FDA: Hospitals, device makers have roles in cybersecurity

Following a new cybersecurity alert this week from Microsoft, the FDA’s Dr. Suzanne Schwartz is urging medical device manufacturers and hospitals to remain vigilant about protecting their electronic systems.

Schwartz, who is acting director of the U.S. Food and Drug Administration’s Office of Strategic Partnerships and Technology Innovation, said in an emailed statement that manufacturers...

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Supreme Court says Apple can be sued over app prices; Kavanaugh rules

WASHINGTON – The Supreme Court opened the door Monday for iPhone users to sue Apple over excessive prices on its exclusive App Store.

Associate Justice Brett Kavanaugh, the court's newest member, wrote the 5-4 antitrust opinion and was joined by the court's four liberal justices. The other four conservatives dissented.

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80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.

When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.

TESLA MODEL X AUTOPILOT CRASH CAUSES WRONGFUL DEATH LAWSUIT

A Tesla Model X wrongful death lawsuit has been filed by the family of Walter Huang who was killed in a March 2018 crash in Mountain View, California. The lawsuit alleges Huang died because he believed Tesla's advertising about the safety of the Autopilot system and other features.

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After 900% Increase In 2018, Airline Fatalities Rising Again

In 2017, there were a total of 59 deaths attributed to airline accidents. In 2018, there were 561. When I did the math, I was taken aback; deaths attributed to airline accidents had jumped 900% year-over-year. And if present trends are not reversed, it appears that airline deaths will rise further in 2019.

Boeing did not disclose 737 MAX alert issue to FAA for 13 months

Boeing Co (BA.N) did not tell U.S. regulators for more than a year that it inadvertently made an alarm alerting pilots to a mismatch of flight data optional on the 737 MAX, instead of standard as on earlier 737s, but insisted on Sunday the missing display represented no safety risk.

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Plastic surgery device maker draws FDA warning letter

FDA has sent a warning letter to plastic and cosmetic surgery device maker Surgisil instructing the company to cease marketing two lip implant devices not indicated for that purpose, the agency disclosed Tuesday.

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