The Medical Device Business Journal — Medical Device News & Articles | MassDevice
U-Systems won a date with the FDA to review its pre-market application for the first ultrasound device indicated for breast cancer screening.
The somo.v Abus device, which is set to undergo agency review on April 11, 2012, is already FDA-cleared for diagnostic use as an adjunct to a mammogram.
SonoSite (NSDQ: SONO) said it’s replacing retiring CFO Marcus Smith with Anil Amlani, head of its VisualSonics subsidiary.
Smith’s last day as the ultrasound device maker’s top financial mind is today; he’s slated to stay on at the Bothell, Wash.-based company until Jan. 5, according to a press release.
Smith had been with SonoSite since 2007, according to the release.
Venture capital investment is on the wane, but angel investment is increasing, according to a pair of recent reports.
The University of New Hampshire’s Center for Venture Research reports that angel investment rose nearly 5 percent during the first and second quarters, to $8.9 billion, compared with the same period last year. Health care and medical device firms took the lion’s share of the angel cash (25 percent, according to the report), which usually comes from the proverbial "high net worth individuals" or in early-stage funding rounds.
It took more than eight months, but Mobisante’s mobile ultrasound offering is finally on the market in the U.S.
Mobisante won 510(k) clearance from the FDA in February, but it took the intervening months for the Redmond, Wash.-based company to ready its MobiUS device for commercialization here, co-founder and CTO David Zar told MobiHealthNews.
