Medical Devices Today

Medical Device Market 2009: Interventional Cardiology

Elsevier Business Intelligence announces the publication of a new Special Report: Medical Device Market 2009 Interventional Cardiology. Who’s going beyond catheters and drug-eluting stents in this vibrant space. A special report previously published in IN VIVO: The Business & Medicine Report™  Read more...

New Developments in Obesity Intervention

Article preview reprinted from Medtech Insight -September/October 2009

With soaring medical costs weighing heavily on the US economy, it's not surprising that obesity has become a target in the health care reform debate. Obesity is costly because it significantly increases the risk of many chronic diseases. Exercise, dieting and prescription drugs have had a limited effect in stemming the tide of obesity, leaving bariatric surgery and other interventional techniques as the primary treatment options for this potentially multi-billion dollar market. But device manufacturers have a challenge ahead of them--to develop more effective, safer, and less invasive obesity therapies that will not only result in long-term weight loss, but will also cut treatment costs and better manage comorbidities. Read more...

Invatec: Translating Global Success in Vascular Devices to the US Market

Article preview reprinted from IN VIVO -  September/October, 2009 

Invatec has grown to be the leading native European interventional vascular device company and has now set its sights on the US market. By focusing first on peripherals and following with drug-eluting balloons, not stents, Invatec is looking to compete against the major device companies on their home turf. Read more...

Pfizer, J&J; See Promise, Make Investment in Cancer Device Company

Full article reprinted from Start Up - September/October 2009

Pfizer's venture group invested alongside Johnson & Johnson Development Corp. and Index Ventures in NovoCure Ltd., a device company developing a treatment to bolster the affect of chemotherapies. Read more...

MedCAC Calls For More Research On Catheter Ablation For Atrial Fibrillation

Article preview reprinted from "The Gray Sheet" - October 26, 2009

More evidence is needed to determine the benefits of using catheter ablation for treating atrial fibrillation, especially in the frail elderly population, according to the Medicare Evidence Development and Coverage Advisory Committee. Read more...

FDA Completes UDI Pilot, But Anxieties Over Data Requirements Remain

Full article reprinted from "The Gray Sheet" - October 26, 2009

Participants in a six-week pilot program for a unique device identification database expressed some anxiety about the volume and type of information required for the program, according to MJ Wylie, director of global data standards at GHX. Read more...

Lurie Joins FDA: Critic Of Agency, Industry Will Help Make Regulatory Policy

Full article reprinted from "The Gray Sheet" - October 26, 2009

One of the most outspoken critics of the device industry and FDA's device center has been named to a top-level position within the agency. Read more...

Introducing: The FDA Advisory Committee Survival Manual

Introducing: The FDA Advisory Committee Survival Manual
A Step-by-Step Guide to Preparing for a Successful Hearing

 

The FDA Advisory Committee Manual is a 159-page book written by 3D Communications to help prepare and guide companies through the FDA advisory committee approval process. Click here to order your copy today.

siRNA Opening Up CNS Device Opportunities

Full article reprinted from Start Up - September/October 2009

Start-Up -- The neurodegenerative disease R&D collaboration between RNA interference specialist Alnylam and device maker Medtronic--the first siRNA-oriented convergence opportunity--appears to be inching closer to the clinic. Key to the program's success to date are refinements in the Medtronic catheter and infusion -pump system used to deliver the Alnylam compund, in keeping with Medtronic's strategic goal of better understanding the mechanics of delivering chronic drugs into the brain. Read more...

Rockwell Medical Technologies nets $20.7mm via RDO

Deal summary reprinted from Strategic Transactions - September 2009

Rockwell Medical Technologies (hemodialysis solutions and kits) has netted $20.7mm through the registered direct offering of 2.84mm common shares at $7.75 (a 9% discount) to a group of institutional investors led by Deerfield Management. Read more...