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24th October to 30th October

October 24th: BioLucent Receives FDA Clearance for SAVI, a New Breast Brachytherapy Device

BioLucent, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its SAVI(TM) applicator. The SAVI device offers a multi-catheter, single-entry approach to breast brachytherapy, a procedure that helps treat cancer through radiation sources placed inside the breast.

SAVI combines the tissue-sparing dosimetry of interstitial brachytherapy with the single-entry ease of intracavitary ("balloon") brachytherapy. This new hybrid approach is designed to give more flexibility in treatment planning to the radiation oncologist and physicist.

The applicator is for use in accelerated partial breast irradiation (APBI) treatment following a lumpectomy. The device includes an expandable bundle of catheters that surround a central lumen. The applicator is placed by the physician into the lumpectomy cavity through a small incision.

The physician expands the catheter bundle by turning a mechanism from outside the breast. The catheters expand to form an ellipsoidal shape inside the cavity. Delivery of radiation through the device's individual catheters allows the doctor to better contour and control the radiation dose.

More precise delivery of radiation may help avoid radiation damage to the skin or chest wall that can occur with other breast brachytherapy procedures, and may also make the benefits of accelerated partial breast irradiation accessible to a larger group of women.

APBI was developed as an alternative to whole-breast irradiation. Both whole-breast irradiation and APBI are used after lumpectomy to help prevent local recurrence of breast cancer.

The course of treatment for whole-breast irradiation is five to seven weeks, with five treatments per week. According to research, this lengthy treatment period prompts some women to opt for complete removal of the breast, rather than a breast-sparing lumpectomy procedure with whole-breast irradiation.

With APBI, treatment lasts one week or less. Other potential advantages of APBI include improved access to radiation therapy facilities, lower risk of injury to healthy tissue, and a faster transition to chemotherapy.

SAVI was developed by BioLucent, Inc., the women's health company dedicated to early detection and treatment of breast cancer.

October 25th: FDA Approves New Medical Device for Elderly, Disabled and Bedridden

The FDA approved this month a new medical device that - for the first time in nearly a century - gives new hope to the disabled, elderly, hospital patients and others with limited mobility who suffer from urge or functional incontinence. "UrAssist" is a new non-invasive, portable and pump-assisted urine collection and containment system that can prevent embarrassing accidents, while also potentially reducing the risks of sores, rashes, urinary tract infections and slip-and- fall accidents.

UrAssist may reduce costs at hospitals and long-term care facilities by potentially lowering the risk of patient urinary tract infections and reducing staff workloads.

UrAssist is about the size of a laptop computer and weighs less than five pounds when empty. It can be attached to most wheelchairs, scooters and bedsides.

The device is battery-operated and uses a patented pump-assisted technology to quietly draw urine from a collection cup through a plastic tube into a collection bag that stores a day's amount of urine. This bag is securely stored within the unit - and audio and visual alarms alert users once the bag is full. UrAssist requires only periodic rinsing and replacement of the collection cup, tube and containment bag. The rechargeable battery lasts up to two weeks.

In addition to being easy to use, UrAssist may also make patients safer:

- Slip-and-fall accidents: UrAssist can be attached to the bed, which means elderly patients don't have to get up at night to go the bathroom, reducing their risk of slip-and-fall accidents.

- Urinary Tract Infections: Because UrAssist is a non-invasive system, it may lower the risk for UTIs.

- Sores, rashes: UrAssist's design prevents spills and moisture build-up, potentially reducing the risk of sores and rashes that can occur with other incontinence aides.

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