Fenwal Inc. said it landed 510(k) clearance from the FDA for a new version of software for its Alyx blood collection system.
Fenwal lands 510(k) clearance for Alyx blood collection software
Fenwal Inc.
FDA lets Cooper’s Avaira Toric back on the market | Regulatory Roundup
Cooper Cos. (NYSE:COO) today announced that the U.S. Food and Drug Administration has granted a Special 510(k) clearance for CooperVision’s Avaira Toric two-week silicone hydrogel contact lenses for astigmatism.
CooperVision will re-launch Avaira Toric with shipments available for select distribution beginning in early May 2012.
Analyst: CRM market “bad as it’s ever been” | Wall Street Beat
The cardiac rhythm management market is "about as bad as it has ever been," according to an analyst with Gabelli & Co., due in part to headwinds from a federal probe and a negative journal article.
Fenwal wins patent suit over Haemonetics | Legal News
Fenwal Inc. won a nearly 6-year battle against Haemonetics Corp. (NYSE:HAE) over blood separation technology, after a federal judge in Massachusetts ruled in its favor this week.
The case dates back to 2005, when Haemonetics accused the then-Baxter Healthcare (NYSE:BAX) subsidiary of infringing a patent for a portable blood-collection device.
Court Rules in Favor of Fenwal in Nearly 6-Year U.S. Patent Dispute with Haemonetics
LAKE ZURICH, Ill.–(BUSINESS WIRE)–The United States District Court for the District of Massachusetts has
granted Fenwal’s motions for summary judgment in two related patent
lawsuits brought by Haemonetics Corporation in 2005 and 2009. In its
ruling, the court held that the Fenwal Alyx® system kits do
not infringe the Haemonetics patent.
“We respect the intellectual property of other companies and have said
from the beginning that these suits have no merit”
DePuy gets FDA clearance for new hip amid lawsuit over old hip | Regulatory Roundup
Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.
Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.
Caliper and HistoRx collaborate on biomarkers | Distribution roundup
Here’s a roundup of companies announcing new distribution deals.
UPDATE: USPTO upholds Haemonetics patent in spat with Fenwal
A federal court put the kaibosh on a lower court’s decision to award $15.7 million to Haemonetics Corp. (NYSE:HAE) in a patent spat with Fenwal Inc.
Haemonetics sued Fenwal in 2005, alleging that the then-Baxter Healthcare (NYSE:BAX) subsidiary infringed a Haemonetics patent for a portable blood-collection device.
