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Devicesdiagnosticsletter

View Archived Issues

April 21, 2014

Vol. 41
No. 16

Headlines

Guidance: Sponsors Must Consider Risks With Live Case Presentations

The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More

FDA Guidance Sets Limits on Endotoxins in Eye Devices

The FDA is setting new endotoxin limits for several types of single-use intraocular ophthalmic devices. Read More

Varian to Pay U of Pittsburgh $35M to Settle Patent Suit

Varian Medical Systems will pay the University of Pittsburgh $35 million to settle claims that its Real-Time Position Management device infringed on a patent held by the university. Read More

Endo Health’s Transvaginal Mesh Unit Lands FDA Warning Letter on CAPA

A Minnesota-based unit of Endo Health Solutions has landed an FDA warning letter, the Irish devicemaker says in a Wednesday SEC filing. Read More

Injunction Would Force Medtronic to Take CoreValve off U.S. Market

Heart patients in the U.S. would no longer have access to Medtronic’s CoreValve transcatheter valve if a preliminary injunction handed down in federal court takes effect. Read More

FDA Warns on Fibroid Treatment, Plans Meeting to Discuss Risks

Laparoscopic devices commonly used to treat uterine fibroids could spread cancerous tissue, the FDA said Thursday in a safety communication discouraging the use of the procedure. Read More

Spine Surgery Gel Disagreement to Move to Dispute Resolution Panel

FzioMed will get to argue its case for Oxiplex spine surgery gel before the FDA’s Dispute Resolution Panel on June 10. Read More

Dx Maker Gets Warning On Shared Assembly Table, Acceptance Criteria

LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More

FDA Authorizes Emergency Use of Quidel Influenza Assay

The FDA has granted Quidel an emergency use authorization for its Lyra Influenza A Subtype H7N9 assay. Read More