Publisher's Spotlight: Introducing the Scantron TRaC II Digital SolutionNo 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.
Continue reading "How to Simplify Tracking of Patients with Implanted Medical Devices and Improve FDA Compliance" »
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...
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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...
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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...
Continue reading "ESCRS 2009: The Next Wave in Cataract and Presbyopia Devices" »
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...
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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...
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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...
Continue reading "AdvaMed Critical Of House Approach To Setting Minimum Benefits Package " »
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...
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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...
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