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FDA

Corvia Medical and physIQ Partner in Global Phase 3 Heart Failure Clinical Trial to Leverage Novel Digital Endpoints

The 100+ site global Phase 3 clinical trial is the first-of-its-kind to leverage continuous multivariate wearable sensor data and Artificial Intelligence-based analytics The landmark trial endpoint approach aligns with commentary at a recent FDA Public Workshop on biomarkers for heart failure clinical trials To date, hundreds of thousands of hours of continuous multivariate sensor data […]

Healthy.io Raises $60 Million in Series C Funding and Receives FDA Clearance for Smartphone-Based Test to Diagnose Chronic Kidney Disease

Former Aetna executive Gary Loveman will join Board of Directors Tel Aviv, Israel (September 12, 2019) ⁠— Today, Healthy.io, the global leader in turning the smartphone camera into a clinical-grade medical device, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney […]

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 […]

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 […]

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 […]

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