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

May 18, 2011 By MassDevice staff

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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Steris wins second EUA to decontaminate up to 30m respirators per day
Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA… […]
Raumedic supplies adhesive for production of thousands of ventilators
When the federal government tapped Hamilton Medical to produce tens of thousands of ventilators for COVID-19 patients, the company turned to its long-term partner Raumedic for a special silicone adhesive. The adhesive is solvent- and plasticizer-free, easy to use and bonds silicones to each other and to other materials, such as metal or plastics, according… […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories. The… […]
Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure
Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas. The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple… […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do… […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals… […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other.… […]
FDA launches COVID-19 research initiative
The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19. The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using relevant, novel data sources and analyzing these data according to well-established principles.… […]
Medtronic execs see quick recovery, increased M&A
If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies. In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs… […]
Webinar: How COVID-19 is changing medical device regulation, clinical trials and reimbursement
Tuesday, June 23, 2020 11:30 a.m. eastern time / 8:30 a.m. pacific time As the life sciences industry works to contain the COVID-19 outbreak, it is clear that the dynamics of the medical device and digital health industries are being disrupted. Going virtual is the new normal and executives of medtech and healthtech… […]
IMDRF recommends UL 2900 compliance for medical device cybersecurity
By Stewart Eisenhart, Emergo Group Recent guidance published by the International Medical Devices Regulators Forum (IMDRF) that covers medical device cybersecurity best practices includes recommendations that manufacturers comply with the UL 2900 set of standards for network-connectable devices. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post… […]