Hologic wins CE mark for multi-use scope

Hologic (NSDQ:HOLX) said it has received a CE mark for its Omni hysteroscope, a three-in-one modular scope with visualization capabilities designed for both diagnostic and therapeutic hysteroscopic procedures.

The Omni scope is designed to help simplify the process of diagnosing and treating patients, according to the Marlborough, Mass.-based company. Often, a surgeon requires a diagnostic scope to look in the uterine cavity for fibroids or polyps, then switches to an operative scope to biopsy or treat the pathology. The Omni scope enables them use the same scope with different sheath options to see and treat pathology, Hologic said.

Additional features include:

• The company’s MyoSure optics for quality visualization and clarity throughout the procedure.
• Sheaths designed with smaller diameters (3.7 mm diagnostic sheath; 5.5 mm operative sheath; 6 mm operative sheath) to reduce dilation required and promote patient comfort and easy insertion.
• Long 200 mm working length facilitates easier access and treatment for obese patients.
• Simple assembly and disassembly so sheaths can be changed out easily between procedures.
• Operative sheaths can be used with Hologic’s Aquilex hysteroscopic fluid management system.
• Compatible with all MyoSure tissue removal devices.

“Direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows ObGyns to accurately identify and collect quality samples and remove pathology, in a safer and more effective manner than blind biopsy and curettage,” said Hologic medical director and VP of global medical affairs Edward Evantash, M.D., in a prepared statement. Evantash cited a 2011 review of diagnosis and management of endometrial polyps published in the Journal of Minimally Invasive Gynecology.

The Omni scope CE marking was the second in short order for Hologic. Last week, the company announced that its LOCalizer wireless radio frequency identification (RFID) breast lesion localization system had gained the CE mark.  LOCalizer is designed for precise marking and targeting of lesions for breast-conserving surgery guidance and is manufactured by Health Beacons (Concord, Mass.) and is exclusively distributed by Hologic.

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