Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or suspected cardiac shunt. The agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of […]
Imaging
Metallic hydrogen could be a reality: Why you should care
Harvard University scientists say they have created metallic hydrogen, a super material that until now has only been theoretical. If the claims pan out, they could open up a host of possibilities, including in the medical device field. That’s because metallic hydrogen theoretically should be superconductive at room temperature. MRIs, for example, would no longer […]
Varian Medical closes $600m Varex Imaging spinout
Varian Medical (NYSE:VAR) today announced it successfully completed the $600 million spin-out of its imaging components biz, Varex Imaging (NSDQ:VREX). Salt Lake City, Utah-based Varex Medical said that common stock in the company will begin trading in the “regular way” today on the Nasdaq Global Select Market under the symbol “VREX.” “We are very pleased that we […]
Covidien spinout Mallinckrodt closes $690m sale of nuclear imaging biz
Covidien spinout Mallinckrodt plc (NYSE:MNK) said today that it closed the $690 million sale of its nuclear imaging business to IBA Molecular. Mallinckrodt’s nuclear imaging business includes 2 manufacturing facilities and more than 800 employees. The $690 million deal, which was announced in August last year, consists of Mallinckrodt’s portfolio of diagnostic imaging products, including medical isotope […]
This AI can spot skin cancer as well as doctors
Stanford University researchers say that they’ve trained a deep learning algorithm to identify skin cancer as well as dermatologists. The researchers pitted the artificial intelligence against 21 board-certified dermatologists when it came to diagnosing skin lesions. The deep convolutional neural network’s performance was on par with the experts when it came to spotting the most […]
Neural Analytics wins CE Mark for next-gen Lucid transcranial ultrasound
Neural Analytics said today it won CE Mark approval in the European Union for its next-gen Lucid M1 transcranial doppler ultrasound system. The Los Angeles-based company’s Lucid M1 is a portable all-in-one ultrasound system designed for rapid triaging and monitoring of patients with brain disorders. “The development of accurate and portable brain monitoring technology like […]
7D Surgical wins FDA, Health Canada nod for spinal surgical guidance system
Canadian medical device firm 7D Surgical said today it won FDA 510(k) and Health Canada clearance for its machine-vision image guided 7D Surgical navigation system designed for spinal procedures. The Toronto-based company’s surgical system uses 3D optical technologies which require only natural light, as well as machine vision algorithms. 7D Surgical touted the system as […]
Varian Medical’s components spinout, Varex Imaging, begins public trading
Shares in Varex Imaging (NSDQ:VREXV), the $600 million components business spun out of Varian Medical (NYSE:VAR), hit the market last week for their 1st day of public trading. Stock in Salt Lake City-based Varex debuted Jan. 20 at $28 apiece, hitting a high of $28.50 before closing up 0.5% at $28.15 per share. Varian said earlier this month that it expects […]
Health Canada approves Fujifilm’s Vevo HD ultra-high-frequency ultrasound device
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 […]
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 […]