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, […]
Imaging
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 […]
UPDATE – Preventing superbugs: FDA clears redesigned Olympus endoscope
Updated to include information from Olympus. The FDA today said it cleared a redesigned version of Olympus‘ (TYO:7733) TJF-Q180V duodenoscope, with modifications intended to reduce the risk of bacterial infections. The company said it won new 510(k) clearance for the TJF-Q180V model, for modifications to both the design and labeling of the device. The redesigned […]
Imricor wins CE Mark for MR-conditional recording system
Imricor Medical Systems said today it won CE Mark approval in the European Union for its Advantage-MR EP recorder/stimulator system, designed to allow for MRI-guided electrophysiology procedures. The system, along with MR-compatible ablation catheters, will allow operating physicians to perform cardiac ablations using real-time MRI guidance, which the Minneapolis, Minn.-based company said could improve safety […]
Conavi wins 510(k) for cardiac ultrasound imager
Conavi medical said today it won FDA 510(k) clearance for its Foresight ICE System designed for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy. The device from Toronto-based Conavi, formerly known as Colibri Technologies, also allows for the visualization of other devices in the heart and great vessels of patients, the company […]
Lantheus sells Canadian radiopharmacy biz for $9m
Lantheus Medical Imaging said yesterday it sold its radiopharmacy and Canadian Gludef manufacturing and distribution businesses to Isologic Radiopharmaceuticals for $9m. As part of the sale, Lantheus and Isologic inked a long-term supply deal which positions Lantheus to supply Isologic with its products on commercial terms, with a set of product purchase commitments included. “We […]
iCad closes VuComp cancer portfolio buyout
iCad (NSDQ:ICAD) said today it completed its acquisition of VuComp’s cancer detection portfolio, including the M-Vu computer aided detection technology platform. The buy includes a library of related clinical data as well as VuComp’s key personnel and existing customer base. iCad had previously acquired VuComp’s M-Vu breast density software product in April last year. “This […]
Boston Scientific launches LithoVue 1-use ureteroscope
Boston Scientific (NYSE:BSX) said today it launched its LithoVue single-use digital flexible ureteroscope designed for minimally invasive endoscopic procedures such as diagnosing and treating stones and other kidney, ureter and bladder conditions. The single-use scope is designed to be cost-effective compared to multi-use scopes which require maintenance, sterilization and reprocessing, as well as other operational and financial challenges, […]
Fujifilm wins CE Mark for Vevo MD UHF ultrasound
Fujifilm Sonosite (TSE:4901) subsidiary VisualSonics said today it won CE Mark approval in the European Union for its Vevo MD ultra high frequency clinical ultrasound. The Vevo MD operates at higher frequencies than conventional ultrasound systems currently on the market, Fujifilm said, and is now commercially available in the majority of the European Union countries. “As […]
Good early data for Lumicell’s tumor-detecting system
An early trial of Lumicell’s surgical imaging agent returned promising results, according to findings published Wednesday in Science Translational Medicine. Lumicell’s surgical imaging system is made up of a hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent, the company said. The technology is designed to be optimized for specific cancer-types and surgical […]