All Articles in: Plastic/Reconstructive
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.
Manufactured by Allergan™, “Gummy Bear” breast implants have been used successfully in Europe and Canada for more than a decade. Now they have been cleared for market in the United States.
Europe’s Most Popular Breast Implant Gets FDA NodFebruary 21, 2013
Allergan’s Natrelle® breast implant line now extends to a newly FDA approved shaped silicone gel option. The implant is already available in Europe and has proven popular, not least because of its anatomical shape.
No More “Fat Hacking” As FDA Clears HydraSolve™ Lipoplasty SystemDecember 18, 2012
A new liposuction cannula that avoids the traumatic sawing action employed during fact removal seems like a good idea. Now it’s gained FDA clearance.
Tummy Tuck TissuGlu® Over First PMA HurdleOctober 31, 2012
Cohera Medical, Inc.®, a leading innovator and developer of absorbable surgical adhesives and sealants, has announced that it has received approval from the U.S. FDA for the first of four modules of the Company’s PMA filing plan for its TissuGlu®Surgical Adhesive product.
AirXpanders Inc., a company developing novel technology for women who require tissue expansion for breast reconstruction following a mastectomy, has received European CE Mark approval for AeroForm™, a needle-free, patient-controlled tissue expansion system.
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