Hologic wins CE Mark for MyoSure Manual

Hologic (NSDQ:HOLX) said today it won CE Mark approval in the European Union for its MyoSure Manual device.

The MyoSure Manual device features an integrated vacuum with no external suction required, the Marlborough, Mass.-based company said. The system is supported by a one-liter bag of saline without the need for a controller or fluid management equipment.

“There is an increased demand to simplify tissue removal procedures regardless of where they are being performed, in-office or in the theater. We continuously look to meet this need by developing innovative solutions that provide flexibility and convenience for both physicians and patients in any setting. The MyoSure Manual device is designed to simplify tissue removal procedures in theatre, ambulatory or outpatient settings, requiring minimal set up and no fluid management capital equipment, while offering direct visualization when used with the MyoSure hysteroscope,” Hologic medical affairs VP Dr. Edward Evantash said in a prepared statement.

The Manual device is part of the company’s complete MyoSure system which is designed for the minimally invasive hysteroscopic treatment of women with problematic tissue which require no cauterization, including the removal of fibroids and polyps which may be the cause of abnormal uterine bleeding.

“The MyoSure Manual device is an exciting addition to our growing portfolio of gynecologic solutions in Europe, all of which have been developed with the patient and physician in mind. This new device expands our MyoSure suite of products, which provide solutions for a wide range of pathologies. It indicates our ongoing commitment to meeting our customers’ needs and improving their patients’ experience by offering solutions that are effective and convenient,” Hologic EMEA & Canada prez Jan Verstreken said in a press release.

Last November, Hologic said it won FDA 510(k) clearance for its Quantra 2.2 breast density assessment software and that it inked a development and distribution deal with Clarius Mobile Health for its wireless, handheld ultrasound scanner.

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