Medical Device – Medical Alley Association

Medical Device

BARDA Industry Days

By Diane Rucker (UEL) Kate Evinger (gener8tor) and I joined BARDA Industry Days last week in Washington, DC.  In September, University Enterprise Labs (UEL) and gener8tor announced a partnership to support startups in health security, funded by a federal grant.  (The federal government loves acronyms.  I’ll include translations in the article.) But first, some fun […]

RxFunction Announces walk2Wellness Study Expansion with Hebrew SeniorLife

Hebrew SeniorLife, a Harvard Medical School Affiliate, is Fourth Study Site  Eden Prairie, MN – (October 23, 2019) – RxFunction, the medical device company that created Walkasins®, is announcing expansion of its walk2Wellness study to include researchers at Hebrew SeniorLife, with enrollment of its first participant completed earlier this month.  The Hinda and Arthur Marcus […]

NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany

DAkkS, the sole national accreditation body for the Federal Republic of Germany, oversees ISO/IEC accreditation in the region, which is the single most important standard for testing laboratories around the world. ISO 17025 accredited facilities, which now include NAMSA’s state-of-the-art Analytical Services Laboratory in Obernburg, Germany, have demonstrated technical proficiency, as well as precise, accurate test data for […]

Surprising New Themes Emerge at DeviceTalks Minnesota 2019

DeviceTalks Minnesota has a reputation for debuting the latest innovations in medical devices as well as bringing top-notch speakers to the dais, so it wasn’t a surprise that both of those features were present again in 2019. However, an unexpected theme emerged from many of the speakers. Whether they were talking about innovations in engineering […]

Visualize MED: Modeling the Future of Medicine

The medical device industry has traditionally relied on a combination of bench testing, animal testing, and clinical trials to guide the development and evaluation of medical devices. Indeed, regulatory agencies around the globe have established their approval processes around these three sources of evidence. In the mid to late 2000’s, it became clear that our […]

MAA Member Discount to MD&M 2019

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preCARDIA Enrolls First Patient in Early Feasibility Study

Company initiates the VENUS-HF study in patients with Acute Decompensated Heart Failure (ADHF) ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), has enrolled the first patient in the VENUS-HF Early Feasibility Study at Tufts Medical Center in Boston by Dr. Carey Kimmelstiel, Director, […]

2019 First Half Investment Report

Three Key Takeaways: M&A activity is strong in Medical Alley, with over $15 billion spent in the second quarter alone, as companies large and small look for paths to growth Medical Alley startups brought in $261.6 million dollars in the first half of the year, their second-best mark in the last five years Signs point […]

Bio-Techne Announces Commercial Release of RNAscope HiPlex Assay: A Multiplex in SITY Hybridization Assay for Tissues

Expanding research tools for Spatial Genomics by combining molecular information with spatial context in one simple assay.  MINNEAPOLIS, July 11, 2019 /PRNewswire/ — Bio-Techne Corporation (NASDAQ:TECH) today announced the expansion of the Advanced Cell Diagnostics™-branded RNAscope platform with release of the RNAscope HiPlex Assay. The RNAscope platform is an advanced in situ hybridization assay that […]

Reprise Biomedical Raises $12.5 Million and Completes Spin-Off From Miromatrix Medical

New Minnesota-based medical device company focuses on biological medical devices manufactured using perfusion decellularization technology. Minneapolis, Minn. (July 1, 2019) – Reprise Biomedical, Inc., a Minnesota-based startup focused on commercializing biological medical devices manufactured using a proprietary perfusion decellularization technology, has successfully completed a $12.5 million private placement and commenced operations as a spin-off from […]

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