Cynosure Inc. (NSDQ:CYNO) officials said the company has won international regulatory approval for two of its cellulite reduction systems, including the SmoothShapes laser liposuction device that sucked $40 million out of now-defunct Elemé Medical Inc.
The Westford, Mass.-based cosmetic laser device maker said the SmoothShapes line was cleared for market in Taiwan, while the company’s Cellulaze laser workstation received approval in Australia. The company plans to sell its cellulite-reduction products through independent distributors in both countries.
SmoothShapes and Cellulaze already have CE Mark approval in the European Union, and SmoothShapes is cleared for market in the U.S.
Cynosure acquired SmoothShapes in April when it bought Elemé in an apparent fire sale, writing a check for less than half of the young company’s annual sales. Elemé burned through $40 million in three years trying to launch SmoothShapes, which brought in less than $8 million in sales once it hit the market.
Cynosure wasted no time in broadening its horizons after acquiring Elemé’s assets. In March it touted Canadian approval for SmoothShapes, as well as Korean approval for their Smartlipo Triplex fat-removal system.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies. Check out MassDevice’s compilation of the latest regulatory news for additional clearances and approvals. :
Medtronic Inc.’s (NYSE:MDT) Kyphon balloon kyphoplasty, a procedure that creates an "internal cast" inside the vertebral body, won continued coverage from major Medicare contractor Noridian Administrative Services. Noridian demanded more stringent standards in documentation and pre-procedure patient clinical care. The decision follows the February study that found that kyphoplasty treatment provided cancer patients better back-specific function, more rapid back pain relief and improved quality-of-life compared with non-surgical care one month after treatment.
Small Bone Innovations Inc. boasted Japanese manufacturers’ accreditation for its facilities in Morrisville, Pa. and Péronnas, France. The award is an essential step in developing SBi’s strategic partnership with Tokyo-based Olympus Terumo Biomaterials Corporation to exclusively market small bone & joint implants and instrumentation in Japan.
MEDRAD Inc., a division of Bayer Healthcare (ETR:BAYN), won CE Mark approval from the European Union for its Cotavance drug-eluting balloon for the treatment of peripheral arterial disease .
Silicon Valley-based Asante Solutions Inc., a medical device company focused on diabetes care, announced 510(k) clearance for its Pearl insulin pump. The news comes just a month after the device received CE Mark approval for the European Union.