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Company, NC State Partner on Tissue Oxygen Patch

Profusa Inc. and a research center at North Carolina State University are developing a new device to monitor tissue oxygen levels in people with peripheral artery disease. . . . → Read More: Company, NC State Partner on Tissue Oxygen Patch

Neuro Device Company to Begin Clinical Trials in Europe

Clinical trials in Europe are set to begin to test a non-invasive device that stimulates nerves and the spinal cord to treat neuromotor disorders. . . . → Read More: Neuro Device Company to Begin Clinical Trials in Europe

Mobile Heart Monitor Algorithm Approved in Europe

AliveECG app on an Android device (AliveCor Inc.)

22 January 2015. An algorithm analyzing signals to detect atrial fibrillation from a heart monitor built into mobile devices received regulatory approval in Europe. AliveCor, a developer of heart monitoring systems for mobile devices, says the company received the Conformité Européene or CE mark for . . . → Read More: Mobile Heart Monitor Algorithm Approved in Europe

Nerve-Blocking Treatment for Diabetes Approved in Europe

(National Institutes of Health)

29 September 2014. EnteroMedics Inc., a medical device developer in St. Paul, Minnesota, says marketing approval in Europe for its vagus nerve blocking device for obesity is extended to cover type 2 diabetes. A CE Mark, which signifies approval to market regulated products such as medical devices in the . . . → Read More: Nerve-Blocking Treatment for Diabetes Approved in Europe

Diabetes App Developer Files for FDA Pre-Market Clearance

Dario app screen (LabStyle Innovations Corp.)

LabStyle Innovations Corp. in Caesarea, Israel, developer of a mobile and cloud-based system for diabetes management, filed for pre-market notification of its system with the U.S. Food and Drug Administration. Pre-market notification, once granted by FDA, clears medical devices for marketing in the U.S.

LabStyle Innovations created the . . . → Read More: Diabetes App Developer Files for FDA Pre-Market Clearance

CE Mark Approved for Migraine Implant Therapy

PNS illustration (St. Jude Medical)

St. Jude Medical in St. Paul, Minnesota says it received the European CE Mark approval for its implanted neurostimulation device for patients with chronic migraines. The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU health, safety, and environmental requirements for . . . → Read More: CE Mark Approved for Migraine Implant Therapy

CE Mark Awarded for Male Urinary Health Device

American Medical Systems (AMS) of Minnetonka, Minnesota, announced today it has received the Conformité Européenne (CE) Mark for AdVance XP, an implant for the treatment of male stress urinary incontinence (SUI). The CE marking certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety.

Male SUI is a common . . . → Read More: CE Mark Awarded for Male Urinary Health Device

Coronary Stent Approved for Sale in Europe

Devax Inc., a medical device developer in Lake Forest, California says it received the Conformité Européenne (CE) mark for its AXXESS stent system designed for the treatment of coronary and vascular bifurcation lesions. The CE mark certifies that a product has met EU health, safety, and environmental requirements, allowing the company to market the stent . . . → Read More: Coronary Stent Approved for Sale in Europe