Medical Devices Today

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.

Sekisui Chemical To Dissolve And Transfer Medical Device Subsidiary

Full translation summary from PharmAsia News - November 17, 2008

Find out how Sekisui Chemical announced Nov.13 the dissolution of Sekisui Medical Electronics, a medical device manufacturer subsidiary.

ESCRS: Zooming in on Vision Innovations

Article preview reprinted Medtech Insight - October 2008

Find out how at this year's meeting of the Congress of the European Society of Cataract and Refractive Surgeons, market leaders made headlines with news of joint ventures in refractive surgery, new product launches and re-launches, and other glimpses into the future of vision correction technology.

Zimmer Buys Abbott: Difficult Times Ahead in Spine

Article preview reprinted from IN VIVO - October 2008

If spine is such a promising market, why did Abbott sell its spine business to Zimmer?