FDA approves 2 new Allergan breast implants
November 14, 2014 by Val Kennedy
Allergan said the FDA approved 2 new styles of its Natrelle 410 silicone-filled breast implants, the Natrelle X and L.
“The Natrelle 410 X and L styles provide surgeons additional options to customize their patients’ fit by matching the implant’s height and width with the patient’s body type while providing optimal projection, based on the desired aesthetic outcome. The new Natrelle 410 X styles provide extra full projection, while the new L styles feature low height and low projection,” according to a press release. Read more
FDA releases October 2014 510(k) clearances
The Food & Drug Administration releases data on 510(k) clearances for medical devices it approved in October 2014.Read more
Medicrea wins FDA clearance for patient-specific spinal rod
November 13, 2014 by Val Kennedy
Medicrea said it won 510(k) clearance from the FDA for its UNiD device, billed as the world’s 1st patient-specific spinal osteosynthesis rod.
The UNiD system’s software allows surgeons to order rods customized to fit the specific spinal alignment needs of each patient, New York & Lyon, France-based Medicrea said. Surgeons often have to manually contour rods during surgery, which can increase the amount of time patients spend in surgery, according to the company. Read more
New electronic formatting requirements in Canada for Class III and IV MDL applications
November 17, 2014 by MassDevice
Canada’s medical device market regulator Health Canada has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications.
Set to take effect December 1, 2014, the new rules will require Class III and IV MDL applicants to submit premarket review documentation using one of three electronic formatting options: Health Canada’s guidance on supporting evidence, Summary Technical Documentation (STED) or the International Medical Device Regulators Forum’s Table of Contents. Read more
FDA expects China to OK staff visas after 2-year delay
November 17, 2014 by MassDevice
The FDA said last week that it expects China, after almost 2 years of delays, to soon approve visas that will allow the agency to more than double its staff in China.
“We’re heading into the homestretch,” Margaret Hamburg told reporters on a conference call, when asked how soon China might approve the visas, which would more than triple the number of U.S. civil servants it posts in Beijing. Read more
