MASSDEVICE ON CALL — Mela Sciences (NSDQ:MELA) is on a roll this month, receiving an "approvable letter’ from the FDA just weeks after winning CE Mark approval in the European Union for its handheld skin cancer detector, MelaFind.
MELA shares shot up to $6.00 in early morning trading today, an 89 percent hike on yesterday’s close at $3.18. Shares had settled down to about $5.36 by mid-morning, still a 68 percent spike from yesterday.
The progress toward FDA clearance is a "monumental milestone" for Mela Sciences, which is more than two years into a six-month review of its premarket approval application for MelaFind.
"We’re collateral damage in the efforts to re-design the 510(k) program," Gulfo told MassDevice in June.
Earlier this month the European Union granted CE Mark approval for the device, clearing it for the markets in 27 countries overseas.
Diabetes devices for dogs
Menarini Diagnostics’ continuous blood glucose monitor, tested in ten dogs, revealed that none were getting proper insulin treatment, although one dog did lose its monitor in the course of a fight, according to a press release.
Heart of gold: Gold nanowires may improve tissue repair after heart attack
Using tiny gold wires to engineer cardiac patches may help heart attack patients by making tissue patches electrically conductive, according to a press release.
Speech recognition leads to higher error rates in breast imaging
Breast imaging reports generated using automatic speech recognition were six times more likely to contain major errors, according to a press release.