Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for its Acuity X4 quadripolar leads for its cardiac resynchronization devices. The approval marks the 1st time the Marlborough, Mass.-based company has a full quadripolar CRT system on the U.S. market. The Acuity X4 leads are designed to work with Boston’s Dynagen X4 and […]
Imaging
Clear Guide Medical wins 510(k) for Scenergy image guidance
Clear Guide Medical said today it won FDA 510(k) clearance for its Scenergy CT-Ultrasound fusion and image guidance system designed to aid in minimally invasive biopsies and other diagnostic and therapeutic procedures. The system operates through an intelligently integrated display of fused ultrasound and CT images, and will be sold as an accessory to ultrasound […]
St. Jude Medical launches Optis Mobile in Europe, Japan
St. Jude Medical (NYSE:STJ) said today that it’s launching its Optis Mobile OCT-FFR lab in Europe and Japan. Little Canada, Minn.-based St. Jude said the portable Optis Mobile is designed for hospitals with multiple cardiac catheterization labs and combines optical coherence tomography and angiography co-registration with fractional flow reserve. “The Optis Mobile system represents the ongoing commitment of […]
Philips, BTG tout 1st live-imaging embo bead procedure
Royal Philips (NYSE:PHG) and BTG said today the 1st patient has been treated by a live-image guided LC Bead Lumi in a treatment aiming to block blood flow to a hypervascular tumor in a patient with liver cancer. BTG’s LC Bead Lumis are embolic beads which can be visualized during interventional procedures to allow operating […]
Toshiba bails on non-imaging healthcare biz
Toshiba (TYO:6502) said today that it’s planning to ditch or transfer all of its healthcare business that’s not a part of Toshiba Medical Systems, its imaging division, and forecast higher losses for the rest of the year. A bidding war for Toshiba Medical is heating up among a slew of private equity players and rival corporations, as the Japanese industrial […]
Philips issues urgent safety notice for Allura systems
Royal Philips (NYSE:PHG) issued a set of field safety notices for its Allura Xper system, including the FD, Centron, Clarity and CV20 models over issues with failing alarms and unexpected system movements. The Integris Allura Xper system is designed for cardiovascular and vascular X-ray imaging applications as well as interventional procedures such as percutaneous transluminal coronary […]
LifeImage picks up mammography medical exchange network Mammosphere
LifeImage said today it picked up national mammography and women’s imaging medical exchange network Mammosphere for an undisclosed amount. The acquisition will open up Mammosphere’s existing network, which allows healthcare providers and patients access to prior mammograms, to all healthcare providers currently using LifeImage’s own platform, the company said. “The availability of prior mammograms is critical […]
Advanced Medical Isotope hires IR firm Circadian Group
Advaned Medical Isotope Corp said Wednesday it hired medical device, pharma and biotech-focused investor relations firm Circadian Group. Newly-retained Circadian group will focus on presenting AMIC’s past success, current corporate profile and future catalysts to potential international investors. “Circadian Group is an excellent fit for AMIC. Circadian’s expertise in our industry at our stage of development, […]
Sales and profits slide for GE Healthcare
General Electric (NYSE:GE) said today that sales and profits in its GE Healthcare division slid for both the 4th quarter and full-year 2015, as the industrial conglomerate’s overall sales missed expectations, sending share prices down today. GE Healthcare posted profits of $938 million on sales of $4.97 billion during the 3 months ended Dec. 31, 2015, […]
China’s Neusoft launches NeuSight PET/CT device
Chinese medical device manufacturer Neusoft Medical Systems said yesterday it launched its NeuSight PET/CT scanners globally. Neusoft said its NeuSight PET/CT device won FDA approval in the U.S. and won CE Mark approval in the European Union in 2015. The newly launched device offers high quality diagnostic images with fast post processing speeds, the company said. […]
FDA: Brainlab Cranial IGS system recall is Class I
The FDA today labeled a recall of Brainlab’s Cranial image-guided surgery system as a Class I recall over issues with potential inaccuracies in the navigation display. The federal watchdog labeled the recall as a Class I, the most serious type of recall issued by the FDA, which indicates “there is a reasonable probability that use of […]