Medical Devices Today

Six Firms Apply For FY 2010 New Technology Add-On Payments

Full article reprinted from "The Gray Sheet" - December 1, 2008

Find out how CMS has received four new applications for new technology add-on payments for fiscal 2010, plus two re-applications for devices that were considered last year.

Will FDA’s Risk Management Model For Drugs Migrate To Devices?

Full article reprinted from "The Gray Sheet" - December 1, 2008

FDA's device center may be moving toward imposing more risk management measures on moderate-risk devices, on the model of recent statutory risk management authorities for drugs, industry lawyers observe.

Harvard’s Maisel Builds An Institute To Spotlight, Explain Device Risks

Full article reprinted from "The Gray Sheet" - December 1, 2008

Find out how Harvard cardiologist William Maisel has been an important moderating voice during some of the device industry's most controversial moments in recent years.

MHLW Revises GCP For Medical Devices, Collects Public Comment

Full translation summary from PharmAsia News - November 24, 2008

Find out how the Food and Drug Affairs Bureau at Japan's Ministry of Health, Labor and Welfare revealed a draft of revisions to guidance for medical device good clinical practice.

Deal of the week: Valeritas brings in $50.6mm via private placement · November 2008

Deal summary reprinted from Strategic Transactions - November 2008

 

BioValve Technologies's Valeritas (insulin drug delivery systems) brought in $50.6mm, which includes $19.9mm in convertible debt, through a financing of both Series A and B preferred shares and warrants to Abingworth Management, MPM Capital, Pitango Venture Capital, and US Venture. Valeritas could raise up to $87mm in the round.

Deal summary reprinted from Strategic Transactions - November 2008

 

BioValve Technologies's Valeritas (insulin drug delivery systems) brought in $50.6mm, which includes $19.9mm in convertible debt, through a financing of both Series A and B preferred shares and warrants to Abingworth Management, MPM Capital, Pitango Venture Capital, and US Venture. Valeritas could raise up to $87mm in the round.

ESC Highlights: Imaging, Hypertension Devices Take Center Stage

Article preview reprinted Medtech Insight - October 2008

Find out how more than 30,000 delegates attended this year's European Society of Cardiology (ESC) Congress, held in September in Munich, Germany. The conference's imaging theme drew cardiologists from across the globe to packed sessions, and while drug-eluting stent (DES) results were a mixed bag, remote catheter navigation explored new frontiers, and emerging hypertension devices drew a lot of interest.

“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe

Full article reprinted from "The Gray Sheet" - November 24, 2008

Find out how FDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process.

CT Colonography Screening Shows Promise If Cost Lowered, MedCAC Says

Full article reprinted from "The Gray Sheet" - November 24, 2008

Find out how computed tomography colonography shows promise as a colorectal cancer screening tool comparable to optical colonoscopy, and could be covered under Medicare, but the price per procedure would have to be lowered, members of a CMS advisory panel agreed Nov. 19.

FDA Panel Success Puts ThermoCool First In Line For AF Ablation Indication

Full article reprinted from "The Gray Sheet" - November 24, 2008

Find out how Johnson & Johnson/Biosense Webster's Navistar ThermoCool saline irrigated radio-frequency ablation catheterhas the inside track to become the first ablation catheter with an FDA-approved indication for atrial fibrillation following a unanimous recommendation from the agency's Circulatory System Devices Panel.

Deal of the week: Cardiac Concepts gets $21mm through its Series B

Deal summary reprinted from Strategic Transactions - Otober 2008

Cardiac Concepts gets $21mm through its Series B

Find out how Medical device company Cardiac Concepts has raised $21mm through the closing of its Series B venture round.