FDA sends St. Jude a warning over two high-profile device issues
Inspectors with the U.S. Food and Drug Administration on Wednesday slapped St. Jude Medical with a warning letter accusing the medical device maker of failing to properly investigate problems with the batteries in its implantable defibrillators and the cybersecurity of its at-home monitoring equipment.
The inspectors said that company officials systematically underestimated...
EXCLUSIVE: Queens man badly burned in e-cigarette explosion files suit against manufacturers
A Queens man who was severely burned and temporarily had to use a wheelchair when an e-cigarette battery exploded in his pocket is suing the company that distributed the device.
It’s been four months after Otis Gooding’s Wismec Reuleaux RC200 vape instrument blew up while he was at work at the Central...
Medtronic Has A Potentially Deadly Shunt Problem
Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall of all unused units of the StrataMR adjustable valves and shunts.
Roughly 2,622 of the affected devices had been distributed worldwide, and the company said the product’s complaint rate as of April 1 was 2.75%.
Medicare Fee-for-Service Program Improperly Paid $41.1B
Due to problems with oversight and contract issues, the Medicare Fee-for-Service Program wrongly made payments of $41.1 billion in 2016, according to a GAO report.
Following an HHS report that initially found the inappropriate payments in the program, GAO noted that Medicare administrative contractors (MACs) conduct provider education to ensure fee-for-service payments....
USPS agrees to $49 million settlement after having long ‘dawdled’ in payments to beneficiaries
It’s bad enough for family members when a loved one dies.
Getting cheated by Uncle Sam afterward makes it worse.
He did that in cases involving more than 2,000 beneficiaries who didn’t get the full benefit of U.S. Postal Service life insurance policies. After waging a losing fight, the Postal Service surrendered,...
Dr. Salomon Melgen made millions from Medicare, FBI analyst says
While a federal jury is still weeks away from deciding whether Palm Beach County retinal specialist Dr. Salomon Melgen bilked Medicare out of as much as $105 million, they learned on Monday that his far-flung practice was immensely lucrative.
Diagnosing and treating thousands of elderly patients for wet macular degeneration at four...
Engines May Need to Be Replaced in 1.2 Million Hyundai, Kia Cars
Hyundai Motor Co. and Kia Motors Corp. announced recalls to inspect and, if necessary, replace four-cylinder engine assemblies in as many as 1.2 million U.S. vehicles, the South Korean companies said Friday.
Manufacturing errors in Hyundai’s 2.0- and 2.4-liter “Theta” four-cylinder engines, which both companies use in their vehicles, could cause engine...
Does HIPAA need refreshing for the 21st Century? AHIMA wonders
It's been more than two decades since President Bill Clinton signed the Health Insurance Portability and Accountability Act into law in 1996. Since then, the rule has arguably become far more synonymous with its privacy provisions than the health plan flexibility for which it's named.
And 20 years later, its rules –...
Medtronic recalls devices used to manage fluid build-up in the brain
Medtronic Plc said on Thursday it was recalling devices used to manage build-up of the cerebrospinal fluid that surrounds the brain due to increased complaints.
Medtronic's StrataMR adjustable valves and shunts are used in the management of hydrocephalus or 'water on the brain'.
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Amtrak Knew of Flaw That Caused Penn Station Derailment
Two recent train derailments at Pennsylvania Station in New York that created major travel disruptions were caused by track defects, Amtrak officials said on Thursday, increasing concerns about the aging infrastructure at North America’s busiest train station.
Officials also acknowledged that they had been aware of a defect on the tracks at...
