CardioInsight chairman & CEO Steve Arless resigns, to be replaced by 2-man "office of the president"
AirXpanders
AirXpanders lands $10M for tissue expansion for breast reconstruction | Funding Roundup
Breast reconstruction technology company AirXpanders Inc. closed a $10 million Series D funding round to support its tissue expansion devices for breast reconstruction.
The Palo Alto, Calif.-based company plans to use the proceeds to advance investigational device exemptions studies, obtain CE Mark approval in Europe and execute market launches in the U.S., Europe and Australia following clearance of its AeroForm system.
BSX touts FDA nod for spinal cord lead | Regulatory Roundup
Boston Scientific Corp. (NYSE:BSX) landed FDA clearance for its Infinion 16 percutaneous lead, designed for use with the company’s Precision Plus spinal cord stimulator system to control chronic pain.
The Infinion 16 lead is the first 16-contact percutaneous lead on the global market, doubling the previous max of eight stimulating contacts, according to the Natick, Mass.-based med-tech titan.
Optos gains on Project Daytona FDA clearance | MassDevice.com Regulatory Roundup
Shares of Optos plc (LSE:OPTS) gained 6.4 percent after the company announced that the FDA granted 510(k) clearance in the U.S. for its Project Daytona retinal scanning device.
The British ophthalmology device maker’s stock closed at £1.62 today (about $2.64), up about 15 cents since August 25, the day before the clearance announcement, when OPTS shares closed at £1.52 ($2.49) on the London Stock Exchange.