Before any medical device reaches the market, it has to meet certain safety standards set by the Food and Drug Administration. But these standards are just a first step -- any number of things can happen when the devices hit the clinic.
Erchonia Corporation announces another successful clinical trial that has resulted in the granting of an FDA 510(k) market clearance for chronic low back pain of musculoskeletal origin. This grants another first for Erchonia, which started the low-level laser category in January 2002. That year, the FDA issued its first 510(k) market clearance for any low-level laser based on Erchonia's clinical trial for chronic neck and shoulder pain.
A clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the first Utahns have been treated in its nationwide clinical study of IDCT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).
Sagent Pharmaceuticals, announced the voluntary nationwide recall of Lot Number M813513 of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL). This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of Ketorolac Tromethamine Injection, USP to the to the user level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
The U.S. Food and Drug Administration (FDA) has received reports of serious harm in patients who are physically dependent on opioid pain medicines suddenly having these medicines discontinued or the dose rapidly decreased. These include serious withdrawal symptoms, uncontrolled pain, psychological distress, and suicide.