Hospira is back in the FDA's spotlight as the agency issued another warning letter over problems in the company's infusion pump manufacturing, this time targeting the device Hospira hopes to carry it back to revenue growth.
Hip and knee implant makers, take note: Researchers have come up with a blood diagnostic test that detects allergies to nickel, a metal commonly used in those products.
The FDA has been inspecting more and more medical device manufacturers over the past 5 years, and that's resulted in an 8-year peak in warning letters issued, according to a study.
St. Jude Medical's much-scrutinized defibrillator leads remained almost 100% safe from abrasion and mechanical failure after 5 years, according to an independent analysis, results the company hopes will quiet alarm from regulators and competitors.
A top U.K. health regulator's report last year concluding Poly Implant Prosthese's (PIP) substandard breast implants didn't pose long-term health risks to women who had them likely caused some to breathe a sigh of relief. But two leading scientists are now questioning the finding.
Thieves heisted a lot of Covidien's surgical stapler reloads before they were sterilized, and the FDA said the criminals have put the devices up for sale, possibly putting patients in danger of infection after surgery.
Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.
In what could be a deathblow for Delcath Systems, an FDA panel of experts voted unanimously that the risks of the company's drug-device combo to treat cancer outweighed any benefits.
Last month, Covidien launched a recall of battery packs used with its Newport HT70 ventilators, and now the FDA has assigned its most serious designation to the problem, warning that the malfunctioning batteries could lead to injury or death.
After a year of recalls, bans and technical failures, Hospira is changing the way it does business in medical devices, planning to discontinue some of its infusion pumps and focus on next-generation technology.