More ITEM Japan News | Fujifilm Expands | FDA Gets Tough

FDA Clears Siemens Somatom Force CT Scanner
Siemens Healthineers continued its Somatom lineup update, announcing the FDA clearance of its flagship Somatom Force CT dual source scanner, roughly six months after debuting at RSNA. Like the new mid-range Somatom Edge Plus, the new Somatom Force leads with Siemens’ FAST integrated workflow and FAST 3D Camera, which helps correct patient positioning, reduces noise, lowers radiation dosage, and potentially eliminates repeat scans.

 

Shimadzu Updates Trinias Angiography Series
Shimadzu announced the launch of the Trinias unity smart edition angiography series. The new series includes the C12, C16, and F12 Trinias unity smart edition models (C= Ceiling Mount, F=Floor) for whole body intravascular treatment. The new models add an updated UI that shows all necessary info on the main monitor and adds a standard SMART Touch console for more intuitive operation. The new Trinias models also achieve space savings by reducing connecting cables and system cabinets and add Shimadzu’s SCORE StentShot technology to reduce noise when viewing therapeutic devices, like stents.

 

Fujifilm USA Enters Minimally Invasive Surgery Market
Fujifilm USA entered the minimally invasive surgery market with the launch of two surgical visualization systems. The new Ultra-Slim Video Laparoscope System and Full High Definition Surgical Visualization System were developed by the company’s new Boston-based FUJIFILM New Development subsidiary. The new systems are part of Fujifilm’s strategy to expand its minimally invasive portfolio, including future products for more sophisticated surgeries.

 

FDA Targets Cybersecurity Improvements
The FDA’s new “Medical Device Safety Action Plan” placed a clear target on device cybersecurity. The administration asked congress for expanded funding and authority to improve its cybersecurity-related activities, requesting approval to create a new CyberMed Safety Analysis board. The FDA may also require that device makers build in a capability to update and patch device security into product design, including as part of premarket submissions.

 

Fourth Wave of ITEM Show Announcements Hit Japanese Press
The ITEM show in Japan came to a close this week with a fourth (and likely final) wave of product launches from Canon, Fujifilm, Hitachi, and Toyo, including a number of products making their first worldwide appearance that may precede expansions to Western markets.

  • Canon Medical Systems announced the launch of the Alphenix Core + and Alphenix Biplane X-ray angiography systems, offering improvements to image quality, workflow, exposure, and catheter treatment support. The new models are expected to expand globally, possibly replacing Canon’s current Infinix-i Core+ and Biplane systems.
  • Canon Medical Systems Japan started selling its new AiCE (Advanced Intelligent Clear – IQ Engine) CT reconstruction technology, intended for use with the Aquilion Precision CT scanner, reducing noise and allowing high-quality images at a lower dose.
  • Fujifilm Japan launched Comfort Comp, a mammogram option that automatically controls pressure reduction to improve patient comfort.
  • Fujifilm Japan signed a partnership with medical image analysis software group, LPixel (part of U of Tokyo), adding diagnostic AI technology to Fujifilm’s PACS system.
  • Hitachi Japan released the Scenaria View 64-row multi-slice CT system, featuring an 80cm wide opening (vs. 75cm), and adding Hitachi’s IPV image reconstruction solution, which improves chest resolution at an unchanged dose versus its predecessor. The new CT scanner is currently limited to Japan, but will likely expand to other regions.
  • Toyo Protechnica will offer its ClearRead XR X-ray image enhancement technology with NOBORI’s Pal PACS system as part of a new chest X-ray bone tissue penetration and temporal difference cloud service in Japan.

 


The Wire

  • Medtronic’s Visualase MRI-guided laser ablation system received CE mark approval, allowing the neurosurgery system to sell in Europe nearly 11 years after achieving FDA clearance in the US.
  • Sectra launched a nationwide telepathology solution in the Netherlands through a partnership with Dutch Society for Pathology (NVVP) and Foundation PALGA, making images and reports available to the country’s pathology labs.
  • Healthcare Administrative Partners launched its new Deep Dive Analytics Service, including a new “incidental findings module” that uses algorithms to identify patients who require a follow-up evaluation and a “practice productivity and quality maximization module” that identifies opportunities for care and operational improvements.
  • Densitas receives FDA 510(k) clearance for its DENSITAS|density automated breast density software, integrating with PACS systems to provide radiologists with breast density assessments at the point-of-care.
  • According to research from UC San Francisco, machine learning could soon be a common way to diagnose SCI neurological damage following a spinal cord injury.
  • A JACR editorial, citing Johns Hopkins research, suggested that radiologists perform risk-benefit analysis before using gadolinium-based contrast agents (GBCAs) due to associated health risks, particularly warning against repeat scans for children, pregnant woman, and patients sensitive to contrast agents.
  • CIVCO Radiotherapy announced a partnership with Adaptiiv, allowing the company to distribute Adaptiiv’s software used to 3D print patient-specific radiotherapy bolus or applicators.
  • The Centers for Medicare & Medicaid Services (CMS) finalized its plan to cover MRI scans for patients with implanted cardiac devices and expanded its coverage beyond MRI-conditional devices, revealing that it will provide reimbursements for MRI procedures on patients with these devices.
  • Global Market Insights forecasts that the healthcare AI market will maintain a 40% CAGR between 2017 and 2024 to more than $10 billion, due to the growing use of big data, greater adoption of precision medicine, and developments in AI drug discovery and medical imaging applications.

The Resource Wire

 

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