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medical device 90 articles

Number of drug side effects reports skyrocketing in recent years

The Food and Drug Administration (FDA) received a record number of adverse event reports about drug side effects and problematic medical devices for 2015, representing a fivefold increase since 2004, according to an analysis by the Milwaukee Journal Sentinel and MedPage Today. In 2004, 206,000 drug or medical device adverse events were reported to the FDA. In 2015, that number jumped to 1.5 million. Reports ranged from mild effects such as gas and flatulence to serious injuries and death. Most of the side effects reported involved drugs that treat diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, a type of cancer, and ... Read More

German medical device maker answers FDA regarding adverse event reporting

When consumers or doctors complain to medical device manufacturers about the malfunctioning of a device that could potentially lead to an injury, the company is required to report the issue to the Food and Drug Administration (FDA) within 30 days. This way, if the agency spots a trend, action – such as a recall – can be taken to protect future patients from being harmed. Medical device company Biotronik SE & Co., based in Berlin, Germany, failed to do this and, as a result, was slapped with a warning letter by the FDA on Sept. 1, 2016. The letter pointed ... Read More

Cybersecurity in medical devices: FDA addresses device manufacturers in updated guidance

As more cybersecurity concerns continue to threaten our country, the U.S. Food and Drug Administration (FDA) has updated its guidance on how medical device makers can ensure their approved products are safe from cyberattacks and report any post-approval fixes. According to Law360, the FDA’s announcement adds to a prior document highlighting the dangers associated with medical device software. The agency also held a public workshop Jan. 20-21 at its Silver Spring, Md., campus to discuss how different sectors can work together and reduce risks with Internet-connected medical devices. The FDA is emphasizing the importance of post-approval vigilance due to the growing tactics used by ... Read More

Medical device maker ev3 pays $1.25 million to settle whistleblower’s False Claims Act lawsuit

Medical device manufacturer ev3, formerly known as Fox Hollow Technologies Inc., has agreed to pay the U.S. government $1.25 million to settle a whistleblower’s allegations that the company encouraged hospitals to admit patients for procedures involving its devices as inpatients when they should have been treated as outpatients at a significantly lower cost. The Justice Department said the scheme resulted in the hospitals submitting false claims to Medicare. According to whistleblower Amanda Cashi, a former sales representative for Fox Hollow Technologies, the company intentionally caused 12 hospitals in nine states to submit claims to Medicare for medically unnecessary inpatient stays. Patients ... Read More

Most health-related mobile apps do not require FDA oversight

More than 30,000 health-related mobile apps are on the market – from thermometers to stethoscopes – designed to empower consumers to take a more active role in managing their health. But how can these devices be regulated to ensure safety and efficacy, while not stifling innovation? This question has come up in the House and Senate, both of which have introduced bills in the past year calling for Food and Drug Administration (FDA) oversight for apps that pose a potential risk to consumers, while limiting regulatory authority for low-risk applications. Literally thousands of mobile health apps are available in Apple ... Read More

More government oversight credited for jump in medical device recalls

The number of medical device recalls has doubled in the past 10 years, according to a new report, a result of more government oversight and manufacturers doing a better job of halting sales of defective devices, officials say. Yearly recalls jumped from about 600 in 2003 to 1,200 in 2012, according to the report, which was prompted in 2011 by the Government Accountability Office (GAO). The largest rise was due to radiological devices, such as MRI and CT scanners, which have been found to register false positives and increase the risk of cancer. A fifth of the recalls in 2012 ... Read More

FDA approves medical device to treat migraine headaches

The Food and Drug Administration (FDA) has approved a novel new nerve-stimulating headband designed to treat and prevent migraine headaches. The device offers a new option for migraine sufferers who cannot tolerate migraine medications. The Cefaly device is a battery-powered plastic headband that is worn across the forehead. The band emits a low electrical current through an adhesive electrode to help stimulate nerves that trigger migraines. The headband is designed to be worn for up to 20 minutes a day in adult patients age 18 and older. The device was approved based on a 67-person study that showed those using ... Read More

Google develops contact lens aimed at replacing blood glucose monitors

Could contact lenses replace finger-pricking to measure blood sugar levels? Google is banking on the possibility. The company earlier this month unveiled a prototype of a wearable smart device, a soft contact lens that can measure the amount of sugar in tears. The special contact lens has a tiny pinhole that lets tear fluid seep in and pass over a sensor that acts as a glucose monitor. The lens currently can get a level reading once every second. A small antenna, capacitor and controller allows the information gathered to be transferred to a handheld device for reading. More than 25 ... Read More

FDA proposes new guidelines for approving diabetic blood glucose monitors

Federal regulators are proposing guidelines for approving diabetic blood glucose testing monitors to help distinguish between monitors sold over the counter and ones intended for professional use. The approval recommendations were made because, the Food and Drug Administration (FDA) said, the different types of devices pose different risks depending on whether they are used at home or in a medical setting. Blood glucose monitors designed for self-use should be easier to use and understand than those designed for use by medical professionals, the agency said. For example, patients are less likely to have the expertise or health to properly used more ... Read More

Stryker to pay up to $1.1 billion to resolve metal hip lawsuits

Medical device maker Stryker Corp. says it expects to pay up to $1.1 billion to settle personal injury lawsuits stemming from a 2012 recall of two of the company’s metal hip implants. The amount is more than twice what the company previously estimated it would have to pay to resolve the lawsuits. In July 2012, Stryker recalled its Rejuvenate and ABG II modular-neck stems because of concerns that the devices could fret or corrode inside the body, which could damage surrounding tissue and cause pain and inflammation. Last July the company in a securities filing said it estimated the costs ... Read More