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FDA News Device Daily Bulletin
- Lack of Foreign MDRs Results in Warning to ELA Medical
French devicemaker ELA Medical has been warned for not reporting adverse events that occurred outside the U.S. involving the same devices it distributes in the U.S.
- Parts of FDA 2011 Budget Proposal Are Worrisome to Device Industry
The FDA’s proposed 2011 budget includes new user fees for devicemakers.
- Becton Dickinson Recalls Luer Devices, Catheter Systems
Becton Dickinson is voluntarily recalling lots of BD Q-Syte luer access devices and BD Nexiva Closed IV catheter systems, the company says.
- AdvanSource Polymer Products Comply With European Council Guidelines
AdvanSource Biomaterials Corporation, a leading developer of advanced polymer materials for a broad range of medical devices, Monday announced that its polymer product lines are compliant with measures applying to the processing of certain animal waste to protect against transmissible spongiform encephalopathies as set forth in European Council Decision 1999/534/EC.
- FDA Urges Caution on Powerheart, CardioVive Automated External Defibrillators
The Food and Drug Administration (FDA) is alerting users of certain Powerheart and CardioVive automated external defibrillators that these devices may malfunction unexpectedly.
- CryoLife Urges Medafor to Enter Acquisition Discussions in Timely Manner
In a letter to Medafor’s Board of Directors, CryoLife Inc. urged Medafor to enter into discussions with CryoLife in a timely manner as delaying negotiations with CryoLife simply delays the creation of value for Medafor’s shareholders.
- Abbott Submits New Automated Ovarian Cancer Test for US Approval
A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.
- Synovis Life Technologies Receives FDA Marketing Clearance for Flow Coupler
Synovis Life Technologies, Inc., has received Food and Drug Administration 510(k) marketing clearance for its Flow Coupler, an innovative extension of the company’s well-established Microvascular Anastomotic Coupler used in several surgical procedures to connect small blood vessels more quickly and with equal or greater reliability than hand suturing.
- Medical Device Startup Osseon Gets Traction
Medical device startup Osseon Therapeutics has reached break-even in three short years, and its bone cement delivery system is in high demand among physicians and surgery centers, said a company spokesman.
- Medical Acoustics Exhales With Product on Market
Medical Acoustics LLC was thrilled to get a call last fall from Popular Science magazine, which wanted to feature its therapeutic lung flute product among the 100 Top Innovations for 2009 in the December issue.
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