Amid growing scrutiny over duodenoscopes' role in spreading potentially lethal bacteria, a California hospital is reporting a suspected superbug outbreak linked to the devices.
As companies such as Boston Scientific, Johnson & Johnson and C.R. Bard continue to face claims over allegedly defective vaginal mesh devices, new evidence is mounting against an industry that profits off women undergoing surgeries to remove the implants.
Owlet Baby Care has expanded its Series A round by $6 million. It also picked up another $1 million in a National Institutes of Health grant--to bring its fundraising total to $9.2 million. The startup will use that cash for a fall launch of its Owlet Baby Monitor that is intended to alert parents via smartphone if their baby stops breathing.
The FDA has faced its fair share of scrutiny over power morcellators, with the public and advocacy groups claiming that the agency took a backseat in regulating the devices. Now Congress is weighing in on the issue, urging the federal government to investigate the FDA's approval process and monitoring of the tools.
C.R. Bard has settled 3,000 cases by women injured from its vaginal mesh for more than $200 million. This is the latest in a parade of large settlements in recent months over the implants, which are said to cause pain and internal damage, from the likes of Endo International, Medtronic, Boston Scientific and Johnson & Johnson.
The FDA is unveiling its first detailed recommendations for cleaning duodenoscope devices, months after the agency held an expert panel meeting to hash out safety and cleaning procedures for the products.
Duodenoscope devices have drawn the public's ire this past year, with the FDA and patients pushing back against the products in light of superbug outbreaks and mounting safety concerns. Now, healthcare officials are cautioning against a variety of scopes, saying similar devices could lead to potentially deadly infections.
In a strongly worded statement, the FDA told hospitals to stop using Hospira's Symbiq Infusion System because it can be remotely accessed by hackers, allowing the unauthorized user "to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies." The agency's move marks another step to patrol the cybersecurity of medical devices, an issue that has long bedeviled Hospira's infusion pumps in particular.
Last month, the FDA scheduled a September panel meeting to take a hard look at Bayer's controversial birth control device, Essure, after getting complaints of clinical trial fraud and serious side effects tied to the product. Now, the agency is facing more pushback from women campaigning against the device, who claim that regulators purposely selected the panel meeting date to coincide with a visit from the pope.
Amid a growing body of research that shows deposits of gadolinium-based contrast agents (GBCAs) remain in the brain after repeat MRI procedures, the FDA is investigating the products' safety and risks.