All Articles in: Plastic/Reconstructive

FDA Nod for Allergan NATRELLE® 410 Silicone Breast Implant Range AddsNovember 13, 2014

Allergan, Inc. has announced that it has received approval from the U.S. FDA to market two new styles, X and L, of the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast reconstruction, augmentation and revision surgery.

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More Evidence Needed Before UK’s NICE will Support Spray-on Skin and Pressure Ulcer-Reducing GarmentsNovember 12, 2014

Two technologies that promise a lot in burns treatment and wound care respectively need more evidence before UK’s NICE will support their adoption.

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FDA Clears Premvia™ Hydrogel Scaffold for Regenerative IndicationsAugust 12, 2014

BioTime, Inc. says its Premvia™ hydrogel tissue substitute has been cleared for marketing as a Class II medical device.

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FDA Clears PicoSure™ for Treatment of Acne ScarsJuly 25, 2014

Cynosure, Inc., has received FDA 510(k) clearance for its flagship PicoSure Picosecond Laser Workstation for the treatment of acne scars.

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EU Launch for KCI Cellutome™ Skin Graft HarvesterJuly 2, 2014

Kinetic Concepts, Inc. has announced the EU launch of its CelluTome™ Epidermal Harvesting System, delivering an automated, precise and reproducible process of harvesting autologous epidermal tissue for grafting.

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FDA denovo Rules Pass Mind-Controlled Robotic ArmMay 12, 2014

The U.S. FDA has cleared for marketing the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.

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Revealing French Breast Implant Report IssuedMay 7, 2014

It’s estimated that 340,000 French women have received silicone gel breast implants in France since their introduction in 2001. Only appropriate then, that the regulators should review the state of play, especially in view of the PIP scandal.

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CE Mark for RTI Surgical’s Fortiva™ Porcine DermisMarch 12, 2014

Pretty much a year after having gained the FDA’s nod for its Fortiva Porcine Dermis Patch, RTI Surgical Inc. has received CE mark approval for the product and says it will begin distribution throughout Europe.

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Good Year for CryoLife with Growth Across BusinessesFebruary 24, 2014

Some outstanding sales figures from tissue sealant, hemostat, vascular and preservation services businesses underpin annual revenue growth of 7 percent.

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Bioprinting Promises 3D Tissue Constructs with Multiple Cell Types and Blood Vessels

Researchers have developed intricately patterned 3D tissue constructs with multiple types of cells and tiny blood vessels. The work could provide tissues that are realistic enough to screen drugs for safety and effectiveness. Ultimately it offers the potential for reconstructive surgery.

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European Varicose Vein Landscape all Lumps and Bumps Says New Study

Varicose Vein treatments typify the adoption of new technologies, factors such as economics, reimbursement and clinical resistance all playing their part in ensuring that the old ways, while in decline, will endure for a while yet.

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New CE Mark Sees World’s First Externally Scannable RFID Breast implantsFebruary 18, 2014

A range of silicone breast implants with integrated RFID technology has been CE Marked. This means key data about the implants can be easily retrieved with the sweep of a scanner, rather than resorting to hospital records in the event of a recall or other clinical need.

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FDA Clears Light-Based Skin Treatment DeviceFebruary 12, 2014

This is the first time we’ve ventured out into the world of aesthetic treatments, with the news that the FDA has given its blessing to a device that exploits the benefits of different forms of light to effect hair removal.

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Shire Takes the Pain and Offloads DERMAGRAFT®January 20, 2014

Global Pharma company Shire plc, is to sell what it calls its “Dermagraft assets” to Organogenesis Inc. for what could add up to $300 million, but for now looks like a $650 million loss.

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British Breast Implant Maker Sizes Up French MarketNovember 28, 2013

A division of GC Aesthetics, Nagor is the only breast implant manufacturer based in Britain. And in a piece of elegant commercial symmetry it has just announced that it is now launching its range in France, no doubt hoping its quality message and reputation will score heavily in the aftermath of a certain other silicone breast manufacturer.

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Final PMA Module Submitted for TissuGlu® Surgical AdhesiveNovember 21, 2013

Surgical Adhesive manufacturer Cohera Medical, Inc.® has submitted its fourth and final FDA PMA module that would ultimately see TissuGlu® indicated for reducing drainage following abdominoplasty procedures in the US.

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