Tag: FDA

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FDA Guides Return to Pre-Pandemic Medical Device Enforcement, EUA Policies

The FDA finalized guidance that outlines recommendations regarding the transition of medical device enforcement policies to normal operations

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FDA Authorizes Marketing of Medasense’s Nociception Monitoring Tech

The FDA granted marketing authorization to Medasense Biometrics’ PMD-200 patient monitor with NOL technology for monitoring nociception.

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FDA Issues Warning Letters to Endoscope Manufacturer Olympus

The U.S. FDA’s Center for Devices and Radiological Health has issued two warning letters to endoscope manufacturer Olympus Medical Systems Corp., following facility inspections.

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FDA Guides Return to Pre-Pandemic Medical Device Enforcement, EUA Policies

The FDA finalized guidance that outlines recommendations regarding the transition of medical device enforcement policies to normal operations

Philips Respironics Ventilators Get New FDA Recall Notice

Dec 29, 2022

The FDA is providing additional information to patients, caregivers, and healthcare providers about two recent issues in certain ventilators.

SURGLASSES Received FDA 510(k) Clearance for Caduceus AR Surgical Solution

Dec 26, 2022

SURGLASSES announced that its Caduceus S AR Spine Navigation System has received 510(k) clearance from the U.S. FDA.

FDA Issues Guidance on Voluntary Malfunction Summary Reporting Program for Device Manufacturers

Dec 12, 2022

The U.S. FDA has issued a draft guidance to help medical device manufacturers further understand and utilize the Voluntary Summary Malfunction Reporting Program.

FDA Clears RF Medical’s Radiofrequency Ablation System

Dec 12, 2022

RF Medical recently received U.S. FDA clearance for its patented MYGEN M-3004 generator and MYOBLA radiofrequency ablation system.

Dexcom’s Continuous Glucose Monitoring System Gets FDA Clearance

Dec 9, 2022

The FDA has cleared Dexcom’s next-generation Dexcom G7 Continuous Glucose Monitoring (CGM) System for people with all types of diabetes.

MediPines Expands Distribution of its Pulmonary Gas Exchange Tech

Dec 2, 2022

MediPines announced that its FDA-cleared, non-invasive pulmonary gas exchange analyzer, the MediPines AGM100, is now available in Canada.

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Lazurite and HSS Collaborate on Developing Wireless Surgical Camera System

Lazurite and Hospital for Special Surgery announced a collaboration based on Lazurite’s ArthroFree Wireless Surgical Camera System.