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Olympus Medical Systems Group

ERCP Stone Management Devices – StoneMasterV and VorticCatchV – Launched by Olympus

ERCP stone management devices include StoneMasterV and VorticCatchV EndoTherapy devices, increasing efficiency in bile duct stone management and retrieval for endoscopic retrograde cholangiopancreatography.

New Colonoscopes Are Launched: Designed to Find More Disease and Improve Treatment Capabilities

Colonoscopes, PCF-H190T and the PCF-HQ190 have received 510 (k) clearance.

Olympus Launches ViziShot 2 25 G Needle

The ViziShot 2 25 G needle, is the smallest gauge size of the Olympus EBUS-TBNA needle portfolio.

Olympus Launches HookKnifeJ and TriangleTipKnifeJ

The HookKnifeJ is for the esophagus, stomach and colon and the TriangleTipKnifeJ is for the esophagus and stomach.

Spiration Valve System Expanded Insurance Coverage; Aetna and Humana Both Cover the Minimally Invasive Spiration® Valve System for Qualified Patients

the Spiration® Valve System, which has been demonstrated to improve quality of life for patients suffering from severe emphysema, a form of COPD

Olympus Launches the Soltive SuperPulsed Thulium Fiber Laser System for Urology

Soltive™ SuperPulsed Laser System is a new application of thulium fiber laser technology designed for stone lithotripsy and soft tissue applications.

iTind Device Receives FDA de Novo Classification Order for Benign Prostatic Hyperplasia: A Non-Surgical Treatment Device

The iTind device was developed by the Israeli-based medical device manufacturer Medi-Tate.

New FDA Guidance and Labeling Changes Affecting PneumoLiner, the Only 510(k)-Cleared Containment Device Reports Olympus

The updated guidance from the Food and Drug Administration mandates that laparoscopic power morcellation in gynecological procedures be conducted with an approved containment device. When taken together with the updated labeling for 510(k) of the PneumoLiner, and an FDA safety update entitled "The FDA recommends performing contained morcellation in women when laparoscopic morcellation is appropriate," the agency is now offering a cohesive and succinct guidance for future use of laparoscopic power morcellation. PneumoLiner, made by Advanced Surgical Concepts (ASC) and exclusively distributed by Olympus, remains the only containment device 510(k)-cleared for use during power morcellation.