Hologic wins FDA nod, launches next-gen Omni hysteroscope

Hologic (NSDQ:HOLX) said today that it launched its next-gen Omni hysteroscope in the U.S. after having received FDA 510(k) clearance earlier in the month.

The newly cleared Omni hysteroscope features a three-in-one modular scope and is intended for both diagnostic and therapeutic procedures, the Marlborough, Mass.-based company said.

“Experts agree that direct visualization of the uterine cavity in women with abnormal uterine bleeding is the gold standard that allows physicians to accurately identify and collect quality samples and remove pathology – in a safer and more effective manner than blind biopsy and curettage. Featuring three easily interchangeable sheaths in one scope, our new Omni scope gives physicians excellent visualization capabilities with the convenience of seeing and treating pathology in a more streamlined procedure,” global medical affairs VP & medical director Dr. Edward Evantash said in a prepared statement.

The Omni features the company’s MyoSure optics and sheaths designed for smaller diameters to reduce dilation required, Hologic said. Operative sheaths for the device can also be used with the company’s Fluent fluid management system, and the Omni is compatible with all of the company’s MyoSure tissue removal devices.

“We continue to drive innovation designed with both the user and the patient in mind. Our new Omni scope gives physicians a versatile and economical device to both diagnose and treat, and enhances the patient experience and comfort with a range of size options,” Hologic GYN Surgical Solutions prez Sean Daugherty said in a press release.

In October, Hologic said that it closed the $125 million deal to acquire bioresorbable tissue marker developer Focal Therapeutics yesterday.

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