FDA

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.  […]

FDA Releases Statement on Steps They’re Taking to Prevent Medical Device Shortages

Statement from FDA Commissioner Scott Gottlieb, M.D., on steps the Agency is taking to prevent potential medical device shortages and ensure safe and effective sterilization amid shutdown of a large contract sterilization facility A critical focus for the FDA is preventing and mitigating potential medical product shortages. As part of these efforts, we’re taking steps […]

Medical Alley Companies Raise The Bar Again

Records Fall in Q1 As Money Flows Into Medical Alley’s Startup and Growth-Stage Companies After setting a record with their best-ever Q1 in 2018, Medical Alley startup companies didn’t just set the record again, they shattered it! For the third consecutive year, Medical Alley startup and growth-stage companies broke the previous record for money raised […]

You Can’t Spell Medical Without “AI”

By Lauren J.F. Barta and Timothy E. Grimsrud Innovative medical and healthcare applications of artificial intelligence (AI) are everywhere:  Mayo Clinic is engaged in a pilot program using a customized version of IBM Watson to match patients to its clinical trials.  Cleveland Clinic is using AI for surgical volume forecasting, and Johns Hopkins is using […]

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? […]

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