Medical Devices Today

Vermont Gift Ban and Spend Reporting Law Takes Effect

From our featured sponsor R-Squared - July 2009

On July 1 st , the strictest gift ban in the country took effect, banning most meals, fellowship support, and even donations to free clinics.  The law also expands the existing pharmaceutical marketing disclosure law, adding medical device and biologics manufacturers (and wholesale distributors of medical devices) to the types of companies required to track and report certain payments and expenditures to the state on an annual basis (i.e., “aggregate spend compliance”).  Compliance requirements are numerous and violations of the laws can carry significant financial penalties.    
  
R-Squared has published a comprehensive, 28-page, Manufacturers Compliance Quick Reference covering the new Vermont Gift Ban and Spending Reporting requirements. 

Click here to receive a complimentary copy.

Stryker to sell LiquiBand for Advanced Medical Solutions

Deal summary reprinted from Strategic Transactions - July 2009

Advanced Medical Solutions PLC (wound care) has granted Stryker exclusive worldwide marketing and distribution rights to certain craniomaxillofacial (CMF) products in its LiquiBand line of wound closing adhesives. Read more...

Eisai To Market U.K.'s Biocompatibles' Drug-Eluting Beads In Japan; Dips Toes In Device R&D Risk

 Full story reprinted from PharmAsia News - July 30, 2009

TOKYO - In a rare arrangement for a Japanese pharma, Eisai said July 28 it signed a licensing agreement with Biocompatibles International to develop and market the U.K. company's drug-eluting bead products DC Bead and Precision Bead in Japan. Read more...

MAKO Surgical: Navigating Robotics in Orthopedics

Article perview reprinted from IN VIVO - June 2009

All but dead a half a dozen years ago, MAKO Surgical is alive and well with an innovative technology platform that both embraces robotics and looks past it. Key to MAKO's strategy: a focus on unicompartmental knee procedures that are extremely difficult to do manually but, company officials hope, are significantly enabled by its robotic arm platform. If company officials are right, MAKO's robotics system could help explode the unicompartmental segment of the knee market without cannibalizing the total knee replacement segment. This year's AAOS meeting was a kind of coming out party for MAKO, whose major challenge now is convincing surgeons that robotics is more than just an intriguing gadget-it's a critical part of the surgical armamentarium. Read more...

Under New Leadership, FDA Diagnostics Office To Tighten Its Control

Full article reprinted from "The Gray Sheet" - July 27, 2009

Taking its cue from the new, more aggressive FDA administration, the agency's diagnostics office aims to tighten its regulatory control over commercial tests and, potentially, lab-developed assays, according to the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez. Read more...

FDA Panel Is Wary Of Cardiovascular Adhesion Barrier Trials

Full article reprinted from 'The Gray Sheet" - July 27, 2009

Panelists advising FDA officials on how to design clinical trials for cardiovascular adhesion barriers said that until they better understand the benefits of these devices, they are reluctant to expose heart patients to more than the slightest of risks. Read more...

Synthes Officials Plead Guilty To Charges They Bypassed FDA Approval

• Medtronic Gets Nod From FDA Advisers For New Type Of Heart Valve
• Covidien CEO Focused On Firm’s R&D, Laparoscopic Surgery Devices
• Smith & Nephew, Hologic Work On Less-Invasive Devices For Women
• Medtronic, J&J, Other Device Makers In Talks To Cut Health Care Costs
• Boston Scientific’s New CEO Sees No Change In Financial Goals
• Boston Sci Sees Expanded Heart-Device Implant Market From Study
• Synthes Officials Plead Guilty To Charges They Bypassed FDA Approval
• Medtronic, DePuy, Others Listed For Unreported Pay To Fired L.A. Surgeon
• Smith & Nephew Suits Challenge KCI Leadership In Device Sector
• Respironics, Masimo Settle Suits Over Monitoring Device Technology
• Medtronic CEO Got $8.9 Million In Compensation In Less Than Year On Job
• Roche, Bayer Could Face Higher Standards For Blood-Glucose Monitors
• Edwards Leads U.S. Device Maker For Reform Of Japanese Approval Pace
• St. Jude Wireless Pacemaker Devices Approved By FDA

Symetis Gets CHF23mm Through Its Series B Round

Deal summary reprinted from Strategic Transactions - July 2009

Symetis SA, which is developing the Acurate self-positioning device for percutaneous aortic valve replacement, has raised CHF23mm ($21.3mm) through its Series B venture round. Vinci Capital & Renaissance and Wellington Partners led the financing and were joined by fellow first-time investor Banexi Venture Partners and current shareholders Aravis Venture, BioMedInvest, Novartis Venture Funds, Truffle Capital, and individual backers. Symetis will use some of the funds to start in vivo preclinical testing of its Acurate TF transfemoral device.

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Direct from India: GMP Deviations Lead WHO To Issue "Notice Of Concern" To Matrix Labs

 

Click here to watch the video on CNBC

Editor's Note: For those of you who don’t regularly watch CNBC’s India affiliate, you may have missed PharmAsia News' own Vikas Dandekar on previous installments, but I thought I would forward the link to his interview this morning about the story he broke for PharmAsia News:

GMP Deviations Lead WHO To Issue "Notice Of Concern" To Matrix Labs; May Suspend Prequalified Anti-AIDS Products

Full story reprinted from PharmAsia News - July 24, 2009

MUMBAI - The Indian drug industry received another blow to its reputation when the World Health Organization issued a "Notice of Concern" to Hyderabad-based Matrix Labs, which is now 90 percent owned by Mylan, the third-largest generic drug maker in the world. Read the whole story...

SPOC Inc. (Stevens Proof of Concept)

Article preview reprinted from Start Up - June 2009

Low back pain affects 80% of Americans and is a leading cause of disability. Yet even though soft tissues including muscles are the primary source of this pain, many physicians neglect them and focus instead on spinal vertebrae, discs and nerves. And in cases where muscles are considered, pinpointing the exact muscle that causes the pain is extremely difficult with today's conventional diagnostic methods. The muscle pain detection device from SPOC Inc. (Stevens Proof of Concept) is noninvasive technology that uses electrical stimulation to diagnose muscle pain in any part of the body. The company believes its use will prevent many unnecessary spine surgeries that result in failed back surgery syndrome, which can occur in as many as 50% of cases. Read on...