Medical Devices Today

Boston Scientific’s New Small-Vessel Stent Gets FDA Approval

 
Medtronic, DePuy Named As Contributors To Non-Disclosing Professor

Covidien Gets Shareholder Permission To Move Tax Address To Ireland

Boston Scientific’s New Small-Vessel Stent Gets FDA Approval

Medtronic Gets FDA Limited Approval For Neck Disc

Ethicon Endo-Surgery Gets Mixed FDA Review For Sedation Device

Cardinal Health Executives Settle With SEC Over Securities Fraud Charges

Enzo Biochem acquires Assay Designs for $12.2mm cash

Deal summary reprinted from Strategic Transactions - March 2009

Enzo Biochem has acquired privately held Assay Designs (research products) for $12.2mm in cash. Assay will become part of Enzo's gene analysis division Enzo Life Sciences. Find out more...

Sorin Restructured: Interview with Andre-Michel Ballester

Article preview reprinted from IN VIVO -  April, 2009  

Sorin, as a whole, has historically been known as a company more focused on R&D and technology development than on the commercial side of the business. Despite being among the market leaders in several cardiovascular product segments in both Europe and Asia, outside of cardiopulmonary devices Sorin is not a significant player in any other US product area. Sorin's CEO talks frankly to IN VIVO about why the company needed to reorganize to bring its sales and marketing efforts, particularly in the US, up to the level of its technology development. Find out more...

Cartilage Repair: Bridging the Gap

Article preview reprinted Medtech Insight - May, 2009 

With the era of regenerative medicine upon us, fueled in part by the Obama administration's lifting of the ban on government funding for stem cell research, advancements in biological approaches to orthopedic joint restoration are in the forefront. Most orthopedic surgeons believe that the future treatment of musculoskeletal problems no longer lies in replacing joints with metallic implants but in the development of curative therapies involving cells, growth factors, and other bioactive agents capable of regenerating bone, cartilage, and other joint structures. Although such products are still in the early stages of development, there has been a recent surge of interest in this area. Based on the wealth of new technologies presented at this year's American Academy of Orthopaedic Surgeons meeting held recently in Las Vegas, it is clear that stakeholders in this industry are in hot pursuit of this opportunity, which could one day be measured in the billions of dollars. Find out more...

Abbott, Alcon, Bausch & Lomb Escape New FDA LASIK Advisory

• J&J Sale Of iBOT Wheelchair Begs Question Of Government Support
• Medtronic CEO Sees Firm Weathering Flood Of Recent Bad News
• Thermo Fisher Praised For Ability To Recover From Decline
• Boston Sci, J&J Rely On Old Stents To Create New Products
• Abbott, Alcon, Bausch & Lomb Escape New FDA LASIK Advisory
• Hologic Sued By Conceptus Over Contraception Device

Medtronic Gets FDA Approval For Pair Of Brain Stimulators

• Xtent To Fold After Failing To Attract Funds For Unique Stents
• Edwards Says Sapien Heart Valve Study Shows Better 30-Day Survival
• Medtronic Gets FDA Approval For Pair Of Brain Stimulators
• Medtronic Blasted By Senator For Omitting Key Name On Consultant List
• Abbott Says New Study Shows Xience Stent Better In Complex Cases

513(g) Device Classification Requests Drop; FDA Plans Guidance

Full article reprinted from "The Gray Sheet" - May 25, 2009

FDA's device center has seen a big drop-off in 513(g) requests since a new user fee put a hefty price tag on the voluntary product classification queries. Find out more...

Covidien buys Vnus Medical Technologies for $470mm cash

Deal summary reprinted from Strategic Transactions - May 2009

Covidien has acquired Vnus Medical Technologies, a company that markets minimally invasive devices to treat venous reflux disease, for $29 in cash per share (a 34% premium), or a total of about $470mm (more than four times its 2008 sales). It will become part of Covidien's medical devices unit. Find out more...

Device CEOs Who Find The Funding

Article preview reprinted from IN VIVO -  April, 2009   

The financial world may be in crisis, but top-tier medical device companies can still raise capital. But at what price? Four medical device execs answer those questions and many more.

PFO Closure: Where Do We Stand?

Article preview reprinted Medtech Insight - May, 2009 

The PFO (patent foramen ovale) closure market has certainly traveled a long and twisted road over the years. And the journey isn't over yet. Although some large companies have pulled back on their US commercialization efforts or decided to exit the field entirely, othrs continue to stick it out, hoping the eventual opportunity will far outweigh the risks and costs involved. In Europe, where percutaneous PFO closure following stroke/TIA is more widely accepted and performed, there are nine CE marked PFO closure devices available from eight different manufacturers, with two more devices expected to be added to the mix in the near future. But despite widespread European acceptance, manufacturers have so far failed to achieve the ultimate goal: US regulatory approval. Find out more...