Mela Sciences recalls its flagship MelaFind melanoma diagnosis system because some of its software wasn't included in its FDA approval.
Mela Sciences (NSDQ:MELA) recalled its flagship MelaFind melanoma diagnosis aid because some of its software wasn't included in its pre-market approval from the FDA.
Biotronik is launching a smartphone-like device in Japan designed to wirelessly transmit pacemaker and defibrillator data to patients' physicians and a refreshed line of MRI-safe ICDs that use the system.
Lumicell says it received approval from the FDA for a pilot feasibility study of its intraoperative breast cancer imaging system.
Lumicell Diagnostics said it won an investigational device exemption from the FDA for a pilot feasibility trial of its imaging system for breast cancer surgeries.
The study is slated to be conducted at the Mass. General Hospital in Boston, the company said.
The FDA sends its 3rd 'not approvable' letter to Guided Therapeutics over its pre-market approval application for the LuViva cervical scanner.
Philips says it inked a 5-year research alliance with the Mass. Institute of Technology and plans to move its North American research center to Cambridge, Mass.
Mauna Kea says it won CE Mark approval in the European Union for its Cellvizio imaging device in minimally invasive surgeries.
Data from a new study shows Biotronik’s Iforia ProMRI implantable cardioverter defibrillator is safe to use with 1.5T MRI scanners.
Biotronik's Iforia ProMRI implantable cardioverter defibrillator is safe for use in 1.5T MRI scanners, researchers announced today at the Heart Rhythm Society's annual meeting in Boston.