510(k) Process Changes Will Be Available for Review Soon

FDA to Release 510(k) Report (HealthPointCapital) FDA’s Jeff Shuren talks about the upcoming changes to the 510(k) process

New Hours for Residents Proposed by the Accreditation Council for Graduate Medical Education (ACGME)

New standards for resident duty hours to be enacted in July 2011

FDA Accepts BioMimetics PMA Application for Its Human Platelet-Derived Growth Factor (RhPDGF-BB) for Use in Foot and Ankle Fusions

BioMimetic Therapeutics Receives Filing Letter from FDA for Augment™ Bone Graft PMA (Press Release)

Zimmer, Biomet and Others Are Fighting the New Industry Tax

Indiana medical device makers say fight isn’t over (IndyStar)

MIS Joint Surgery Is Easier With Mizuho’S New Operating Tables

Video: New hip replacement procedure means less downtime (AZ Family) Arizona Doctors Leading the Way With New Hip Replacement Technique (BusinessPortal24) http://www.mizuhosi.com/

Medtronic-Kyphon Launches Its New Bone Cement Containing HA – ActivOs 10

Kyphon’s New Cement (OrthopedicsThisWeek)

$1M Ohio Grants Are Awarded to Lanx, SpineForm and OrthoHelix Surgical Designs

Lanx Inc (Broomfield, CO) was awarded $1 million to form an Ohio division in Columbus to finalize the design and commercialization of a device to measure range of lumbar motion in patients with back injuries OrthoHelix Surgical Designs Inc (Medina, OH) was awarded $1 million to finalize the design of a variable-angle locking technology that [...]

BioSyntech Closes Asset Sale to Indian Investor, Piramal Healthcare Ltd(PIRA.BO), for $3.9M

Piramal Health to buy Biosy ntech for C$3.9 mln (Reuters India)

FDA’S Jeff Shuren Talks About the Upcoming Changes to the 510(k) Process

CDRH’s Shuren: FDA’s 510(k) findings due soon (MassDevice)

Baxano Closes $30M in Series C Funding to Support Commercialization of the iO-Flex System for Lumbar Stenosis Decompressions

Baxano, Inc. Announces Close of $30 Million Series C Funding (Baxano Press Release)

RTI Reorganizes Its Management Team

RTI Biologics Announces New Organization Structure (BusinessWire)

Fasten Your Seat Belts for the FDA’S “Comparative Effectiveness”

Comparative Effectiveness Expected to Have Significant Impact on Orthopaedic Industry (John Engelhardt quote) Comparative Effectiveness Hits Medical Devices (Medical Devices Today)

Medafor’s Shareholders Reject CryoLife’s Takeover Attempt

Medafor Shareholders Crush CryoLife (Orthopedics This Week)

Germany Surgeons Are Implanting Custom-Fit Resorbable Cranial Implants Made From Porous TCP/PLA

Laser Melting Bone Replacement (Medical News Today)

Zimmer’S Lawsuits With the Durom Hip Are Stacking Up – So Far, 45 Separate Lawsuits

Durom Hip Cases Consolidated (Orthopedics This Week) A familiar story for hip replacement doctor – Dr. Larry Dorr feels obligated to raise concerns about Zimmer’s Durom cup (OrthoStreams)

The OrthoVation Center, a Fort Wayne Orthopedic Incubator, Is Opened With Four Startups

First four startups are: Del Palma Orthopedics, Nanovis, BioSpine, and Sites Medical. Whitley County Company Introduces New OrthoVation Center (MSNBC) Whitley incubator started (Journal Gazette – Fort Wayne)

Connecticut Researchers Are Turning Embryonic Stem Cells Into Chondrocytes

Connecticut Researchers Turn Stem Cells into Chondrocytes (HealthPointCapital)

The Medical Device Industry Contributed 436K Jobs to Economy

Report: Med device industry contributes 436K jobs to economy (Fierce Medical Devices) … check out the full report here (.pdf) The medical device industry was responsible for 423,000 jobs, $24.6 billion in payroll and almost $136 billion worth of products in 2008. That represents an increase of 12.5 percent, 11.4 percent and 11.6 percent, respectively, over data [...]

Medtronic Uses Royalties to Compensate Surgeon Inventors – Dr. Larry Lenke’S Small Royalty Adds Up to Over $1M/year

Medtronic backs top doc with royalties (St Louis Business Journal)

Austin Has Become a Hotbed for Spine Startups – 14 Total (Tiger Buford Is Quoted in the Article)

Austin filled with ‘spine’ startups (Austin Business Journal)

MAKO Is Taking Its Robot to Scotland for a Randomized Clinical Knee Trial

MAKO Surgical Corp. to conduct clinical study in Scotland (OrthoSuperSite)

How Should Investors Navigate Orthopedics, the Largest Sector in the Medical Device Industry?

The orthopedics sector is now a $43 billion worldwide market, and is considered the single largest segment of the medical device industry. The State of Investments in Orthopedics (MDDI)

OrthoCyte Is Spun Out to Develop Novel Stem Cell Technology for Musculoskeletal Disorders

Arnold Caplan, PhD from Case Western will serve as CSO. He was the founder of Osiris Therapeutics. BioTime Forms New Subsidiary, OrthoCyte Corporation, to Develop Treatments for Orthopedic Conditions Using Stem Cell Technology (BusinessWire)

Wright Medical’S Ethics Are Questioned After a Major League Umpire Patient Experiences a Failed Ceramic Hip (Caution: Very One-Sided Bloomberg Article)

New Hips Gone Awry Expose U.S. Kickbacks in Doctors’ Conflicts (Bloomberg Business)

Wright Medical Enters the Skin Grafting Wound Market With a New Micro-Morselizing System

Wright Medical launches new skin grafting system (Memphis Business Journal) Wright Medical Group, Inc. Announces Global Commercial Launch of the XPANSION® Micrografting System for Less Traumatic Split-Thickness Skin Grafting (Daily Finance)

Curexo’S ROBODOC Used in Total Hip Surgery for the First Time

Curexo’s Next-Generation ROBODOC(R) Assists in First Surgery (PRNewsWire)

New Zealand Researchers Closer to Making Implants From Seashells That Will Ultimately Be Replaced by Bone

Research another step towards orthopaedic implants made from shell (Victoria News Article)

Tornier to Test the IPO Markets With a Planned Raise of $205M

Tornier is the #1 foot & ankle company in the US and the #2 shoulder company worldwide. Orthopedic device firm planning IPO (StarTribune Minneapolis) UPDATE 1-Tornier B.V. files for upto $205 mln IPO (Reuters)

Mountain Biking Spinal Injuries Are Studied for the First Time

Riding Into Spinal Injuries (Orthopedics This Week) 40% of mountain biking accidents involve spinal cord injuries 80% are cervical injuries Mean age 33, mostly men

BioSyntech Is Toast! Assets Sold to Piramal Healthcare Limited for $3.7M

Superior Court authorizes the sale of BioSyntech’s Assets (NewsWire) http://piramalhealthcare.com/ http://www.biosyntech.com/en/

Minimus Spine, Developer of Ozone Injection Technology, Lands $1M From Angel Investors

Austin-Based Minimus Spine Locks up Nearly $1M from Angel Investor (CityBizList)

Ascension Orthopedics Is Betting on Its PyroCarbon Shoulder… but It Is a Long Journey

Ascension is ready to bring PyroCarbon to shoulder replacement, but first it will have to contend with the FDA, payors, and at least one high-profile potential competitor. Ascension Orthopedics’ Fate May Rest on the Shoulder (Medical Devices Today)

Smith & Nephew Opens a Plant in Beijing to Make Hip and Knee Instruments

S&N Opens Beijing Plant (OrthopedicsThisWeek)

Some Surgeons Reconsider Use of Metal-on-Metal Hip Implants

Some Surgeons Reconsider Use of Metal-on-Metal Hip Implants (NewsInferno)

Anulex Technologies Lands 5th Round of Private Equity Financing Totaling $20M

Funds will support commercialization for the Xclose Tissue Repair System, and feasibility work on Rimclose. Anulex Technologies, Inc. to Raise a Minimum of $20 Million in Series E Financing (BusinessWire)

Complex Spine Procedures Are on Rise in Older Patients

Complex Spine Procedures on Rise in Older Patients (MedPageToday) “I think overall there probably is too much fusion happening at this point,” said Fischgrund, editor-in-chief of the Journal of the American Academy of Orthopaedic Surgeons. “But it’s probably all in an effort to do what people think is the best for the patient.”

Total Ankles Replacements Now Trump Ankle Fusions for Treatment of Late-Stage OA

New opinion from American College of Foot and Ankle Surgeons (ACFAS) Effective Alternative Treatments Available for Chronic Ankle Disability (PRNewsWire)

RoboDoc 2 Used in First Total Hip Case in the US

Sutter First in Nation to Use Next-Generation ROBODOC® for Hip Replacement (PRNewsWire)

Guaranteed!… “No Knee Replacement for 4 years” With BioniCare Device

VQ OrthoCare Unveils “The Better Knee Guarantee” on the BioniCare Treatment System (Pitch Engine) VQ OrthoCare’s BioniCare System is the first non-invasive, non-pharmaceutical, non-surgical treatment option for osteoarthritis of the knee. It delivers a low-level pulsed electrical signal to the knee through two electrodes held in place on the inside of a joint unloading brace, [...]

February 22, 2012

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