The FDA issued an administrative order requiring PMA approval for new and existing automated external defibrillators, citing manufacturing issues and pointing to the recall of 2 million of the devices since 2005 as justification for the more stringent regulation.
One week after Johnson & Johnson said that women were being illegally solicited by unknown callers to sue over the company's transvaginal mesh devices, J&J has agreed to settle more than 100 product liability lawsuits regarding pelvic mesh products sold by its Mentor subsidiary.
Dozens of angry patients who claim they were injured by LASIK eye surgeries are banding together in an attempt to pressure the FDA to crack down on providers of the therapy.
C.R. Bard suffered a stinging setback in its ongoing vaginal mesh litigation as a federal judge shot down the company's attempt to push back a product liability trial, rejecting Bard's accusation that the judge's earlier comments regarding a potential settlement may have prejudiced the jury pool.
The FDA slapped Halyard Health's KimVent Microcuff endotracheal tubes with its most severe, Class I recall label, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the agency.
Rumored presidential candidate Sen. Elizabeth Warren (D-MA) wrote a letter to the administrator of the Centers for Medicare & Medicaid Services focused on an issue of great concern to the med tech employee constituency: Unique Device Identification. Co-authored with Sen. Charles Grassley (R-IA), the letter to Administrator Marilyn Tavenner urges CMS to side with various medical associations, think tanks and private insurance companies in support of including UDI information in insurance claims forms.
The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.
The FDA just issued new guidance on the MRI compatibility--or in some cases incompatibility--of implants that do not require electrical power to service their function, such as cardiovascular stents, intracranial aneurysm clips, endovascular grafts and transprostatic tissue retractors.
After recent courtroom losses for Johnson & Johnson and Boston Scientific in cases involving vaginal mesh implants, a federal judge encouraged C.R. Bard to settle the thousands of similar lawsuits it faces. In doing so, he cited the responsibility of the company to its shareholders to limit losses, according to a Bloomberg article.
As the med tech industry casts its eye toward next-generation devices for severe cardiac conditions, physicians are weighing in on the products' efficacy in treating patients with heart failure.