Cellulite: Cynosure touts regulatory wins for laser fat-removal products | Regulatory roundup

May 18, 2011 By MassDevice staff Leave a Comment

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’s bone cement gets favorable reimbursement decision
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.

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Japan grants manufacturers’ accreditation to Small Bone Innovations
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.

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CE Mark granted to MEDRAD drug-eluting balloon
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 .

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Asante Pearl insulin pump wins 510(k)
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.

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Mojo Vision developing ‘smart’ contact lens
Mojo Vision is working with the FDA to develop a smart contact lens to help people with low vision. The lens overlays real-time contrast and lighting enhancements with zoom functionality and recently won FDA breakthrough device designation. “Receiving the Breakthrough Device Designation is a significant step in our research and development process. We look forward to… […]
FDA to EPA: Leave us out of your ethylene oxide rule
This article has been updated with comments from the FDA. The FDA has asked the Environmental Protection Agency to leave the FDA out of its proposal for stricter regulation of ethylene oxide (EtO) emissions, and the EPA complied. In an interagency comment on the EPA’s proposed rule governing commercial EtO users — which includes medical… […]
Clippart debuts stepper-controlled flow valve
Clippard recently launched a new stepper-controlled proportional valve for precision flow control. The Eclipse valve uses the industry’s most robust and powerful miniature linear actuator, according to Cincinnati-based Clippard. The patent-pending Eclipse is designed for liquid and gas delivery, medical, analytical and industrial automation requiring ultra-fine resolution and repeatability. The design also allows for custom… […]
Supporting regulatory affairs departments to address clinical requirements under new MDR
By Dietmar Falke and Jaap Laufer, Emergo Group The May 25, 2020 MDR deadline is approaching rapidly, and by now many medical device manufacturers are aware that the MDR requires the proactive collection of post-marketing clinical follow-up (PMCF) data. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog… […]
5 tips to raise funding for your medical device
Securing funding can be a long and tedious process, and medical device businesses must work to position themselves as especially attractive to potential investors to maximize success and accelerate the fundraising process. Jon Speer, Greenlight Guru According to Alejandro Cremades, author of The Art of Startup Fundraising, it can take from six to nine months… […]
FDA recognizes latest ISO 14971 as medical device consensus standard
By Mark Leimbeck and Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted Recognized Consensus Standard status to the third edition of the ISO 14071 risk management standard for medical devices and IVD products. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are… […]
Synaptive Medical updates Modus V surgical microscope
Synaptive Medical announced that its U.S. and Canadian Modus V robotic digital microscope now includes updates such as additional 3D visualization and voice-activated control. The Modus V is a robotically controlled digital microscope used as part of Synaptive’s BrightMatter surgical suite designed for less invasive, patient-specific approaches in complex cranial procedures. The Modus V provides similar… […]
New machine can preserve donor livers for 1 week
Researchers in Switzerland have built a perfusion machine that can preserve human livers for transplantation for a week or more, potentially slashing the number of donor livers that must be discarded due to time-related deterioration. Existing perfusion technology can preserve a donor liver for up to 24 hours. The team of surgeons, biologists and engineers… […]
Smiths Medical launches Portex tracheostomy tubes and kits
Smiths Medical this week launched its Portex polyvinyl chloride tracheostomy tube and kit portfolio. The new polyvinyl chloride (PVC) tube portfolio has options for a variety of patients, according to the company. “Our goal was to create tracheostomy tubes and kits designed to help clinicians provide the best patient care. We’re excited to offer a variety… […]
FDA clears Cleveland Clinic 3D-printed airway stents
The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are… […]
Boston Scientific shares drop on Q4 sales news
Shares in Boston Scientific (NYSE:BSX) dropped 8% this morning on news of disappointing fourth-quarter sales. The company’s preliminary earnings report showed sales for the quarter ended Dec. 31, 2019 coming in at $2.9 billion, below the $2.91 billion that analysts were expecting. The unaudited sales figure represents organic growth of 7.3%, missing the company’s own guidance of… […]