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Safer Technologies Program for Medical Devices

In early September, the Food and Drug Administration (FDA) released a draft outlining a new program designed to increase the safety for certain U.S. medical devices. It is a voluntary program that targets current diagnostics and treatments used for mortalities and morbidities that do not qualify for its Breakthrough Devices Program. Called the Safer Technologies » Read More

Understanding Defective Medical Device Claims

Patients trust that the medical products and devices their physicians recommend are safe. While every medical device must undergo extensive testing before it reaches consumers, some are later proven to be defective and even dangerous. Consumers harmed by defective medical devices, such as implants, stents, defibrillators, and other products, may consider bringing a product liability » Read More

Common Mistakes When Injured by a Medical Device

When an individual is injured by a medical device, there are steps they should follow to obtain the best possible legal outcome. Unfortunately, plenty of victims are unsure of what to do after obtaining an injury. This might lead them to make mistakes that hinder the success of their case. Victims are encouraged to consult » Read More

What are Symptoms of Defective Medical Devices?

Use of implantable medical devices has been increasing the chances of survival from several serious ailments. Sometimes, the devices are the only treatment available for a certain condition. The U.S. Food and Drug Administration (FDA) is the Federal agency charged with approving drugs and medical devices. The agency will not approve a medical device unless » Read More

PA Courts to Rule on Strict Liability for Medical Devices

The U.S. Court of Appeals for the Third Circuit was recently asked to determine if strict liability should be extended for prescription medical devices in Pennsylvania. Strict liability holds a party legally responsible for the damages or injuries of another party, even in the absence of negligence or intent to harm. Pennsylvania is not the » Read More

Insulin Pumps Recalled

The Food and Drug Administration (FDA) recently alerted consumers that Medtronic was recalling their MiniMed™ 508 insulin pump and MiniMed™ Paradigm™ Series insulin pump models. They discovered that the pumps were vulnerable to being hacked and could not be updated to correct the issue. The recalled Medtronic pumps could connect wirelessly to equipment, such as monitoring systems and » Read More

What is the Difference Between FDA-Approved and FDA-Cleared Medical Devices?

The types of products that are subject to Food and Drug Administration (FDA) approval are more extensive than one might think. In addition to prescription drugs and foods, the FDA evaluates cosmetics, vaccines, over-the-counter-drugs, infant formula, surgical implants, and medical devices. Although this testing is essential for public health and safety, the system is not » Read More

FDA Ends Program Hiding Reports on Faulty Devices

Roughly 20 years ago, the Food and Drug Administration (FDA) created a controversial program for medical device manufacturers to submit alternative summary reports regarding known risks involving their devices. This program allowed device manufacturers to hide reports from the general public; reports containing information of malfunctions and physical harm. The FDA recently announced that it » Read More

Drug-Coated Stents

When plaque builds up in an artery, it may cause the artery to narrow, which reduces blood flow. This may cause an increased risk of a heart attack. For this, a stent is used to reopen the narrowed artery, reducing the risk of a heart attack. For most people, the placement of a stent results » Read More

FDA Cautions Against Unapproved Tools for Diagnosing Head Injuries

Earlier this month, the U.S. Food and Drug Administration (FDA) warned against using unapproved devices to diagnose concussions and other types of head injuries. In a press release issued on April 10, the FDA cautioned against smartphone and tablet-based applications marketed to coaches, parents, and trainers used to assess changes in brain function. They claim » Read More

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