July 7, 2009 - The U.S. Food and Drug Administration (FDA) has approved Hologic Inc.'s premarket approval (PMA) application for the Adiana permanent contraception system.

The Adiana system is designed to provide women a minimally-invasive, non-incision alternative to traditional, surgical means of permanent contraception. In January 2009, Hologic received CE marking approval for the Adiana system and commenced marketing and sales of this product in certain European countries.

During the Adiana procedure, a slender, flexible instrument is passed through the body’s natural openings to deliver a low level of radiofrequency (RF) energy to a small section of each fallopian tube. A tiny, soft insert, about the size of a grain of rice, is then placed in each fallopian tube in the location where the energy was applied. During the three months following the procedure, the patient continues to use
temporary birth control while new tissue grows in and around the Adiana inserts, eventually blocking the fallopian tubes. At three months, a special X-ray test (called a hysterosalpingogram or HSG) is performed
to confirm the fallopian tubes are completely blocked and the patient may begin relying on Adiana for permanent contraception.

The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the comfort of the doctor’s office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels. There were approximately 70,000 female transcervical contraception procedures performed in the U.S. last year.1

For more information: www.hologic.com


Related Content

News | Breast Imaging

March 10, 2026 — QT Imaging Holdings has received U.S. Food and Drug Administration (FDA) 510(k) clearance for an ...

Time March 13, 2026
arrow
News | Radiology Business

March 12, 2026 — DelveInsight's has released its latest Diagnostic Imaging Equipment Market Insights report. The in ...

Time March 13, 2026
arrow
News | Artificial Intelligence

March 2, 2026 — RadNet, Inc. has acquired Gleamer SAS, a radiology AI company based in Paris, France. Gleamer will be ...

Time March 03, 2026
arrow
News | HIMSS

March 3, 2026 — MedDream will present its cloud-native, AI-ready universal DICOM viewer in the Amazon Web Services (AWS) ...

Time March 03, 2026
arrow
News | FDA

Feb. 26, 2026 — The U.S. Food and Drug Administration (FDA) has given 510(k) class II clearance of qXR-Detect, the ...

Time February 26, 2026
arrow
News | Breast Biopsy Systems

Feb. 18, 2026 — Mammotome, a Danaher company, has introduced the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy ...

Time February 18, 2026
arrow
News | Breast Imaging

Feb. 16, 2026 — Rising demand for breast cancer screening and diagnostics is outpacing the supply of available breast ...

Time February 17, 2026
arrow
News | Magnetic Resonance Imaging (MRI)

Feb. 5, 2026 — Eyas Medical Imaging, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its ...

Time February 06, 2026
arrow
News | Ultrasound Women's Health

Feb. 5, 2026 — BrightHeart, a global provider of AI-driven prenatal ultrasound, has announced the availability of its B ...

Time February 05, 2026
arrow
News | Radiation Therapy

Feb. 4, 2026 — On World Cancer Day (02.04.26), the American Society for Radiation Oncology (ASTRO) and the European ...

Time February 04, 2026
arrow
Subscribe Now