Plastic/Reconstructive

If we want to introduce one measure to prevent a PIP recurrence, it’s the unannounced site audit.

Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”

MHRA comes out fighting “misleading” Lancet

In this editorial we ask whether it’s joined up thinking to claim that the PIP situation, just because it’s a private sector issue, means all private healthcare will be riddled with problems and providers not willing to cooperate on their solution?

Mobihealth News has reported on what may be the first medical app to gain CE Mark approval in the UK.

In a strongly worded press release issued on 9th January, relating to the ongoing scandal relating to PIP breast implants, European medtech industry body Eucomed seeks to make its position clear.

In a press release issued last friday the French Medical Devices Industry Association (SNITEM) is keen to avoid stigmatising French medtech industry controls as being unduly lax, in view of the PIP scandal.

California-based Biomerix Corporation has announced that it has received CE Mark approval for its ASSURE soft tissue repair mesh.

While we can all point fingers at the PIP breast implant situation as being a one-off, all parties must look in the mirror to ensure this is used as a lesson in how things can go wrong.

medlatest speculates about whether regulatory controls are tight enough when a company can substitute “mattress grade” silicone for that which was approved in the regulatory process.

Details of how differing specialties make Medical Device purchase decisions have been quantified in Millennium Research Group’s new Perception Pulse Report

Bacterin International Holdings, Inc. a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, has signed an exclusive agreement with Jeil Medical Corporation for distribution in the U.S. and Canada of Jeil’s LeForte System.

Cohera Medical has announced that it has begun selling its lead product, TissuGlu® Surgical Adhesive, to hospitals and surgeons in three pilot territories in Germany.

Surgeons in Leeds have begun the search for a patient to take part in the UK’s first hand transplant.

Eigr™ Technology Enhances Visibility During Less Invasive Breast Cancer and Reconstructive Surgeries

The UK Government is investing up to £15m to develop specialist prosthetic and rehabilitation centres for military veterans who have lost a limb in service.