EU lawmakers back strict new approval system for medical devices

By Charlie Dunmore

BRUSSELS | Fri Sep 27, 2013 12:16pm EDT

BRUSSELS (Reuters) - European Union lawmakers backed a strict new approval system for high-tech medical devices on Wednesday, raising industry fears of added delays in getting new products to market that could dull Europe's competitive edge.

Members of the European Parliament's environment committee voted in favor of a new pre-market authorization system of randomized clinical trials for implantable devices, covering everything from hip replacements to artificial heart valves.

Moves to tighten the rules followed a 2011 scandal involving France's now defunct Poly Implant Prothese (PIP), which for up to a decade made substandard breast implants with industrial-grade silicone that were used by hundreds of thousands of women around the world.

Some critics said the scandal was the result of Europe's current authorization system, which is less strict than in the United States where extensive testing is required before new products are approved for sale.

In response, the EU's executive - the European Commission - has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety.

But Wednesday's committee vote went far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing assessment system for high-risk devices, which would be identified on a case-by-case basis and only authorized with the approval of the European Commission.

Europe's 100 billion euro ($135 billion) medtech industry has said that would add years to the time it takes to bring new devices to market, removing a key advantage that EU companies enjoy over their U.S. rivals.

"The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers," EU trade group Eucomed said in a statement.

The body also questions whether the EMA will have the capacity to evaluate the 400 to 600 so-called "Class III", or high-risk, devices that currently reach the market each year in Europe.

Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.

Reflecting the deep divisions on the issue, Wednesday's parliamentary vote followed more than 900 amendments by lawmakers to the Commission's original proposal.

If the committee's stance is confirmed by the full parliament in the coming weeks, it will form the basis of the assembly's negotiating position in subsequent talks with EU governments to finalize the rules.

(This correction corrects paragraph 6 to remove reference to European Medicines Agency)

(Editing by Ben Hirschler and Anthony Barker)

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EU lawmakers back strict new approval system for medical devices

By Charlie Dunmore

BRUSSELS | Wed Sep 25, 2013 11:05am EDT

BRUSSELS (Reuters) - European Union lawmakers backed a strict new approval system for high-tech medical devices on Wednesday, raising industry fears of added delays in getting new products to market that could dull Europe's competitive edge.

Members of the European Parliament's environment committee voted in favor of a new pre-market authorisation system of randomized clinical trials for implantable devices, covering everything from hip replacements to artificial heart valves.

Moves to tighten the rules followed a 2011 scandal involving France's now defunct Poly Implant Prothese (PIP), which for up to a decade made substandard breast implants with industrial-grade silicone that were used by hundreds of thousands of women around the world.

Some critics said the scandal was the result of Europe's current authorisation system, which is less strict than in the United States where extensive testing is required before new products are approved for sale.

In response, the EU's executive - the European Commission - has proposed increased monitoring of device manufacturers and tougher government oversight of the 80 or so mostly private Notified Bodies that currently decide on product safety.

But Wednesday's committee vote went far beyond the Commission's original proposals, calling for the establishment of a new pre-marketing authorisation system for high-risk devices under the control of the European Medicines Agency (EMA).

Europe's 100 billion euro ($135 billion) medtech industry has said that would add years to the time it takes to bring new devices to market, removing a key advantage that EU companies enjoy over their U.S. rivals.

"The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers," EU trade group Eucomed said in a statement.

The body also questions whether the EMA will have the capacity to evaluate the 400 to 600 so-called "Class III", or high-risk, devices that currently reach the market each year in Europe.

Major makers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott, Allergan and Smith & Nephew.

Reflecting the deep divisions on the issue, Wednesday's parliamentary vote followed more than 900 amendments by lawmakers to the Commission's original proposal.

If the committee's stance is confirmed by the full parliament in the coming weeks, it will form the basis of the assembly's negotiating position in subsequent talks with EU governments to finalize the rules.

(Editing by Ben Hirschler)

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McAfee Launches LiveSafe Cloud Security For PCs, Macs & Mobile Devices

McAfee today launched LiveSafe, a new cloud-enabled, crossplatform security service for PCs, Macs, and mobile devices, with extra identification and anti-theft features for Ultrabook notebook PC users. McAfee LiveSafe will start shipping on Ultrabooks from Dell on June 9, before hitting retail stores as a packaged product in July.

With the new LiveSafe, McAfee is stepping further beyond traditional "thick client" security software into the cloud-based scenario already embarked upon with McAfee All Access, said Gary Baker, McAfee's VP of global consumer marketing, in a briefing and demo for NotebookReview in New York City.

For an annual subscription fee, users will receive security services for unlimited numbers of Windows PCs (XP through Windows 8), Macs, and mobile devices. Although features vary according to device, McAfee is supporting Android, iOS, BlackBerry, and Kindle Fire platforms.

Some 60 percent of consumers world own three or more Internet-enabled devices, according to McAfee's 2013 Digital Assets Survey, also released today. Davis also pointed to projections from Gartner of 203 million tablet shipments this year and 9.6% growth in the mobile phone market.

Specific services of McAfee LiveSafe include McAfee Personal Locker, McAfee SafeKey, and McAfee Anti-Theft, he said.

Some of the features available for PCs and Macs have become standard in McAfee software. These include antivirus, antispyware, and antiphishing protection; a two-way firewall; parental controls, and Web site ratings.

For smartphones and tablets, features of LiveSafe include antivirus safeguards, "locate, lock and wipe," data backup and restore, Web and app protection (Android only), and call and SMS filtering (Android and BlackBerry).

New Personal Locker Service

Through the new McAfee Personal Locker services, users can obtain encrypted storage for up to 1GB of highly sensitive documents, accessing the docs through a combination of face recognition, voice recognition, and PIN.

In a demo, Davis showed how you can access a doc from an iPhone. After you successfully enter a PIN, LiveSafe uses both face and voice recognition, amounting to three-factor authentication. LiveSafe asks you to read aloud randomly selected text passages to authenticate your voice. If your face or your voice is not a match for the biometic data enrolled in the system, you won't get in.

McAfee SafeKey, a feature first introduced in McAfee All Access, is designed to securely manage passwords and user names while also storing sensitive information like bank and credit card account numbers. In LiveSafe, it supports PCs, Macs, iOS, Android, and the Kindle Fire.

McAfee Anti-Theft offers capabilities for remotely locking and disabling devices, locating devices, and automatically encrypting and recovering data.

McAfee LiveSafe also takes advantage of antitheft and identity protection technologies built into 4th generation Intel core processors found in current Ultrabook models. "McAfee Anti-Theft works with all the Intel devices which support this technology. It is possible that a non-Ultrabook may support this technology [and] therefore McAfee Anti-Theft will work. McAfee Anti-Theft uses hardware features supported by Ultrabook," explained Yogesh Jain, group product manager at McAfee.

For multi-factor authentication, McAfee has combined Intel's IPT (Identification Protection Technology), a tamper-resistant hardware authentication mechanism, with face and voice recognition.

Users can also enroll their biometric credentials from an iOS or Android device, or from a non-Ultrabook device, "but in this case they need to provide PIN details," said Jain.

LiveSafe On the Way to All Ultrabooks, And As Packaged Product

Although Ultrabooks from Dell will be the first to ship with LifeSafe aboard, McAfee plans to gradually roll out the technology to Ultrabooks from all major manufacturers -- including Acer, Lenovo, Asus, Toshiba, and Fujitsu, for example -- by the end of this year, Davis told NotebookReview. "This will be an OEM by OEM decision," he elaborated.

McAfee, an Intel-owned software company, will co-merchandise LiveSafe with Intel through an "awareness program" in retail stores.

LiveSafe will also be available as a packaged product for $19.99 for a 12-month subscription when purchased with a new PC or tablet and $79.99 for a 12-month subscription for an existing PC or tablet.

The package sold at retail, though, will include an activation key only, without a CD, Davis said.

McAfee does not plan to sell LiveSafe direct over the Web, as it does with McAfee All Access, he told NotebookReview.

At some point, though, McAfee will probably "converge" the two products, he said.

All LiveSafe users will receive free technical support. Ultrabook users, though, will also be entitled to Premium Support. "McAfee LiveSafe customers receive free support for the life of their subscription. Support is delivered via phone, chat, email and online FAQs," said Jain. Premium support, on the other hand, "includes McAfee Security Advisor service, which offers Ultrabook users the added benefit of immediate answers to all of their security questions."

Davis told NotebookReview that McAfee has no plans at this time to integrate technology from Stonesoft into its long-time two-way firewall.

McAfee acquired firewall technology specialist Stonesoft last week. However, the acquisition was "more of a B2B play" aimed at buttressing McAfee's enterprise security products, Davis said.

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AT&T now offering trade-in discounts on new devices

AT&T is extending an offer from any of its retail locations that will give customers who trade-in an old smart phone at least $100 towards a new phone of their choice on the network. As long as the phone you are trading in is no more than 3 years old, and is in good working condition, you'll receive an instant credit of $100 or more to put towards a new device. AT&T says that each device will be evaluated, and some could be worth more than $100 as well. The credit can be applied towards brand new devices like the Samsung Galaxy S4 and HTC One, or lower-end devices as well.

While some authorized retailers may participate in the trade-in program, corporate AT&T stores are guaranteed to participate and may accept a wider range of devices, including tablets, data sticks and even feature phones. The offer seems like a pretty good deal for those trying to make an upgrade and save an easy few dollars, and could bring your on-contract price for a new device near $0 if you're lucky.

Source: AT&T

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iPad Black Capacitive Stylus (2-Pack) - works with iPad, Hp TouchPad, iPhone 4/4S and all capacitive Touch screen Devices

These are Universal Touch Screen Stylus Pens for Apple iPod, iPad, iPhone. Clip design to make them easy to carry, just clip them in your pocket, book, diary, etc. Use a touch screen stylus pen to keep your screen free from scratching and fingerprint.

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Lymphedema Garments and Compression Devices Used to Ease Lymphedema Pain

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