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Congress: House bill seeks to shield user fees from sequester with FDA S.O.S bill

July 18, 2013 4:47 pm | by Mass Device | News | Comments

Lawmakers on Capitol Hill have floated a proposal to protect user fees paid by medical device and drug companies to the FDA from federal budget cuts forced by sequestration. In March, the federal watchdog agency lost $210 million, or about 5.1% of its $4.1 billion 2013 budget, as a result of sequestration, a bargain between the White House and Congress.

ValveXchange applies for EU approval of a 2-part transcatheter valve

July 18, 2013 12:29 pm | by Mass Device | News | Comments

ValveXchange has its sights set on winning regulatory approval in Europe for its Vitality device, a product the company touts as the 1st serviceable bioprosthetic heart valve. Clinical trial enrollment to support European CE Mark approval wrapped up last month, and ValveXchange submitted all of its paperwork to the regulatory body DERKA Certification this week, according to a press release.

Obama Talks Up Healthcare Law's Rebates

July 18, 2013 12:08 pm | by Darlene Superville, Associated Press | News | Comments

President Barack Obama says his healthcare law is working and cutting costs for consumers, despite what the law's Republican critics say. At the White House Thursday, Obama emphasized half a billion dollars in rebates going to nearly 9 million people under a provision of the law he says is holding insurance companies accountable.

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Resolving disputes concerning FDA and medical devices

July 17, 2013 9:34 am | by Mass Device | News | Comments

Disagreements are inevitable in science, medicine – and even life. As part of a regulatory agency committed to public health, the FDA's medical devices center occasionally confronts scientific and policy disagreements among our staff and with the various stakeholders we strive to serve.

Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation

July 16, 2013 2:34 pm | by Patrick Kenny, Director of Analytical Services, Microtest Laboratories | Microtest Laboratories, Inc. | Articles | Comments

Device manufacturers need to ensure their product will be sufficiently cleaned by healthcare professionals. This article will focus on the areas of the FDA’s guidance document that are causing difficulties in cleaning validations, and will demonstrate how pre-validation laboratory work can help save time and money.

Brain Wave Test Device for ADHD

July 16, 2013 9:51 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis.

FLASH: Medical device tax payments hit the $1B mark

July 15, 2013 4:29 pm | by Mass Device | News | Comments

The 2.3% medical device sales tax has cost the industry an estimated $1 billion so far, according to a report released by a coalition of medical device lobbying groups, which called the milestone "frightening."The tax costs medical device makers an average of $194 million per month, funds which should be going to research & development efforts and to salaries for new employees...

A Breakdown of the Top 10 Critical RoHS2 Requirements

July 15, 2013 3:42 pm | by Katina Kravik, CEO, Northwire-NWI Lab360 | Blogs | Comments

While legal enforcement dates for RoHS2 compliance is July 22, 2014, Northwire, a leading OEM, is alerting their valued customers in medical equipment manufacturing of the critical details to make certain they comply with CE-mark. Originally published in July 2011, the Recast RoHS Directive dictates that all medical devices, electrical and electronic OEMs comply with new standards.

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Affordable Care Act Could Cause People to Leave Their Jobs

July 15, 2013 9:59 am | by Columbia University's Mailman School of Public Health | News | Comments

As a consequence of the Affordable Care Act, between 500,000 and 900,000 Americans may choose to stop working. That possibility is predicted in a new analysis of an analogous situation in reverse: the abrupt end of Tennessee's Medicaid expansion in 2005.

Medtronic's insulin pump recall gets FDA's highest-risk label

July 15, 2013 9:59 am | by Mass Device | News | Comments

The FDA put its highest-risk label, Class I, on a recall of Medtronic's (NYSE:MDT) Paradigm insulin infusion pumps, which the medtech giant had warned about earlier this year. Medtronic Canada said last month that it received 2 reports on its Paradigm and Polyfin infusion devices, concerning the over- and under-delivery of insulin therapy.

VeriTeQ’s Patented and FDA Cleared Technology Can Help Medical Device Manufacturers Comply with FDA Proposed Rule for Unique Device Identification – Direct Mark Requirement

July 15, 2013 8:00 am | by Business Wire | News | Comments

Digital Angel Corporation has announced that the patented VeriTeQ “Q Inside” radio frequency identification (“RFID”) microchip, cleared by the U.S. Food and Drug Administration (“FDA”), can help implantable medical device manufacturers comply with the FDA’s Proposed Rule for Unique Device Identification (“UDI”) – Direct Mark requirement.

Medicare Bidding Program Puts Diabetic Patients in Danger

July 11, 2013 2:25 pm | by PR Newswire | News | Comments

The American Association for Homecare warned today that the controversial Medicare bidding program for diabetic testing supplies is endangering beneficiaries by requiring the use of generic testing strips and monitors that are under scrutiny by physicians and the Food and Drug Administration for inaccurate readings.

Care Interrupted—Top Five Vulnerabilities in Medical Devices

July 10, 2013 3:17 pm | by Matt Neely, Director of Strategic Initiatives, SecureState | Blogs | Comments

Putting medical devices on the network provides a large number of benefits, such as supporting telemedicine and the easy transfer of test results to electronic medical records (EMR) systems. However, putting these devices on a network also introduces a number of risks.

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Medical device tax: "Citizen Cosponsors" take to web to support repeal

July 10, 2013 7:59 am | by Mass Device | News | Comments

Since its launch last month, House Majority Leader Eric Cantor's (R-Va.) Citizen Cosponsor website has listed nearly 3,000 bills, among them "Protect Medical Innovation Act of 2013," a measure to repeal the 2.3% medical device tax that took effect at the start of this year.

Halt Medical Announces New CPT® Code From the American Medical Association for RF Ablation of Uterine Fibroids

July 10, 2013 3:00 am | by PR Newswire | News | Comments

Halt Medical is very pleased to announce that the American Medical Association (AMA) Current Procedure Terminology (CPT) Panel has established a new CPT® code specifically for Radiofrequency (RF) Ablation of Uterine Fibroids. CPT codes are used by medical practitioners; including physicians, hospitals, and other healthcare providers to report healthcare services to insurers for the purpose of reimbursement.

Retina Implant AG's Alpha IMS Wins CE Mark

July 9, 2013 11:55 am | by Retina Implant AG | News | Comments

Retina Implant AG has announced that its wireless subretinal implant technology, the Alpha IMS, has received CE Mark. Retina Implant's technology, which has been in clinical trials across the world since 2005, is designed to restore useful vision in patients blinded by the degenerative eye condition retinitis pigmentosa.

Medical device tax: Congressional duo launches tax reform tour

July 8, 2013 2:48 pm | by Mass Device | News | Comments

Medical device industry lobbying groups rallied behind Sen. Max Baucus (D-Mont.) and Rep. Dave Camp (R-Mich.) as the Congressional duo embarked on a nation-wide tax reform tour, a possible boon to efforts to repeal the medical device tax.  

AdvaMed Supports Comprehensive Tax Reform Repeal of the Medical Device Tax

July 8, 2013 12:06 pm | by PR Newswire | News | Comments

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), released the following statement in response to tax-writing committee Chairmen Camp and Baucus as they begin their nationwide listening tour in favor of a simpler, fairer U.S. tax code.

FDA Clearance for Philips' AlluraClarity X-Ray System

July 8, 2013 11:08 am | by PRNewswire | News | Comments

In close collaboration with leading clinicians in the field of minimally-invasive medicine, Philips has been driving innovation in interventional imaging for more than 50 years, helping to guide procedures such as the catheter-based treatment of obstructed coronary arteries, brain aneurysms, heart rhythm disorders and defective heart valves.

FDA wants to downgrade blood access devices

July 8, 2013 10:57 am | by Mass Device | News | Comments

The FDA recommended bumping blood access devices down from Class III to Class II regulatory status, based on mounting evidence that these implanted tubes, catheters and cannulae belong in a lower-risk category. The federal watchdog agency said there's enough safety and efficacy data to peel off a layer of regulatory oversight.

FDA plows forward with researcher misconduct privacy rule

July 8, 2013 9:29 am | by Mass Device | News | Comments

The FDA this month issued a rule that would keep confidential certain records pertaining to investigations into potential researcher misconduct at the National Institutes of Health, exempting such documents from federal Privacy Act requirements.

Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers

July 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This draft guidance document describes and explains the Food and Drug Administration’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for certain device-related adverse events.

CorMedix Receives CE Mark for Neutrolin Catheter Lock Solution

July 5, 2013 11:05 am | by Business Wire | News | Comments

CorMedix has announced that it has received CE Mark approval for Neutrolin, a catheter lock solution, for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease. The Neutrolin solution includes an anti-coagulant and broad-spectrum antimicrobial combination that is active against common microbes.

Working together for new solutions to cancer in children

July 3, 2013 8:29 am | by Mass Device | News | Comments

One of the greatest pleasures I have as FDA commissioner is the opportunity to meet with so many who are making a real difference in the world of health care, including researchers, doctors, drug industry leaders, foundations, and advocates for patients and families, including most recently the Alexandria Summit for Oncology. 

E.U. scrutinizes medtech review "shopping"

July 3, 2013 7:29 am | by Mass Device | News | Comments

Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices. Specifically, the European Commission's proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.

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