510k

Philips receives FDA clearance for the use of its ultrasound portfolio to manage COVID-19-related lung and cardiac complications

Via Philips Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related lung and cardiac complications. Handheld and portable ultrasound solutions in particular have […]

Launching a Medtech Product? Have Your Regulatory, IP and Governance Affairs in Order Before Engaging Investors

By Walter Linder, Amy Judge-Prein, and Jonathan Zimmerman Investors in medtech companies are willing to take risks. However, they will expect their investment to be put to effective use with defined objectives, and their diligence will focus on identifying potential impediments to those objectives. Because momentum is important when seeking investment, it is critical that […]

PhysIQ Inc. Receives FDA Clearance of Continuous Ambulatory Respiration Rate Algorithm Enabling Artificial Intelligence-based Analytics for Biopharma Companies and Payers

FDA 510(k) cleared Respiration Rate analytic adds to physIQ’s growing portfolio of FDA 510(k) algorithms Clearance allows physIQ to power its higher-level AI analytics with validated vital sign inputs PhysIQ’s cloud-based analytics provide flexibility to biopharma companies and payers looking for consistent output while deploying a variety of devices across different patient populations CHICAGO – PhysIQ, […]

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 […]

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 […]

Tammy Lee Named CEO of Nanocore Corporation

Company to Raise $2.5 million to Expand Production at Red Wing Plant; Internal Review Board (IRB) Study Results for Menopause Therapeutic Released at National Conference in Nashville (MINNEAPOLIS, MN May 7, 2019) – Nanocore Corporation announced Tuesday that Tammy Lee has joined as chief executive officer.  The Company’s Red Wing-based manufacturing plant currently produces and […]

Keep your finger on the pulse of Medical Alley from anywhere with the ALLEY NEWSLETTER