The Burlington, Mass.-based orthopedic device maker nets $89 million in a Series E round CEO Philipp Lang says it will use to build out a direct sales force for its personalized knee implant.
ConforMIS Inc. said it's closed another massive funding round to support its line of personalized knee implants.
The Burlington, Mass.-based orthopedic device maker said it raised $89 million in a Series E round from several investors, including AGC Equity Partners and Axel Johnson, along with government investment funds from Asia and the UAE.
ConforMIS has now raised about $140 million since 2009.
The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage.
The FDA this week issued new guidance on getting clearance for clinical trials of products intended to repair or replace knee cartilage.
The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.
The new guidance is the finalized form of a draft in the works since July 2007, and includes sections detailing clinical study schedules and non-clinical data considerations in response to comments the agency received during the draft process.
Washington Gov. Christine Gregoire is joined by 11 state attorneys general in defending the individual insurance mandate in the President Barack Obama's health care overhaul.
MASSDEVICE ON CALL — Washington state governor Christine Gregoire joined 11 state attorney generals in voicing defense for the individual insurance mandate in President Barack Obama's health care overhaul.
The group filed documents in support of the mandate with the U.S. Supreme Court, where challenges to the health law are expected to undergo initial arguments in March.
Each filed a separate amicus brief, Law360.com reported, including Gregoire and Massachusetts Attorney General Martha Coakley.
X-ray of the knee of an OCD
patient, with arrows pointing
to tell-tale irregularities in
the surface of the joint.
(Uniformed Services University/
By Benton Heyworth
Artificial hip and knee makers cut payments made to orthopedic surgeons after a 2007 DOJ probe cost them $311 million.
MASSDEVICE ON CALL — The top artificial hip and knee makers cut spending on consultants after a federal case charged them with providing illegal kickbacks.
Analysts at Leerink Swann lower their sales and earnings estimates for Stryker Corp. and Zimmer Holdingson its soft forecast for the hip and knee implant markets.
Expectations of softer markets for hip and knee implants prompted analysts at Leerink Swann to lower their sales and earnings expectations for Stryker Corp. (NYSE:SYK) and Zimmer Holdings (NYSE:ZMH).
The researchers said they adjusted their takes on companies' the top and bottom lines "primarily to reflect more conservative hip/knee growth assumptions."
The top three medical device stories for August 24, 2011.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com's coverage highlights our three biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
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