Device Approvals Archives - Page 6 of 6

Do FDA Regulations of Medical Devices Need to be Reevaluated?

According to an article from the Wall Street Journal, “The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s...

FDA Issues Final Guidance for Labeling and Instructions for Reprocessed Med Devices

According to MassDevice.com, “The US Food and Drug Administration has released final guidance on how manufacturers of reusable medical devices should validate instructions for these products.” Four categories fall into the new guidance’s outline:...

FDA Approves New Atrial Fibrillation Device

The FDA has approved Boston Scientifics new device for stroke patients with irregular heart rhythm known as atrial fibrillation, and will be made available to U.S. centers involved in Boston Scientific’s clinical studies and additional specialized centers,...

FDA Grants Investigational Device Exemption for Afib Study

AtriCure said has won an investigational device exemption from the FDA for a first-of-its-kind clinical trial involving patients with non-paroxysmal atrial fibrillation, according to MassDevice. The trial will combine ablation outside the heart and...

Press Release: Registration Now Open for 4th Annual Medical Device Regulatory Clearance & Approval Conference

Regulatory Approvals in China, 510(k) Guidance Among This Years’ Discussion Topics (Chicago, IL) – For the fourth straight year, Q1 Productions will host the annual Medical Device Regulatory Clearance and Approval Conference, offering regulatory affairs...

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