Device Safety

Latest Headlines

Latest Headlines

Sientra resumes U.S. sales of breast implants after Brazil manufacturing fallout

Sientra is turning over a new leaf. The company will start selling its breast implants again in the U.S. months after issues cropped up at its Brazilian contract manufacturer's plant, prompting it to suspend sales of its devices.

FDA lists difficult-to-use devices that will be subject to human factors validation testing

The FDA just released a draft list of devices whose applications for marketing approval should include human factors data to ensure usability is considered during the design and regulatory process. It also finalized a guidance from 2000, providing updated information on the methods by which companies should collect and submit human factors data.

FDA signs off on 2 of 5 companies producing duodenoscope cleaners

The FDA has now signed off on two out of the 5 manufacturers making automated endoscope reprocessors that are labeled for use with duodenoscopes: Cantel's Medivators and its Advantage Plus and DSD Edge as well as Steris and its System 1E Liquid Chemical Sterilant Processing System.

Olympus, FDA implicated in Senate probe of duodenoscope devices

A group of Senators is coming down on the FDA and manufacturers of duodenoscope devices linked to drug-resistant bacteria outbreaks at U.S. hospitals, revealing results of a probe which found that a leading maker of the products and regulators played down early problems with the devices.

UPDATED: JPM: HeartWare shares plunge 30% as company further delays key CE mark trial

HeartWare shares plunged by nearly 30% on news from its earnings call that the CE mark trial of its MVAD left ventricular assist device will be delayed for at least several months, as the company considers a redesign to improve the safety of the heart failure treatment.

Boston Scientific launches disposable digital urinary tract endoscope

Boston Scientific is rolling out a disposable digital ureteroscope called LithoVue, which is an endoscope specifically designed for minimally invasive means to examine the kidney, ureter and bladder. The device is designed to offer high-quality digital visualization and navigation, but it's for a single use only.

Olympus played down early report of superbug infections linked to duodenoscope devices

Earlier this year, Olympus came under fire after its duodenoscope devices were implicated in superbug outbreaks at medical centers in the U.S. But the company's questionable practices regarding the products date further back, as Olympus played down an early report of a superbug outbreak linked to its device overseas.

Top gynecologists push back at FDA crackdown on power morcellator devices

Last November, the FDA ramped up its oversight of power morcellator devices, recommending against using the tools in most women undergoing a hysterectomy or uterine fibroid removal after finding that the devices may spread hidden cancer in some patients. But not everyone is on board with the agency's move and now some gynecologists are pushing back at its decision, saying that regulators used flawed data to evaluate the device's safety.

Upstart wins CE mark for first swallowable weight-loss gastric balloon

A couple of gastric balloon weight loss products were approved by the FDA earlier this year, greatly expanding the available device options for obese patients. Now, the latest iteration of a gastric balloon has been given the go-ahead in the EU, and it doesn't require endoscopic placement like those already available in the U.S.

FDA warns of 9 deaths due to coatings on minimally invasive intravascular medical devices

The U.S. Food and Drug Administration has issued a safety communication regarding a wide array of intravascular implanted devices and delivery tools that have coatings designed to reduce friction and improve maneuverability.