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.
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.
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.
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.
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 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.
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.
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.
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.
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.