ControlRad announced today that it made several additions to its leadership team, naming a new chief financial officer, VP of U.S. operations, VP of marketing and two new VPs of sales. The Atlanta-based company named Peter Pizzo as its new CFO. Pizzo has more than 25 years of experience in senior financial roles, having previously […]
Imaging
FDA clears etectRx ingestible event marker
EtectRx this week announced that the FDA cleared its ID-Cap System ingestible event marker. The ID-Cap System is an ingestible event marker that transmits digital messages from within the body to an external receiver. EtectRx’s ID-Cap System features the ID-Capsule, ID-Tag, ID-Cap Reader and related software. It gives real-time dose-level ingestion event verification and the […]
Elekta wins FDA approval for diffusion-weighted images
Elekta (STO:EKTA B) today announced that it received FDA 510(k) premarket notification for its diffusion-weighted MR images from the Elekta Unity. The clearance allows the images to be interpreted by a trained physician. With the new FDA clearance, the system can be used for the biologic assessment of tumor response during therapy. Diffusion-weighted MR images (DWI) […]
Siemens Healthineers lands FDA clearance for two CT systems
Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom go.Open Pro computed tomography systems. The CT systems are designed for radiation therapy planning and are members of the company’s Somatom go. platform of devices. Get the full story on our sister site, Medical Design & Outsourcing.
ViewRay issues urgent field safety notice for MRIdian System Treatment Planning and Delivery System
ViewRay (NSDQ:VRAY) has issued a field safety notice for its MRIdian System Treatment Planning and Delivery System software. The urgent device correction stems from some cases where a dose that was previously administered to a patient may not be accurately registered with the daily scan. There have been no reports of patients affected by the issue. […]
Drug or device? FDA loses this argument for now
This article has been updated with comments from an attorney for Genus Medical Technologies. A federal judge has temporarily blocked an attempt by the FDA to regulate a barium sulfate product ingested before imaging as a drug. The decision counts as at least a partial win for Genus Medical Technologies (St. Louis), maker of the […]
Aurora Bio touts PET radiotracer data
Aurora Bio revealed data from the use of its AUR01 novel PET radiotracer for systemic amyloidosis that showed strong results in uptake and retention, but also experienced some adverse events. The synthetic peptide radiotracer is designed to bind many forms of amyloid, including AL, ATTR and ALECT2. Currently, no radiotracers are approved in the U.S. […]
MolecuLight wins FDA clearance for handheld imaging device
MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for detecting wounds containing bacteria. MolecuLight i:X is designed to enable real-time point-of-care visualization of fluorescence in wounds, while it measures wounds and digitally records images and measurements. It received FDA de novo clearance in August 2018. The device’s fluorescence […]
NOUS Imaging picks up $6.6m for brain-imaging software
NOUS Imaging announced that it picked up $6.6 million in venture capital and government research investments for its software-based biofeedback solution. The St. Louis, Mo.–based company is developing the Framewise integrated real-time MRI monitoring (FIRMM) system for acquiring better brain MR exams. FIRMM initially only worked with Siemens MR scanners, but NOUS Imaging said it […]
IntraVu raises $11.7m for tiny imaging system
IntraVu (Redwood City, Calif.) has raised nearly $11.7 million as it markets its tiny imaging system to doctors, according to a Form D recently filed with the SEC. The company’s single-use MIDAScope is a 1.4 mm high-definition video and photo camera on the tip of a needle. The scope, according to the company, disrupts less […]
Sectra and Leica seek FDA clearance for digital pathology solution
Sectra (STO:SECTB) and Leica Biosystems announced that they formed a partnership to collaborate in an effort to win FDA clearance for an integrated clinical pathology solution. The companies said their goal is to address the clinical needs of enterprise-level customers, including academic medical centers, clinical research organizations and large hospital networks. They have already submitted an […]