Device Safety

Latest Headlines

Latest Headlines

FDA ups regulation of defibrillators to include PMA submission, citing patient safety concerns

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.

J&J settles the score with over 100 vaginal mesh plaintiffs

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.

Aggrieved patients tell FDA to regulate LASIK eye surgery

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.

Bard loses bid to delay vaginal mesh trial proceedings

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.

FDA deems Halyard's recalled KimVent endotracheal tubes potentially deadly

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.

Sen. Warren urges CMS to get on board, encourage UDI info in insurance claims forms

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. 

FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

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.

FDA issues new guidance on MRI safety and compatibility of medical devices

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.

Judge advises Bard to settle vaginal mesh implant cases

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.

Physicians weigh in on ventricular assist devices for treating heart failure

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.