Stryker Corp. (NYSE:SYK) is fielding legal challenges on two fronts, one from a former distributor and DePuy Spine and another from a Utah man claiming a Stryker pain pump destroyed his shoulder.
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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.
DePuy Orthopaedics names Andrew Ekdahl president
DePuy Orthopaedics has a new man in the corner office, now that it’s named veteran Andrew Ekdahl president of the Johnson & Johnson (NYSE:JNJ) subsidiary.
Ekdahl will replace David Floyd, who resigned in March amid a damaging recall of one of DePuy’s hip replacement lines that’s already cost the company nearly $1 billion in legal expenses. The 20-year veteran of the company’s orthopaedics, trauma, sports medicine, neurosciences and spine units was the franchise vice president for DePuy Europe, Middle East and Africa.
Bone partnership signed by Lilly and Synthes
Swish medical device maker Synthes Inc. and pharmaceutical goliath Eli Lilly & Co. (NYSE:LLY) have partnered to develop a new suite of orthopedic products and osteoporosis treatments.
The companies signed an exclusive worldwide collaboration agreement for development and licensing of early-development products combining Lilly biologics and Synthes biomaterials.
Feds seek prison time for Synthes execs
Federal prosecutors want four former Synthes Inc. executives to spend up to a year in jail after they pleaded guilty to their roles in an un-authorized bone cement trial in which three patients died during surgery.
Indiana Gov. Mitch Daniels signs on for medical device conference
Indiana Gov. Mitchell Daniels won’t be running for the GOP nomination in 2012, but his name still draws water for medical device makers, who picked him to address the annual conference of the country’s largest medical device industry council.
The Advanced Medical Technology Assn. said today that the governor of the Hoosier State will be a featured speaker at AdvaMed 2011, the council’s annual fall gathering.
Neoprobe sells radiation detection sector to Devicor | Acquisitions roundup
Cancer diagnostics firm Neoprobe Corp. (NYSE:NEOP) sold its Gamma Detection Systems sector to Devicor Medical Products Inc. in a deal that’s worth up to $50 million.
Devicor, based in Pleasant Valley, Wis., agreed to pay $30 million up front and up to $20 million in royalty payments.
Dublin, Ohio-based Neoprobe will get the full royalty payment if Devicor tops $21 million in sales of the devices in the next five years.
DePuy Pinnacle hip implant lawsuits consolidated in Texas | Legal Roundup
A group of at least 57 product liability lawsuits filed against Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics over one of its metal-on-metal hip implants were consolidated in the U.S. District Court for Northern Texas.
FDA probes for data on metal-on-metal hip implants
The FDA asked Johnson & Johnson (NYSE:JNJ) and a score of other medical device makers for data on metal levels in the blood of patients implanted with metal-on-metal hip implants.
Abbott’s FreeStyle glucose meter wins CE Mark
Abbott (NYSE:ABT) won CE Mark approval for its FreeStyle InsuLinx blood glucose monitor, its first to include a mealtime (bolus) insulin calculator.
The Abbott Park, Ill.-based health care leviathan said it plans to have the system on the 55.4-million-patient market in Europe this month, beginning with Belgium, France, Germany, Netherlands, and the United Kingdom.
Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:
Smith & Nephew not jealous over Synthes/JNJ union
Officials at Smith & Nephew (NYSE:SNN) weren’t acting brides left at the altar, but they weren’t exactly tossing bouquets to the hot new couple in the orthopedic market during a conference call with investors today.