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BioMimics and Medical Device Testing

Continuous recalls of defective medical devices have prompted new research in medical device testing. To improve the quality and safety of medical devices, the 3D printing company, Stratasys, has designed a new tool for device testing. BioMimics consists of fully functional, 3D printed models that replicate the human body. Instead of turning to animals, mannequins, » Read More

First Digital Pill to Track Patient Medication

The Food and Drug Administration has approved a digital pill capable of tracking whether patients are taking their medication. The pill, which will become available to patients in 2018, includes a minute digital sensor that records when patients take the drug. Currently, the approval is strictly for Abilify MyCite, a medication approved for schizophrenia or » Read More

Recall of Johnson and Johnson Valve Replacements

The Food and Drug Administration (FDA) started 2018 with a Class 1 recall of heart valve replacement devices. A Class 1 recall is the highest level of recall issued by the FDA. It is issued when there is a reasonable probability that a device could cause serious health issues, including death. Cost of Device Failure » Read More

Heart Stents Fail to Ease Chest Pain

Since Robert A. Ersek, M.D. patented the first heart stent in 1972, the procedure has become a common practice in hospitals around the world. Hundreds of thousands of patients annually undergo a surgical procedure that includes inserting a stent into an artery. However, new research indicates that some of these patients may have undergone this » Read More

Reducing the Risk of Medical Device Recalls

Reducing the risk of medical device recalls might be as simple as increasing the rotations of FDA plant inspectors. This was the key finding from a study that sampled seven years of data from FDA inspections and recalls. If the FDA decides to implement the findings, researchers believe it will lead to higher quality facilities » Read More

Medtronic Diabetes Insulin Infusion Pump Recall

Medtronic announced a voluntary recall of its diabetes insulin infusion pump last September after patient field reports alerted the manufacturer of a problem. Medtronic determined that a discontinued component within the device was causing the pumps to oversupply insulin. An overabundance of insulin can result in hypoglycemia and can prove fatal. Medtronic issued a voluntary » Read More

Meridian EpiPen Issues Recall

The last few years have not been good to people with severe food and insect allergies. Many people with severe allergies rely on epinephrine injector pens to save their lives in cases of emergency but there are only a few manufacturers of these pens. Recalls and price hikes have placed allergy sufferers in a precarious » Read More

Medical Device Recall Rates Depend on Inspection Rotations

Research conducted by a team from Indiana University, University of Wisconsin, and University of Minnesota considered the impact of inspection rotations on recalls. The team looked at seven years of data in conducting the study, examining medical device recalls from over two thousand U.S. manufacturers. The research team sought to understand the impact of regulatory » Read More

Potential Risks in New Olympus Power Morcellator Study

In 1995, the Food and Drug Administration approved the laparoscopic power morcellator, a tool for OB/GYN surgeons to use in the removal of uterine fibroids. After Dr. Amy Reed of Philadelphia underwent a hysterectomy in 2013, she developed a uterine sarcoma. She and her husband, Dr. Hooman Noorchashm, discovered fabricated studies and increased cancer risks » Read More

Maquet Intra-Aortic Balloon Pump (IABP) Recall

New Jersey-based Datascope Corporation has issued a voluntary recall of the Maquet Intra-Aortic Balloon Pump System 98/98XT. The U.S. Food and Drug Administration officially issued the Class I recall on June 16, 2017. The defective medical device affects 9,194 patients in the United States. The company, located in Wayne, New Jersey, entered the recall after » Read More

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