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Knees

Orthopedic survey: U.S. knee/hip market has hit bottom

April 13, 2012 by MassDevice staff

A survey of orthopedic docs by investment bank Leerink Swann yields mixed messages for the U.S. market for hip and knee reconstructions.

The U.S. market for hip and knee reconstructions may have hit bottom, but there's still a long way to go, according to a survey of orthopedic surgeons.

The investment bank Leerink Swann polled 76 "high volume" orthopedic surgeons, concluding that the knee and hip reconstruction market is "stable" but not "improving," with most knee and hip docs reporting unchanged patient surgery wait times and "only modest expectations in their next 12 month procedure growth forecasts."

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ConforMIS calls out Stanmore Implants on custom knee patents

March 21, 2012 by MassDevice staff

ConforMIS contests Stanmore Implants' claims to a custom knee implant replacement system patent with the U.S. Patent & Trademark Office.

ConfoMIS logo

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.

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St. Jude's Riata recall evidence of nationwide issue, doc says | MassDevice.com On Call

March 6, 2012 by MassDevice staff

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

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.

MassDevice.com Podcast: ConforMis CEO Philipp Lang

February 15, 2012 by MassDevice staff

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.

MassDevice.com Q&A: CoforMIS CEO Philipp Lang

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.

White House budget to cut health funding by $360 billion | MassDevice.com On Call

February 13, 2012 by MassDevice staff

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

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.

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Conformis nets $89 million in Series E round

January 30, 2012 by MassDevice staff

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 logo

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.

FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs

January 19, 2012 by MassDevice staff

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.

Knee

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.

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