The Amazonification of Boob Jobs…Patients who have their PIPs replaced might also like…
Regulatory
FDA Approves Therapy Cool Path Duo™ Ablation Catheter, Safire BLU Duo™ Ablation Catheter, and Cardiac Ablation Generator.
FDA approves cardiac ablation products from St Jude.
TeDan Surgical Update: MIS Hip Retractor Available In Europe Soon
Update from TeDan surgical on CE status of its new MIS Hip Retractor.
Ex-Eucomed Boss Is New Director Of Medical Devices At MHRA.
At a time when MHRA has never been higher profile, it gets a new boss.
Braile Biomédica Launches Transapical Valve In Brazil
Brazilian developers of the Inovare transapical aortic valve are encouraged by the early experience with the device despite a 50% two-year mortality rate.
Wright’s PROPHECY® INBONE® Pre-Op Guides For Ankle Replacement At AAOS.
Wright’s Prophecy® Inbone® Pre-op navigation alignment guide for ankle replacement surgery has gained 510(k) approval and is being launched on a limited basis in USA.
PIP Scandal: Spot Checks On The Agenda
Lack of unnannounced Spot check provision in Medical Devices Directive seems like and easy fix.
PIP: MHRA Raises Questions About Responsibility Of “Member States”
MHRA counters Financial Times article and “raises questions” about the responsibility of “member states”.
PIP Scandal: EU Scientific Committee Adds Its Voice
European report says we don’t have enough data to conclude PIPs have a greater risk, but the data we do have raises concerns to the extent that health effects can’t be ruled out.
510(k) For Bovie’s Patented J-Plasma™ Technology
Bovie Medical Corporation, has announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market its J-Plasma™ handpiece with retractable cutting feature for soft tissue coagulation during surgery.
CE Mark And Launch For Sorin’s New Pacing, Defibrillation And Left Ventricular Leads
New lead portfolio combined with Sorin Group’s innovative and intelligent devices provide full-featured systems for accurate management of arrhythmias and heart failure
PIP: French Authorities Agree With Medlatest On Spot Checks.
Unannounced spot checks would have given Notified bodies a chance of preventing the PIP scandal. Now French competent authority AFSSAPS signs up to the notion.
Ranier Receives CE Mark Approval for Cadisc™-C Cervical Spinal Disc
Following Ranier’s earlier CE approval of its lumbar implant, the company has now secured CE Mark approval for its cervical implant, Cadisc™-C.
GE Scanner Gains Fully Positive Recommendation From UK’s NICE.
GE Healthcare’s Discovery CT750 HD scanner has been included in the first ever fully positive recommendation from the UK’s National Institute for Health and Clinical Excellence (NICE)’s Diagnostic Assessment Programme, opening the door for increasing use of the technology in Coronary Artery disease assessment.
Now UK NHS Issues Its Own Statement On All Metal Hips.
Following another media flare-up in the ongoing metal-on-metal discussion, NHS has followed UK competent authority the MHRA into releasing a positioning document of its own.
UK MHRA Updates All-Metal Hip Status
UK MHRA updates all-metal hip guidance with statement that most patients are at low risk of developing any serious problems.