Category: ImagingSyndicate content

Imaging

Mela Sciences recalls MelaFind

May 27, 2015 by Fink Densford

Mela Sciences recalls its flagship MelaFind melanoma diagnosis system because some of its software wasn't included in its FDA approval.

Mela Sciences recalls MelaFind device

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 launches home CRM monitoring, MRI-safe devices in Japan

May 26, 2015 by Mark Hollmer

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.

Biotronik launches home CRM monitoring, MRI-safe devices in Japan

Lumicell receives FDA nod for feasibility trial

May 22, 2015 by Fink Densford

Lumicell says it received approval from the FDA for a pilot feasibility study of its intraoperative breast cancer imaging system.

Lumicell receives nod from FDA for feasibility trial

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.

FDA denies Guided Therapeutics again

May 20, 2015 by Brad Perriello

The FDA sends its 3rd 'not approvable' letter to Guided Therapeutics over its pre-market approval application for the LuViva cervical scanner.

FDA issues 3rd denial of Guided Therapeutics' LuViva

Philips inks 5-year, $25m research deal with MIT

May 20, 2015 by Fink Densford

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.

Philips inks 5-year, $25m research deal with MIT, moves R&D to Cambridge, Mass.

Mauna Kea wins expanded CE Mark for Cellvizio

May 20, 2015 by Fink Densford

Mauna Kea says it won CE Mark approval in the European Union for its Cellvizio imaging device in minimally invasive surgeries.

Mauna Kea wins expanded CE Mark for Cellvizio

HRS 2015: Biotronik’s Iforia ICD safe for MRI

May 15, 2015 by Fink Densford

Data from a new study shows Biotronik’s Iforia ProMRI implantable cardioverter defibrillator is safe to use with 1.5T MRI scanners.

HRS 2015: Biotronik’s Iforia ICD safe for MRI

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.