Limaca Medical Precision GI Makes Second FDA Milestone
Limaca Medical's Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.
Tag: endoscopy
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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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Endoscope Repair Market to Reach $990.7 Million by 2030
A surge of malignant gastrointestinal, respiratory, and colorectal diseases are some of the factors propelling endoscope market growth.
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Limaca Medical Precision GI Makes Second FDA Milestone
Limaca Medical's Precision GI Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the FDA.
Fujifilm Launches Dual-Channel Endoscope
Fujifilm’s EI-740D/S is a dual-channel endoscope cleared by the U.S. FDA for use in both upper and lower gastrointestinal applications.
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FDA Clears 3NT Medical’s Sinus Endoscope
Short Hills, N.J.-based 3NT Medical announces that the U.S. FDA has cleared its single-use Peregrine Drivable ENT Scope, which is designed to provide ear, nose, and throat surgeons with advanced views of the sinus anatomy.
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Olympus Supports New FDA Guidance on Bronchoscope Reprocessing
Olympus announces that it supports the updated safety recommendations from the U.S. FDA for bronchoscope reprocessing and single-use bronchoscopes.
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FDA Issues Updated Recommendations for Bronchoscope Reprocessing
The U.S. FDA has issued a safety communication providing new recommendations for bronchoscope reprocessing and other new information about bronchoscope medical device adverse event reports.
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OmniVision Launches 8-Megapixel Medical-Grade Image Sensors for Endoscopes
Santa Clara, Calif.-based OmniVision Technologies, Inc. has launched the OH08A and OH08B CMOS image sensors―the first 8 megapixel resolution sensors for single-use and reusable endoscopes.
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FDA Clears EndoFresh Disposable Digestive Endoscopy System
The EndoFresh Disposable Digestive Endoscopy System features a camera system with an all-in-one design, disposable upper GI endoscope, and disposable colonoscope.
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FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes
The U.S. FDA announces that it is investigating numerous medical device reports describing patient infections and other possible contamination issues associated with reprocessing urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes.
