Alongside the FDA, the Federal Trade Commission oversees the marketing and promotion of medical devices. FTC Consumer Education Specialist Aditi Jhaveri took to the agency's blog to warn consumers against purchasing unregulated devices that promote "do-it-yourself" projects, such as weight loss.
The unexpected and unwelcome detection of reduced leaflet mobility in transaortic valve replacements is back in the spotlight thanks to a study of the phenomenon in the New England Journal of Medicine. The paper reveals some tantalizing clues about the technical issue, but it remains mysterious, and the FDA is maintaining its stance that "bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications."
St. Jude Medical revealed in an SEC filing that it has been hit by a FDA warning letter for nonconformance with the agency's Good Manufacturing Practice regulations at the Atlanta facility that makes the CardioMEMS heart failure monitor.
Cogentix Medical has raised a $7 million line of credit from Venture Bank to back sales growth for its disposable endoscope cover EndoSheath as well as its percutaneous tibial nerve stimulation for the office-based treatment of overactive bladder, the Urgent PC Neuromodulation System.
Amid a raft of litigation over vaginal mesh implants, a new study shows that women outfitted with the device often need another operation 10 years after getting the slings for urinary incontinence.
C.R. Bard is facing pushback over one of its blood-clot devices, as reports surface that the company's product caused serious injuries--and in some cases, death--in patients, and that Bard allegedly tried to sweep the problems under the rug.
Infusion pumps are one of the more problematic categories of medical devices with myriad adverse events, including deaths, and recalls associated with the devices. Ivenix expects that its next-gen infusion management system could improve patient safety and workflow efficiency--as well as to adhere to more stringent FDA guidance on infusion systems issued in December.
The FDA recently deemed corrective actions to three devices as Class 1, reserved for situations in which "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Amid growing scrutiny over duodenoscopes' role in spreading potentially lethal bacteria, a California hospital is reporting a suspected superbug outbreak linked to the devices.
As companies such as Boston Scientific, Johnson & Johnson and C.R. Bard continue to face claims over allegedly defective vaginal mesh devices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants.