Medical Device Industry News

Medical Device Developers – Network at MD&M East Next Week

Fri, 18 May 2012 21:08:00 +0000

PHILADELPHIA, Pennsylvania, May 18, 2012 /PRNewswire/ — This is your last week to pre-register for MD&M East, providing Medical Device Developers direct access to

FDA Warns Against Untested MS Treatment, Calls for Rigorous Studies

Fri, 18 May 2012 20:55:00 +0000

The FDA is advising physicians and clinical trial sites that may be studying an experimental procedure for multiple sclerosis (MS) that they need to get investigational device exemption (IDE) approval to proceed.

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FDA Warns Against Untested MS Treatment, Calls for Rigorous Studies

Device Tax Hearing Draws Comments on Retail Exemption, Enforcement

Fri, 18 May 2012 20:55:00 +0000

Devicemakers used a Wednesday Internal Revenue Service public hearing to continue their crusade against next year’s launch of the medical device excise tax, calling it burdensome and ill-conceived.

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Device Tax Hearing Draws Comments on Retail Exemption, Enforcement

CBO: MDUFA Would Save Fed Money, But Could Be Unfunded Mandate

Fri, 18 May 2012 20:55:00 +0000

The current round of FDA user fee reauthorizations stands to save the federal government $71 million by 2017, and $358 million by 2022, according to a recent congressional analysis.

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CBO: MDUFA Would Save Fed Money, But Could Be Unfunded Mandate

Senate Vote on Revised User Fee Package Planned for This Week

Fri, 18 May 2012 20:55:00 +0000

The Senate plans to debate and vote on an omnibus FDA user fee bill this week, after lawmakers substituted a new bill for the prior reauthorization package and began discussing it on Thursday.

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Senate Vote on Revised User Fee Package Planned for This Week

FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says

Fri, 18 May 2012 20:55:00 +0000

CDRH officials plan a series of public forums in 2012 to gather data to develop an implementation plan for the center’s Case for Quality Initiative – which aims to create an ongoing culture of quality at medical device manufacturers.

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FDA Increasing Role in Quality Promotion for Devicemakers, CDRH Official Says

ApniCure Receives FDA 510(k) Clearance to Market Winx(TM) Sleep Therapy System for Treatment of Obstructive Sleep Apnea

admin — Fri, 18 May 2012 13:11:25 +0000

Winx System Allows Users to Breathe Naturally Without a Mask Clinical Data From ATLAST Study to Be Presented at 2012 American Thoracic Society Conference REDWOOD CITY, CA–(Healthcare Sales & Marketing Network)- ApniCure, a medical device company foc… Devices, FDA Apnicure, obstructive sleep apnea, Winx, Sleep Therapy, sleep apnea

IMDS Announces Refinancing Transaction, Changes to Board of Directors

Fri, 18 May 2012 13:00:00 +0000

FORT WORTH, Texas–(BUSINESS WIRE)–IMDS® (Innovative Medical Device Solutions) announced the refinancing of its senior and subordinated debt obligations and changes to its Board of Directors. “The refinancing of our debt facilities is an important milestone in supporting IMDS growth objectives,” said Brady Shirley, the company CEO. “As a result of this transaction, IMDS gains access to substantial incremental capital and a reduction in the cost of our debt obligations – with the result of havin

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IMDS Announces Refinancing Transaction, Changes to Board of Directors

SurgiTech licenses Amendia SurgiFile spinal decompression system

Fri, 18 May 2012 12:24:07 +0000

SurgiTech, a developer of powered cutting instruments, has entered into an agreement to license Amendia’s SurgiFile spinal decompression system.

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SurgiTech licenses Amendia SurgiFile spinal decompression system

Numerex develops new wireless solution for MicroMed HeartAssist5 system

Fri, 18 May 2012 10:14:00 +0000

Numerex, a provider of machine-to-machine (M2M) products and services, has developed a new wireless monitoring device-network-application (DNA) solution for MicroMed’s HeartAssist5 left ventricular assist device (LVAD).

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Numerex develops new wireless solution for MicroMed HeartAssist5 system