Medical Devices Today

How to Simplify Tracking of Patients with Implanted Medical Devices and Improve FDA Compliance

Publisher's Spotlight: Introducing the Scantron TRaC II Digital Solution

No one knows better than device manufacturers just how difficult it can be to keep track of patients with implantable medical devices, much less reach them and their doctors in event of a recall. And yet that is exactly what the FDA’s medical device tracking guidelines require. They specify that manufacturers of certain devices establish and maintain a written standard operating procedure related to tracking devices, quality control, and audit procedures.

And when an FDA recall does occur, device manufacturers have just a few days to notify patients and doctors. The resulting frenzy can cost the unprepared business millions and may yield large FDA fines. Add the likelihood of bad press or the threat of lawsuits and compliance, executives face significant challenges.

PhotoMedex privately sells 4.17mm common shares

Deal summary reprinted from Strategic Transactions - November 2009

PhotoMedex (lasers for dermatological use) has raised $2.7mm through the private sale of 4.17mm common shares at $0.65 each (a 6% discount) to accredited investors. Read more...

Venture Capitalists Advise Device Companies to Run Lean

Article preview reprinted from Start Up - October/November 2009

Venture capitalists speaking at the Medtech Insight IN3 Medical Device Summit in San Francisco in October stressed that they need to know how much capital a company will need to break even or turn a profit. Read more...

ESCRS 2009: The Next Wave in Cataract and Presbyopia Devices

Article preview reprinted from Medtech Insight -September/October 2009

The 2009 Congress of the European Society of Cataract and Refractive Surgeons and Presbyopia International 2009 Symposium took place against a backdrop of relative optimism within the refractive surgery industry. There are signs that the laser vision correction market may have hit bottom during the middle of 2009. Read more...

Asthmatx Positive Panel Outcome Good Sign for Pulmonology Companies

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

The FDA's Anesthesiology and Respiratory Device Panel delivered good news to the interventional pulmonology sector by issuing a positive recommendation for Asthmatx Inc.'s Alair Bronchial Thermoplasty System, a treatment for severe asthma. The positive news came nearly a year after the same panel voted not to recommend Emphasys Inc.'s lung airway valve as a treatment for emphysema. Read more...

Zimmer Gets Negative Response From FDA Panel On Spine Device

 

Medtronic, Guidant Heart Stabilizers Judged Superior Heart Devices

St. Jude Quits AdvaMed Over Health-Reform Taxing Principles

“Medtronic Begins Global Testing Of Attain Series Of Implanted Devices

Covidien Completes $210 Million Takeover Of Aspect Medical Systems

Thermo Fisher, Inverness End Diagnostics Distribution Agreement

Sonova Agrees To $489 Million Takeover Of Advanced Bionics

Boston Sci, J&J Original Stents Fractured In Nearly Third Of Cases

Stryker CEO Questions Marketing Practices Of Would-Be Targets

GE Healthcare Refines Portable ECG For Rural Asia Areas

J&J CEO Sees More M&As Result From Proposed Device Firm Taxes

 Edwards CEO Says Agrees With St. Jude Health Care Tax A Fact

Smith & Nephew Offers $21 Million For Wound-Care Maker Nucryst Assets

Zimmer Gets Negative Response From FDA Panel On Spine Device

Medtronic, Guidant Heart Stabilizers Judged Superior Heart Devices

St. Jude Quits AdvaMed Over Health-Reform Taxing Principles

“Medtronic Begins Global Testing Of Attain Series Of Implanted Devices

Covidien Completes $210 Million Takeover Of Aspect Medical Systems

FDA Is Expanding Transparency Efforts To Focus On Industry Questions

Full article reprinted from "The Gray Sheet" - November 16, 2009

FDA has expanded its transparency initiative to cover an area that was unanticipated, Deputy Director Joshua Sharfstein said: explaining how the agency works to the industry it regulates. Read more...

AdvaMed Critical Of House Approach To Setting Minimum Benefits Package

Full article reprinted from "The Gray Sheet" - November 16, 2009

A provision in the recently passed House health care reform bill designed to define qualifying requirements for a health plan to be included in a new national insurance exchange would give too much power to the government over use of devices, industry reps say. Read more...

FDA Victory In Civil Money Penalty Case Could Signal More To Come

Article preview reprinted from "The Gray Sheet" - November 16, 2009

A federal appeals court decision upholding $340,000 in civil money penalties against TMJ Implants for adverse event reporting violations may "embolden" FDA to impose money penalties more often, attorneys familiar with the device industry say. Read more...

Biomet buys biomaterials fim Cartilix

Deal summary reprinted from Strategic Transactions - October 2009

Reconstructive device firm Biomet is acquiring fellow private company Cartilix (biomaterials) for an undisclosed amount. Read more...