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FDA Agrees to UltraShape 510(k) Pathway - Expected to Shorten FDA Clearance Process

UltraShape Ltd. announced today that the US Food and Drug Administration advised the company that it may submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised.

Proceeding under the 510(k) pathway is expected to simplify and shorten the submission process to the FDA for clearance to sell the Company’s Contour I system in the United States.

UltraShape CEO, Assaf Eyal, said “The United States is the largest and most important market in the world, and represents a huge opportunity for our products. Submission for FDA market clearance under the 510(k) regulation is a major milestone for UltraShape. The recent launch of our new third generation product, together with our efforts to gain regulatory approval in the United States and China, provide us with a major growth opportunity.” Read more

               

FDA-Approved Device to Help Surgeons’ Efficiency, Cytori Says

San Diego-based regenerative medicine company Cytori Therapeutics Inc. said Jan. 8 that it received U.S. regulatory clearance to market its PureGraft system, a bedside device capable of removing, purifying and re-injecting a patient’s fat tissue in about 15 minutes.

Shares of Cytori, which have traded between $1.42 and $7.78 in the past 52 weeks, closed up 12 percent at $7.26 that day. The stock is listed under the symbol CYTX on Nasdaq.

Cytori, which has built a business out of tools used for harvesting adult stem cells, said the latest regulatory decision positions it as the only company with an FDA-approved device that can perform cosmetic body contouring procedures using a patient’s own fat.

The company said it will begin marketing PureGraft to plastic and reconstructive surgeons in the United States in the first quarter of the year. It said it will formally introduce the product in April at the American Society for Aesthetic Plastic Surgery’s annual meeting. Read more

               

Laser treatment: Zap those fat cells

No diet, no exercise, no surgery - you can knock off excess weight just by shooting lasers into flabby areas. 

You can get in shape within an hour without diet, exercise or surgery, claimed companies at a show in Dubai.

Exhibitors at the Dubai Congress on Anti-Aging and Aesthetic Medicine (DCAAAM) showed off technology that breaks down fat by shooting sound and pressure waves or lasers into the body’s chubby areas. The destroyed fat cells seep between surrounding tissue spaces and leave the body with sweat and urine, the medical companies explained.

Though full treatments run over a few weeks, results can be seen and felt within the first hour of undergoing the ultrasound or laser sessions, according to the marketing literature of German cosmetic manufacturer Medilab, US medical firm Erchonia and Italian research firm Promoitalia. Read more

               

SPASHAPE© Designing Future in Body Contouring Technology

Available since mid 2009, SPASHAPE© combines Scanning Diodes 635mn laser therapy with Second generation of High Focalised Ultrasounds ( Dynamic HFU).

Based on 7 years experiences in body contouring innovation, such as ULTRACONTOUR, Medixsysteme, France developed a system that proposed two technologies in one platform. The technology is covered by an international patent. Medixsysteme is fully ISO 13485 certified to manufacture medical devices complying with CE norms.

SPASHAPE© is totally non invasive treatment combined able to treat directly the fat cells (in belly, hips and legs regions) and drain the fluids and the waste immediately after in the lymphatic system. Adding the cold laser enhance the results with its proven bio stimulation action. Read more

               

LIPOSONIX System Approved by Health Canada

Medicis Pharmaceutical Corporation today announced that Health Canada has issued a Medical Device License (MDL) authorizing the sale of the LIPOSONIX(TM) System Model 1 in Canada. The LIPOSONIX system is designed to utilize high intensity focused ultrasound energy to reduce subcutaneous abdominal adipose tissue in the treatment zone to provide a non-invasive, non-surgical approach to body contouring. The Company plans for the LIPOSONIX system to be marketed in Canada by Medicis Aesthetics Canada. Read more

               

Guide to Body Contouring Equipment

There are now many new entrants into the Body Contouring equipment realm.   PSP magazine has many of the them compiled in the following online report: Body Contouring: The Major Players.  Here you will see CoolTouch CTEV, Cynosure SmartLipo, Mentor UltraSculpt,  Sound Surgical Technologies Vaser, and Thermage ThermaCoolNXT.  Read more

               

Body Contouring Surgery Risk Rises with Increased Body Mass Index

Study reveals close correlation between degree of obesity and complications arising from popular aesthetic surgical procedure

New York, NY (July 31, 2008) – A recent study investigating the relationship between complications of body contouring surgery and body mass index has confirmed an increase in the occurrence of such complications with worsening degree of obesity.  Findings from the study are published in the July/August 2008 issue of the Aesthetic Surgery Journal, the peer-reviewed publication of the American Society for Aesthetic Plastic Surgery (ASAPS). Read more

               

Medicis to Acquire LipoSonix

Medicis and LipoSonix, Inc. today jointly announced they have entered into a definitive merger agreement under which Medicis will acquire LipoSonix, an independent, privately-held company with a staff of approximately 40 scientists, engineers and clinicians located near Seattle, Washington. As a result of the acquisition, Medicis will broaden its aesthetics portfolio pipeline with LipoSonix’s body contouring technology. This completely non-invasive, focused ultrasound technology is designed to treat troublesome areas of fat which may not respond well to diet or exercise. LipoSonix recently launched its first product in Europe, where it is being marketed and sold through distributors. Subject to approval by the U.S. Food and Drug Administration (FDA), Medicis anticipates entering the potentially lucrative U.S. marketplace with the LipoSonix technology in the 2011 timeframe, if not sooner. Read more

               

New Procedure Threat to Plastic Surgeons, Says a Chicago Physician

Evanston, IL (PRWEB) April 30, 2008 — Plastic surgeons condemn new non-surgical procedure lipodissolve, a safe inexpensive procedure is given a negative spin by plastic surgeons in fear of losing patients says Dr. Bark of the Lipodissolve clinic in Evanston, Illinois.

The two national groups of plastic surgeons have launched their own campaign against a procedure called lipodissolve. Lipodissolve is a non- surgical procedure that any trained and licensed MD can perform. This is potentially taking business away from surgeons who perform liposuction. Patients have become increasingly aware of the inherent risks of liposuction with a death rate of 1 in 5000, mostly due to pulmonary embolism, and are increasingly choosing lipodissolve over liposuction. There have been no deaths or any long-term problems associated with lipodissolve. Read more

               

Liposuction verses Lipo Dissolving Procedures - This Truth Could Save You Money and Your Life

Naples, FL (PRWEB) April 24, 2008 — William O. Murtagh, M.D., a board-certified Naples Cosmetic Surgeon educates patients about dangerous non-surgical alternatives to liposuction. According to the American Society of Plastic Surgeons, liposuction was the most frequently performed cosmetic surgery by ASPS member surgeons in 2004. Those numbers have continued to increase every year, making it evident that the huge demand for body contouring is not likely to go away. Unfortunately, this growing trend has opened the door for companies that are intent on capturing part of this huge market share - companies who target and exploit unsuspecting consumers for profit and put them in harms way. Read more

               

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