Medtronic to recall diabetes infusion sets
Sept 11 (Reuters) - Medtronic Plc on Monday said that it would recall certain infusion sets used with all its insulin pumps due to a discontinued component.
The company said the component, a vent membrane, in the recalled infusion sets could be blocked by fluid during the process of priming, or removal of air bubbles....
NTSB Staff to Say Tesla Autopilot Should Share Blame for 2016 Crash
Federal accident investigators are poised to find that Tesla Inc.’s auto-driving system should share blame for a fatal 2016 crash in which a Model S sedan drove itself into the side of a truck.
The investigative staff of U.S. National Transportation Safety Board, in its first probe of the wave of autonomous driving systems being...
Key U.S. senators want answers on Equifax’s massive cyberbreach
Two key U.S. senators Monday sought detailed information from Equifax about the cyberbreach that potentially compromised the personal information of 143 million U.S. consumers.
Sen. Orrin Hatch, R-Utah, who chairs the Senate Committee on Finance, and Sen.Ron Wyden, D-Oregon, the panel's ranking minority member, asked the credit-reporting giant for a timeline of the breach, along...
Data of 143 million Americans exposed in hack of credit reporting agency Equifax
The credit reporting agency Equifax said Thursday that hackers gained access to sensitive personal data — Social Security numbers, birth dates and home addresses — for up to 143 million Americans, a major cybersecurity breach at a firm that serves as one of the three major clearinghouses for Americans’ credit histories.
Equifax said the breach...
U.S. FDA warns of problems with EpiPen manufacturing plant
(Reuters) - A U.S. regulator this week told Pfizer Inc’s Meridian Medical Technologies division, maker of the EpiPen injector device, that serious component and product failures have been associated with patient deaths and severe illness.
Tens of thousands of EpiPens, sold by Mylan NV, were recalled worldwide in March following two reports of the life-saving...
EpiPen maker failed to investigate product flaws associated with patient deaths, FDA says
The makers of the EpiPen failed to properly investigate more than 100 complaints that the device malfunctioned during life-threatening emergencies -- including situations in which patients later died, according to a Food and Drug Administration warning letter sent to a Pfizer company.
The FDA said in the letter that Meridian Medical Technologies, a Pfizer company...
Roche Recalls Three Lots of Activase on Sterility Issues
Roche’s Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, which were co-packaged with sterile water for injection, to the hospital level because of sterility issues, according to a Sep. 6, 2017 press release by FDA. The vials of sterile water for injection that were packaged with Activase 100 mg may be...
Equifax reveals hack that likely exposed data of 143 million customers
(Reuters) - Equifax Inc, a provider of consumer credit scores, said on Thursday that personal details of as many as 143 million U.S. consumers were accessed by hackers between mid-May and July, in what could be one of the largest data breaches in the United States.
The company’s shares fell nearly 19 percent in after-market...
Novo Nordisk settles U.S. probe over diabetes drug for nearly $58.7 million
(Reuters) - Novo Nordisk will pay nearly $58.7 million to resolve claims the drugmaker’s sales staff downplayed the importance of U.S. Food and Drug Administration-mandated warnings about the cancer risks of its diabetes medication Victoza.
The U.S. Justice Department said Tuesday’s settlement would resolve claims Novo Nordisk supplied its sales representatives with information to give...
Drug overdose deaths skyrocketed in 2016 — and traditional opioid painkillers weren’t the cause
The federal government just put out new statistics for drug overdose deaths in 2016 — and they are very, very grim.
The preliminary figures from the National Center for Health Statistics suggest that there were more than 64,000 drug overdose deaths in 2016. And in a shocking — but not quite surprising — reveal, synthetic...