health Innovation

A summary provided by Medtronic, PLC Members, as many of you know the FDA is piloting a Pre-certification program for certain digital health technology products. On January 30-31st the FDA hosted a public workshop. Representatives of Medtronic that participated shared their high-level notes with Medical Alley Association for the benefit of interested parties that were not […]

EP Vantage Pharma & Medtech 2017 Review

In the early weeks of 2017 biopharma investors were preoccupied with working out whether the year would head up or down. Put generously, 2016 had been flat, and hopes were high that the months ahead would see a recovery. On most measures, 2017 delivered a resurgence. And the picture was similar for the medical technology industry, though life got […]

AUM Cardiovascular Receives FDA Approval for Revolutionary Diagnostics Heart Device

NORTHFIELD, MINNESOTA (August 8, 2017) — AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,™ a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs. The reusable, non-invasive, radiation-free handheld device, which is now available in the United States, records sounds originating […]

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