Three Minnesota companies were awarded their first Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) approval from the FDA for neuromodulation devices between June 2014 and January 2015. Activity in the state spans all major target regions of the nervous system: brain, spine, and periphery. The Minnesota medical device ecosystem is tailored for active implantable technology and electrotherapeutics. Technical expertise is available for all stages of a product’s life-cycle, including pre-clinical research, product development, and commercialization. The Mayo Clinic and University of Minnesota are leading research institutions that attract world-class scientists and clinicians. Both institutions invest competitively in active programming to engage industry partnerships and promote technology commercialization. Minnesota’s early and continued foothold in the medical device industry provides a mature foundation, open for innovation and entrepreneurship in neuromodulation.
The global market for neuromodulation devices is strong and projected to double by 2018, reaching $6-7 billion. Minnesota-based Medtronic and St. Jude Medical account for 72% of worldwide sales
- 27 companies with major operations in Minnesota with more than 40 FDA-registered neuromodulation devices.
- 42 companies providing products and services.
- 25+ research and clinical centers for neuromodulation and related expertise.
- $1 billion in federal research funding and life science investments in 2014.
- Minnesota is ranked 1st in US for: electromedical manufacturing employment;6 medical device patents; and PMA / 510(k) awards from FDA for complex neurological devices.
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