Feds Warns Medical Device Manufacturers On Security Practices

By Robert Vamosi | 6/14/13 2:59 AM

New guidelines from the FDA are an attempt to get the healthcare industry to take the necessary steps to prevent various forms of cyber attacks.

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Da Vinci Surgical Robots Probed For Medical Complications

By Robert Vamosi | 3/4/13 7:39 AM

The makers of the da Vinci surgical robots are being probed by the U.S. Food And Drug Administration (FDA) following medical complications after some surgical procedures.

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Embedded Systems You Swallow

By Robert Vamosi | 8/2/12 3:20 AM

The FDA has approved a device that you swallow.

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40,000 Unregulated Health Apps, And Counting

By Robert Vamosi | 7/9/12 2:36 AM

Are healthcare apps written for mobile devices regulated?

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NCCIC Urges Medical Device Security Review

By Robert Vamosi | 6/8/12 1:08 AM

The National Cybersecurity and Communications Integration Center (NCCIC) is urging federal agencies to better monitor medical device security after documented cases of cybersecurity issues.

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New Bi-Partisan Medical Device Legislation Announced

By Robert Vamosi | 3/16/12 2:43 AM

In Washington, Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.) co-authored legislation that would better regulate the fast-growing medical device industry.

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Johnson & Johnson Warned By FDA Over Insulin Pump Failures

By Robert Vamosi | 1/12/12 3:33 AM

In late December, the Food and Drug Administration (FDA) sent the pharmaceutical company Johnson & Johnson a letter warning of possible penalties for not reporting life-threatening vulnerabilities with its OneTouch Ping and 2020 insulin pumps. It is unclear whether the vulnerabilities are outright device failures or from interference or manipulation from outside sources.

After an inspection at Johnson & Johnson's subsidiary plant in West Chester, Pa., the FDA discovered one complaint about series patient injury and two other incidents never reported. According to the FDA one patient was hospitalized with diabetic ketoacidosis, a condition where the body does not have enough insulin. Another received high doses of insulin. And a third patient suffered serious injury, which could include coma, respiratory failure, and hypoglycemia as a result of user error.

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Senators Want Better Medical Device Safety

By Robert Vamosi | 12/19/11 3:46 AM

Three US Senators have introduced a bi-partisan Medical Device Patient Safety Act to stem medical device recalls and shore up existing FDA policy on product approval. Already one medical technology group is opposed.

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FDA Improves Medical Device Data System Requirements

By Robert Vamosi | 6/10/11 3:25 AM

New rules from the US Federal government should improve the security of medical devices and software that store, transfer or display data.

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Wireless Communications Error Causes Medical Device Recall

By JDavis | 10/26/10 12:37 PM

A drug infusion pump manufactured by CareFusion is being recalled due to a wireless communications error that can result in the interruption of drug delivery, which could ultimately result in serious injury or death. Due to the serious nature of the threat posed by this malfunction, the FDA has given the recall Class I status -- reserved for the most critical recalls.

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