FDA

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 […]

Up & Running with Brian Brockway, President and CEO of VivaQuant

Brian Brockway is the founder of Data Sciences Intl. (DSI), the leading provider of wireless implantable sensors and systems for preclinical testing of new drugs and biomedical research. He bootstrapped DSI with SBIR grants into a highly profitable business with over $40 million in revenue where he developed domestic and international direct sales and distribution […]

As Mobile Health Tech Rises in Popularity So Do the Privacy and Security Risks

By Paul H. Luehr and Doriann H. Cain Electronic medical devices have long been a part of healthcare. From x-ray machines to infusion pumps, these devices have helped push major advancements in clinical care. But increasingly, we see healthcare technology moving out of controlled clinical settings. From Bluetooth-enabled blood pressure cuffs to fitness bands and […]

FDA Grants Breakthrough Device Designation to Bio-Techne ExoDx™ Prostate Intelliscore™ (EPI) Test

MINNEAPOLIS, June 17, 2019 /PRNewswire/ — Bio-Techne today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its ExoDx Prostate IntelliScore (EPI) test, making it the first exosome-based liquid biopsy test to receive a Breakthrough Device Designation. This designation not only validates the clinical importance of Bio-Techne’s EPI test, […]

FLEX Vessel Prep™ System Data Presented at New Cardiovascular Horizons Conference Shows Key Findings including Luminal Gain

Toledo, Ohio, June 4, 2019 – VentureMed Group, Inc., a privately-held medical device innovator in vessel preparation for interventional treatment of peripheral arterial disease (PAD) and stenoses of arteriovenous (AV) fistulas and grafts, announced new data presented at the 20th Annual New Cardiovascular Horizons (NCVH) Annual Conference, May 29-31, in New Orleans, Louisiana. FLEX iDissection […]

New Headache Care Program Connects Patients to Latest, Advanced Headache Treatments

MINNEAPOLIS, Minn. – More than four million people in the United States suffer from chronic migraines, experiencing at least 15 migraine days per month. 44 percent of people experiencing severe headaches or migraines are never diagnosed. University of Minnesota Health has launched a new Headache Care program to help Minnesotans gain quick access to specialized […]

SilkTech Biopharmaceuticals’ IND Submission Cleared by FDA; Phase 2 Clinical Trial Initiated for Patients with Dry Eye Disease

Milestone Results in $6.2 Million in Additional VC Funding Minneapolis, MN – April 16, 2019 – PRWeb – SilkTech Biopharmaceuticals, a company devoted to improving eye health through the development of silk-derived protein biotherapeutics for the targeted treatment of Dry Eye Disease (DED), today announced the company has received clearance of its Investigational New Drug […]

FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

One in Two Women in the United States Will Suffer a Fracture in Her Lifetime Due to Osteoporosis(1) EVENITY is the First and Only Bone Builder With a Dual Effect That Both Increases Bone Formation and Decreases Bone Loss(2) EVENITY Rapidly Reduces Fracture Risk and Builds New Bone With 12 Months of Therapy(2) THOUSAND OAKS, […]

2019 Q1 Investment Report

Healthcare’s Move from Volume to Value Fuels Startup Investment As industry leaders work to redefine value in healthcare, payers and providers are offering access to the once-impenetrable healthcare marketplace for new technologies. As large healthcare systems and payers expand their own investment portfolios, they are becoming familiar with the value that startups can drive and […]

Magstim TMS Receives FDA Clearance For 3-Minute Theta Burst Treatment

Magstim has received FDA clearance to include intermittent Theta Burst Stimulation (iTBS) as a treatment for Major Depressive Disorder with its Horizon ® TMS Therapy systems. The Horizon ® system was designed to offer more versatility in one system, and more treatment options for patients.  This clearance allows Magstim to market the 3-minute iTBS protocol.  […]

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