ConforMIS contests Stanmore Implants' claims to a custom knee implant replacement system patent with the U.S. Patent & Trademark Office.
Burlington, Mass.-based ConforMIS filed documents officially contesting a patent application for a personalized knee replacement system that Stanmore Implants claims to be the world's 1st.
The problems with St. Jude Medical's Riata lead, which the company eventually recalled, could have been caught earlier if not for lax policies and practices at the FDA, according to Minneapolis Heart Institute's Dr. Robert Hauser.
MASSDEVICE ON CALL — The problems with St. Jude Medical's (NYSE:STJ) recalled Riata defibrillator leads should have been caught sooner, according to a prominent heart doctor.
Dr. Robert Hauser, of the Minneapolis Heart Institute, in an article for the New England Journal of Medicine, wrote that problems with the leads, which remain active in an estimated 79,000 U.S. patients, went uncovered for too long because of lax post-market surveillance.
ConforMIS CEO Philipp Lang talks to MassDevice.com on how the custom orthopedic implant maker plans to spend its most recent $90 million funding round and on what makes his company stand out in the crowded orthopedics arena.
Philipp Lang has ConforMIS looking to get a leg up on the knee replacement industry.
Last week, the Burlington, Mass.-based orthopedic implant maker said it raised $89 million in a Series E round from several investors, bringing the total nut raised by ConforMIS over the last 3 years to more than $140 million – a somewhat remarkable amount, given the fundraising climate over the past few years.
President Barack Obama's budget plan is expected to cut $360 billion in health care funding, including $300 billion from Medicare, over the next 10 years.
MASSDEVICE ON CALL — The White House's budget proposal is expected to cut $360 billion in health care spending over the next 10 years, according to a budget summary released last week.
That bulk of the cuts, $300 billion, will come from Medicare programs.
The proposal has changed little since President Barack Obama released the initial $3 trillion savings plan in September, Healthwatch reported.
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.