Fujifilm Sonosite Inc. subsidiary Fujifilm VisualSonics Inc. said today that it won approval from Health Canada for its Vevo Med ultra-high-frequency clinical ultrasound device. The device operates at frequencies that are higher than conventional ultrasound devices, enabling healthcare professionals to see sonograms with image resolution down to 30 micrometers. “Throughout its history, Fujifilm has been […]
Imaging
Abbott launches St. Jude Medical’s Ensite Precision cardiac mapping
Abbott (NYSE:ABT) yesterday said it launched the EnSite Precision cardiac mapping system it acquired when it paid $25 billion for St. Jude Medical earlier this month. The commercial launch also included the sensor-enabled Advisor FL circular mapping catheter, Abbott said. The system, which won 510(k) clearance from the FDA in December 2016, was used for […]
Bracco Diagnostics wins another FDA nod for Lumason microspheres
Bracco Imaging U.S. subsidiary Bracco Diagnostics said today that it won FDA approval for its Lumason microsphere contrast agent to be used in ultrasonography of the urinary tract in pediatric patients with suspected or known vesicoureteral reflux. “The approval of Lumason for voiding ultrasonography answers an unmet medical need for an effective imaging study to […]
FDA warns on MRI risks with infusion pumps
The FDA issued a warning today that the strong magnetic fields used in an MRI exam can affect implantable infusion pumps. The federal watchdog has received reports of serious adverse events, including patient death, associated with using an infusion pump in an MR environment. The reports claim that some patients have experienced inaccurate medication dosing […]
Arterys wins 510(k) clearance for medical imaging analytics software
Arterys said today that it won 510(k) approval from the FDA for its Cardio DL medical imaging analytics software for cardiac MRI images. The San Francisco-based company said its software leverages cloud computing and “deep learning” to provide blood flow information based on conventional cardiac MRI images. “Arterys is committed to broadly accelerate the transformation […]
FDA clears next-gen Sonablate prostate device from SonaCare
SonaCare Medical said today that it won 510(k) approval from the FDA for the latest version of its high intensity focused ultrasound prostate tissue ablation device. The Sonablate device was the 1st of its kind to receive regulatory approval for the focused ablation of prostate tissue, according to SonaCare. The next-gen version features a tool […]
Varian Medical details Varex Imaging components spinout
Varian Medical (NYSE:VAR) said today that its board of directors approved the $200 million spin-out of the stand-alone Varex imaging components business and released more information on the distribution of Varex shares. The Palo Alto, Calif.-based company’s new spin-out will be separated through a tax-free distribution of shares, with each Varian stockholder receiving 0.4 shares of Varex […]
Avinger shares drop on Q4 prelims
Avinger (NSDQ:AVGR) saw shares prices drop -12% today after it released preliminary financial results for the 4th quarter, missing analysts’ expectations on Wall Street. The Redwood City, Calif.-based company said it expects a total revenue of $4.7 million, up 62% over Q4 2015 but down -11% from the 3rd quarter. Revenue from disposable devices is expected to be $3.7 million, […]
Exact Imaging raises $16m in Series C to support ExactVu micro-ultrasound
Micro-ultrasound developer Exact Imaging said today it raised $16.3 million (CDN $21.5 million) in a Series C funding round, with funds slated to support the commercialization of its ExactVu micro-ultrasound system. The round, which closed late last year, was led by Lumira Capital and Vesalius Biocapital and joined by newly invested PMV and previously invested iGan […]
Nikon’s Optos, Google’s Verily ink deal for machine learning in retinal imaging
Nikon (TYO:7731) subsidiary Optos and Google (NSDQ:GOOG) unit Verily inked a deal this week to develop technologies for machine learning-enabled retinal imaging. The deal calls for the companies will collaborate on improving the screening for diabetic retinopathy and diabetic macular edema, both among the leading causes of blindness worldwide. The program combines Nikon’s leadership in optical engineering and precision […]
The future of cardiac MRI: 3D cine
The heart is a dynamic, beating organ, and until now it has been challenging to fully capture its complexity by magnetic resonance imaging (MRI). In an ideal world, doctors could create a 3-D visual representation of each patient’s unique heart and watch as it pumps, moving through each phase of the cardiac cycle. Andrew Powell, […]