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Home » Olympus launches single-use fine needle biopsy device in US

Olympus launches single-use fine needle biopsy device in US

January 28, 2026 By Sean Whooley

Olympus SecureFlex single-use needle biopsy device
The SecureFlex single-use needle biopsy device. [Images courtesy of Olympus]
Olympus today announced the U.S. launch of its most advanced single-use fine needle biopsy device.

The SecureFlex FNB needle device is used in ultrasound-guided tissue sampling for the diagnosis of diseases like pancreatic cancer. Olympus designed it to enable the collection of large, intact tissue samples. It also provides easy access to difficult-to-reach lesions in areas like the pancreatic head and uncinate process. Olympus offers the SecureFlex needle in 19G, 22G and 25G sizes.

Olympus designed its SecureFlex biopsy device for use with an ultrasound endoscope. It supports endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) of submucosal and extramural lesions within the gastrointestinal tract. The company said its primary clinical application comes in the diagnosis of diseases like pancreatic cancer.

The company first launched the SecureFlex device in Europe and Japan last fall ahead of its latest launch in the U.S.

“Gastroenterologists require precision and reliability when performing a biopsy for diagnostic accuracy. Olympus is excited to offer U.S. customers a dependable biopsy solution designed for precision sampling,” said Christian Hagie, VP, GI EndoTherapy business unit leader, Olympus Corporation of the Americas. “The SecureFlex EUS-FNB needle offers an advanced design to help physicians perform efficient procedures by facilitating access to complex anatomical structures and obtain adequate samples for diagnostic testing, even in challenging cases.”

More about the Olympus SecureFlex biopsy needle

EUS-FNB combines ultrasound and endoscopy to enable physicians to obtain tissue or cell biopsies of lesions from areas like the pancreas that can’t be accessed directly by the endoscope. Olympus says a needle biopsy may be performed through the wall of the gastrointestinal tract with the ultrasound scope inserted orally. This process would use ultrasound imaging for sub-mucosal visualization. It then sends collected tissue samples for pathological evaluation to label a lesion benign or malignant.

Olympus says SecureFlex addresses the need for high-quality tissue sampling. It contributes more to precise treatment planning for pancreatic cancer and other gastrointestinal diseases, the company says.

The device features a dual-beveled raptor tip with multi-dimensional cutting surfaces. It enables the collection of larger, intact tissue samples while preserving cellular architecture through precise tissue execution. This then delivers procedural efficiency. The outer distal cutting surface forms a fine edge to support smooth tissue puncture. Meanwhile, the inner proximal cutting surface minimizes tissue escape.

Olympus said the device’s nitinol construction and multi-layer sheath design also support effective access to complex anatomical structures. With this, it eliminates the need for frequent scope adjustments as well. The system also has houndstooth-patterned dimpling for enhanced ultrasound visibility.

Nitinol innovation: Download our free special report featuring coverage of Adona Medical and other medical device OEMs.

SecureFlex represents part of Olympus’ larger GI portfolio that includes the EU-ME3 ultrasound processor, which supports diagnostic imaging and ultrasound-guided intervention for hepatobiliary-pancreatic procedures and expands the boundaries of endosonography with advanced functions and high-resolution imaging.

Filed Under: Business/Financial News, Endoscopic, Imaging, Oncology, Ultrasound Tagged With: nitinol, Nitinol Devices & Components, Olympus

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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