All Articles in: Plastic/Reconstructive
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.
Future Looking Bright for Invuity® as Eigr™Illumination Technology Showcases at Anterior Hip Course and Novation ExpoOctober 4, 2013
It seems San Francisco’s Invuity, Inc., has hit on a rich vein of unmet need as its clever illuminated retractor systems featured heavily in the last two weeks at both an anterior hip arthroplasty course and an innovation technology showcase hosted by one of the big healthcare supply chain companies.
FDA Clears Syneron Medical’s New VelaShape® III Platform for Abdominal Circumferential Reduction…CE Mark Too!September 11, 2013
Aesthetic medical device company Syneron Medical Ltd., has announced FDA clearance and CE mark approval for VelaShape® III, the Company’s new non-invasive body shaping platform. This new platform is said to be effective for temporary reduction in circumference of the abdomen and is also used in a wide range of other body shaping applications such as cellulite treatments.
Potential for Excellagen in Repair of Prenatally Diagnosed Birth Defects Using Mesenchymal Stem CellsAugust 13, 2013
Cardium Therapeutics has reported on a research collaboration with researchers at Boston Children’s Hospital, to assess the medical utility of Excellagen® as a delivery scaffold to seed autologous mesenchymal fetal stem cells for ex-vivo engineering of tissue grafts for transplantation into infants to repair prenatally diagnosed birth defects.
FDA Nod For MENTOR® MemoryShape™ Breast ImplantsJune 18, 2013
Aesthetic Breast expert Mentor Worldwide LLC, has announced the U.S. FDA approval of its MENTOR® MemoryShape™ Breast Implants, providing new options for women looking for a more natural shape and youthful feel from breast enhancement or reconstruction surgery.
Implant company RTI Biologics Inc. has launched its Fortiva™ porcine dermis implant at the Abdominal Wall Reconstruction (AWR) Conference in Washington, D.C., June 6-8. RTI claims this implant positions it as the only provider with a comprehensive biologic solutions portfolio …
When Sweden’s device authority called for all PIPs to be removed last week their evidence was seized upon by UK plastic surgeons in the form of their specialty body, the British Association for Aesthetic Plastic Surgeons (BAAPS) which is now …
TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific claims of clinical benefits from use of SurgiMend® PRS in breast reconstruction following mastectomy for breast cancer. Background The approved …
Swedish Regulators Want All PIPs OutJune 5, 2013
According to a release from the UK’s MHRA, its Swedish equivalent has adopted the position that PI implants should be removed as a precautionary measure. The MHRA has issued its own statement reasserting its position that this is not necessary in all cases.
No PIP Verdict Until December 10!May 17, 2013
Somehow the idea that using an illicit material in a bodily implant is now OK, regardless of whether it’s approved. So claim the defendants in the PIP case which has seen its closing remarks today. This cavalier approach is what got PIP into hot water, but they seem to be in a state of denial that they’ve done much wrong at all.
Last Days Of PIP TrialMay 16, 2013
So we’re nearly there. The trial of PIP boss Monsieur Mas is at the stage of final remarks and prosecutors are calling for a sentence amounting to four years in jail for a variety of offences including aggravated financial fraud. …
Parametrics Medical, LLC, a private tissue bank has announced its release of its Coll-e-Strong line of soft tissue allografts. Using E-Beam Technology, to terminally sterilize the tissue without compromising the biomechanical properties of the collagen, the company claims its allograft line is the first to bridge the gap between biomechanics and sterility.
HydraSolve Harvested Fat Now FDA Cleared For ReinjectionApril 24, 2013
It’s a form of ultimate recycling, fat tissue removed using Andrew Technologies’ HydraSolve device now being FDA cleared for reinjection into the same patient.
Weekly Medtech News Editorial Online NowApril 19, 2013
Two main court cases attracted our interest this week. While the situations contrast, the common thread of patient suffering runs through both cases.
PIP Implant Trial StartsApril 17, 2013
Jean-Claude Mas and his allegedly comspiratorial team from PIP start their trial today, facing charges of aggravated fraud in France’s biggest legal proceedings.
Posted in: Plastic/Reconstructive
Tenex Health’s TX1 is a clever ultrasonic device can cut and debride damaged tendon without affecting the surrounding healthy tissue. Now FDA has expanded its indications with a new 510(k) clearance that enables the company to press on with its pipeline of applications.
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