Medtech manufacturers may soon have clearer guidelines on how to get their products through the FDA’s 510(k) process—with the changes meant to address the widespread criticism of the regulatory pathway in recent years by ...
Interview conducted by April Cashin-Garbutt, BA Hons (Cantab) What is gastric bypass surgery and how many people undergo it? Gastric bypass surgery is a type of bariatric operation that results in weight loss and stimulates metabolic ...
Tags: Interview, gastric bypass surgery, cardiovascular disease
Millions of Americans struggle daily with degenerative, painful and crippling knee or hip arthritis, or similar chronic conditions that can turn the simplest task into an ordeal. Fortunately, for those immobilized by their disease, hope ...
Tags: hip arthritis, knee or hip replacement, crippling knee, OWUSA
After hip replacement, it's important to allow your hip to heal, returning gradually to normal activities. The American Academy of Orthopaedic Surgeons offers these suggestions: Once you're out of the hospital, be sure to get regular ...
Tags: Health Tip, Hip Replacement, Return to Normal Activities
There's no evidence to support the safety or effectiveness of nearly 8 percent of all components used in hip-replacement surgeries in England and Wales, a new study finds. The University of Oxford researchers said the current regulatory ...
The Anapol Schwartz personal injury law firm has announced that a $2.5bn proposed settlement was submitted for the DePuy Orthopaedics Articular surface replacement (ASR) hip implant litigation in a Toledo, Ohio federal court. The ...
Tags: Metal-on-Metal Hip, Medicine
StelKast, a manufacturer and distributor of orthopedic implants for knee replacement and hip replacement, has received 510(k) clearance from the US Food and Drug Administration (FDA) to market EXp for the Proven Gen-Flex total knee system. ...
Tags: Stelkast, Total Knee System
Biomet Orthopedics has announced the first clinical use of its Signature patient-specific glenoid instrumentation in the US, which is designed to improve placement for total and reverse shoulder arthroplasty. The Signature glenoid system ...
Tags: Biomet Orthopedics, Glenoid System
The US FDA has accepted to review Bristol-Myers Squibb Company and Pfizer's Eliquis (apixaban) supplemental new drug application for prophylaxis of deep vein thrombosis (DVT) subsequent to hip or knee replacement surgery. The application ...
Tags: Drug Application, Medicine
The US Food and Drug Administration (FDA) has granted 510(k) clearance to EOS imaging's new sterEOS 3D imaging software. The sterEOS 1.5 software, which is part of the company's full body, low-dose 3 D EOS imaging system, features new ...
Tags: FDA, EOS imaging, 3D imaging software, Drug
Pluristem Therapeutics has gained Paul-Ehrlich-Institute (PEI) approval to begin Phase I/II study for muscle regeneration in Germany. The randomized, double blind, placebo controlled study will assess the safety and efficacy of its PLX ...
Tags: Paul-Ehrlich-Institute, PEI, PLX cells
Janssen Research & Development has submitted a supplemental new drug application (sNDA) with FDA, seeking approval to use Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of stent thrombosis in patients with acute coronary ...