Category: Regulatory/ComplianceSyndicate content

Larger U.S. patients means larger medical devices | MassDevice.com On Call

April 4, 2013 by Arezu Sarvestani

Growing obesity in the U.S. means that medical device manufacturers, along with many other industries, must revise their products to accommodate a "larger" market.

MassDevice On Call

MASSDEVICE ON CALL — Makers of durable medical equipment have had to shift their manufacturing parameters in recent years in order to accommodate the ever-growing rates of obesity in the U.S.

It's sometimes a "heartbreaking" situation for patients, but it's also a potentially lucrative opportunity for device makers and clinicians. Clinics generally pay a premium for bigger devices, but the technology has become a medical necessity.

Diabetes: J&J recalls OneTouch Verio IQ glucose meters over failure to warn at extreme levels

April 3, 2013 by Arezu Sarvestani

Johnson & Johnson's OneTouch Verio IQ blood glucose meters were found to shut off at extremely high glucose levels, prompting a recall of all lots of the device.

Johnson & Johnson, LifeScan OneTouch Verio IQ blood glucose meters

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FDA's new global cardiovascular registry to start with transcatheter heart valves

April 3, 2013 by Arezu Sarvestani

The FDA announces a public meeting to discuss international cooperation in monitoring and assessing cardiovascular medical devices, with an initial pilot phase to focus on transcatheter heart valves.

FDA logo

The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.

The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."

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FDA OKs Hitachi Medical CT scanner

April 3, 2013 by Brad Perriello

Hitachi Medical wins 510(k) clearance from the FDA for its scalable Scenaria Advanced 128 CT scanner

Hitachi Medical

Hitachi (NYSE:HIT) said it won 510(k) clearance from the FDA for its Scenaria Advanced 128 CT scanner, the latest in its line of scalable CT scanners.

Hitachi Medical Systems America said the latest iteration of the Scenaria Advanced includes new low-dose technology designed to reduce patients' exposure to X-ray radiation.

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The March HIT standards committee meeting

April 3, 2013 by MassDevice

Dr. John Halamka, Chief Information Officer for Beth Israel Deaconess Medical Center, records his experiences with infrastructure, applications, policies, management and governance.

Dr. John Halamka

The March HIT Standards Committee focused on streamlining test scripts for certification, an overview of FDA Universal Device Identifier rule making, clinical summary formats for Long Term Care, and the latest updates from ONC.

We began the meeting by reflecting on the recent HIMSS conference, noting that the culture and momentum for EHR and HIE adoption in the US have changed to the point that there is no longer of question achieving our meaningful use attestation goals. 

FDA clears Medtronic's Affinity Fusion blood oxygenation system

April 2, 2013 by Brad Perriello

The FDA grants 510(k) clearance to Medtronic's Affinity Fusion blood oxygenation systems, designed to replicate the lungs' function during open heart surgeries.

Medtronic

Medtronic (NYSE:MDT) said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs.

The Minneapolis-area medical device company, which is the world's largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient's blood to remove particles and air during oxygenation.

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FDA issues new guidance on medical device user fee refunds and exceptions

April 2, 2013 by Arezu Sarvestani

The FDA outlines cases in which a manufacturer can expect a refund of the user fees paid for the FDA's review of a medical device.

FDA logo

The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.

The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

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