Devices & Diagnostics

Edwards Lifesciences, Mela Sciences get FDA nods (Morning Read)

Current medical news from today, including Edwards Lifescience’s Sapien transcatheter aortic heart valve approved, as is Mela Sciences’ melanoma screening device, and a tiny continuous glucose monitor nabs $54M in fundraising.

Current medical news and unique business news for anyone who cares about healthcare.

A less invasive aortic heart valve replacement. A cutting-edge artificial aortic heart valve that can be implanted without major surgery, especially appropriate for elderly patients who are too old for the invasive method currently used, has been approved by the FDA. Edwards Lifesciences’ Sapien can be inserted in the leg and threaded into place through a major artery.

New melanoma screening. The FDA also announced Wednesday that it approved Mela Sciences’ MelaFind, a device to scan skin growths that lack obvious signs of cancer but have at least one worrisome characteristic. The device makes detailed, digital images and uses a computer to analyze them for signs of skin cancer.

$54M for a continuous glucose monitor. A company developing a penny-sized implantable glucose monitor nabbed $54 million in its fourth round of funding. Sensors for Medicine and Science says it will use the funding for product development and regulatory approval of its device, which is implanted under the skin and used along with a watch-like display to deliver readings every few minutes for up to six months.

The FDA wants you! The regulatory agency has opened a 60-day public comment period on the efficacy of its medical device labeling system.

More fundraising = more attractive for a purchase? Venture and private-equity backed companies are raising more money before being acquired, according to a new study from Shareholder Representative Services. Companies today go through an average of 3.57 rounds of preferred stock financing, compared to the 2.8 rounds averaged in 2008.