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Baxter recalls dialysis solution over contamination concerns

August 18, 2014 by Arezu Sarvestani

Baxter International recalls 2 lots of its peritoneal dialysis solution after finding potential contamination during the manufacturing process.

Baxter recalls dialysis solution over contamination concerns

Baxter (NYSE:BAX) is pulling back 2 lots of its peritoneal dialysis solution over concerns that the product may have been contaminated during the manufacturing process.

Enhancement Medical recalls all product over manufacturing concern

August 15, 2014 by Arezu Sarvestani

The FDA puts its highest-risk label on a recall of Enhancement Medical's Expression intranasal gel after the company gets nearly 70 complaints.

Enhancement Medical recalls every unit of its flagship product

Enhancement Medical got the FDA's highest-risk recall warning over manufacturing concerns about the company's Expression Intranasal Splint.

FDA issues new draft guidance on Class III de novos, UDI for small entities

August 14, 2014 by Arezu Sarvestani

The FDA proposes guidance for its de novo medical device review pathways and finalized its advice for small companies who must comply by the new Unique Device Identifier rules.

FDA issues new draft guidance on Class III de novos, UDI for small entities

The FDA issued a pair of new documents this week outlining the agency's thinking on review of breakthrough medical devices and providing guidance for small companies trying to keep up with the new Unique Device Identifier program.

In a draft guidance proposed today the FDA offered some advice for companies developing novel devices that they believe are low-risk and thus eligible for more lenient review.

XVIVO Perfusion wins FDA approval for donor lung transport system

August 13, 2014 by Arezu Sarvestani

Sweden-based XVIVO Perfusion lands FDA Humanitarian Use Device approval for its flagship XPS system for preserving donor lungs.

XVIVO Perfusion wins FDA approval for donor lung transport system

The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.

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