Medical Devices Today

Social Media Offer Many Benefits To Companies, But Caution Is Urged

Full article reprinted from "The Gray Sheet" - September 28, 2009

Social media sites like Facebook and Twitter can serve as an invaluable marketing resource for medical device and drug companies, but as FDA works to develop guidance on the issue, companies should be careful to control the content of their Web postings, marketing experts caution. Read more...

Proposed Rule Defines Good Manufacturing Practices For Combo Products

Article preview reprinted from "The Gray Sheet" - September 28, 2009

FDA released its long-awaited proposed rule on good manufacturing practices for combination products Sept. 22. Read more...

Internal FDA Menaflex Investigation Finds Serious Process Deviations

Article preview reprinted from "The Gray Sheet" - September 28, 2009

An internal evaluation of FDA's handling of the controversial 510(k) clearance of a knee implant unearthed serious shortcomings in the integrity of the agency's review process, FDA said Sept. 24. Read more...

Abbott, Medtronic Stents Beat Boston-Scientific’s Over Three Years: Study

Abbott, Medtronic Stents Beat Boston-Scientific’s Over Three Years: Study

Medtronic Payments To University Surgeon Face Wider Senate Probe

Boston Scientific Makes Limited Release Of Updated iLab Ultrasound

Edwards Expands Heart Valve Trial To Study Additional Risk Reduction

Hologic Gets U.S. Military Contract To Supply $28 Million In Devices

Edwards, Boston Scientific, Medtronic, J&J Targets Of Senate Probe

J&J Gets FDA Approval For Smaller Version Of Cypher Stent

Covidien To Trim 70 Jobs At Nebraska Plant In Restructuring Move

Covidien Completes Sale Of Sleep Diagnostics To Embla Systems

Bayer Gets FDA Approval For Diabetes Monitor That Plugs Into PC

Abbott Lab, Boston Sci, Medtronic To Report On Heart Stent Studies

Abbott Gets FDA Clearance For HIV Screening Test

Abbott, J&J, Others Could Be Under FDA Pressure For Diabetes Monitors

Zimmer, DePuy, Biomet Indiana Orthopedics Firms Oppose Health Plans

Calypso's latest venture round brings in $50mm

Deal summary reprinted from Strategic Transactions - September 2009

Calypso Medical Technologies (implantable devices for tumor localization and monitoring) raised $50mm through a venture round co-led by founding backer Frazier Healthcare Venture and new investor Skyline Ventures.

A Conversation With SAGES President, C. Daniel Smith, MD

Article preview reprinted from Medtech Insight - July/August 2009

C. Daniel Smith, MD, recently sat down with Medtech Insight to discuss trends in minimally invasive surgery and the single-incision laparoscopic approach. Smith is the current president of the Society of American Gastrointestinal Endoscopic Surgeons (SAGES), and professor of surgery and chair of the surgery department at the Mayo Clinic, Jacksonville, FL. Read more...

TransEnterix: Managing Revolutions in Surgery

Article preview reprinted from IN VIVO archives -  May, 2009 

Minimally invasive surgery, performed through a number of ports to create access and enable visualization, manipulation, and dissection, promised to revolutionize surgical techniques two decades ago, but ultimately fell short of changing the way surgeons perform the majority of surgical cases. Now, the next generation in minimally invasive surgery sees single-port surgeries and natural orifice transluminal endoscopic surgeries (NOTES) gaining momentum. TransEnterix aims to operate in both cases, with a novel approach that not only allows surgeons greater dexterity in performing complex procedures, but also enables them to do surgical cases through a single access port, using the body's umbilicus. Read more...

Japan Rolls Out Three-Tiered Review System For Medical Devices

Full article reprinted from "The Gray Sheet" - September 21, 2009

Japan is rolling out a new three-track medical device review system based on the novelty of the product, Japanese device reviewers said last week. Read more...

Combination Product Rules Clear OMB, To Be Released In Weeks

Article preview from "The Gray Sheet" - September 21, 2009

Two key proposed rules from FDA's Office of Combination Products have finally received Office of Management and Budget approval and should be out for comment in the coming weeks, according to OCP Director Thinh Nguyen. Read more...

Device Firms Dig In Against Baucus Fee, Despite Class I, Revenue Exceptions

Article preview reprinted from "The Gray Sheet" - September 21, 2009 The device industry lobbying machine has accelerated in opposition to Sen. Max Baucus' plan for a $40 billion fee on manufacturers in the lead up to Finance Committee health reform mark-up sessions this week. Read more...