Image Ownership | CAD Class II | Olympus & Hitachi’s Ultrasound

“Right now, as the law defines it, your medical images are property of the health system . . . You don’t own the image.”

– Johns Hopkins Medicine’s director of radiology, Dr. Karen Horton, addressing the debate over whether patients own medical images taken of their bodies, a potentially hot issue given the growth of AI imaging studies and the current focus on personal privacy and permission.

The Imaging Wire

FDA Eases Regulatory Path for Image Analysis Software
The FDA announced plans to reclassify “medical image analyzers” to Class II, down from Class III, easing the regulatory process for computer-assisted detection (CAD) devices. Once finalized, developers will no longer have to submit premarket approval applications (PMA) for these products and will instead file an easier 510(k) premarket notification in order to commercialize their device. The list of reclassified CAD solutions includes: mammography for breast cancer, ultrasound for breast lesions, radiographic imaging for lung nodules, and radiograph dental caries detection devices. This move seems reasonable given that CAD products do not pose a risk comparable to other Class III products (e.g. stents, pacemakers, breast implants) and is somewhat expected following the FDA’s reclassification of other computer-related imaging analysis solutions last year and given the FDA’s increasingly AI-friendly philosophy.


When Your Images Aren’t Yours
NPR’s All Things Considered introduced a much wider audience to the healthcare AI conversation last week. The popular drive time show (14.7 daily listeners!) questioned if patients should have a say in whether their medical data is used in AI studies and whether they are owed a share of the profits when their data contributes to the development of commercial products. The descendants of Henrietta Lacks may have some thoughts on this. The report placed a major focus on medical imaging AI studies, citing a recent Emory University paper on patients’ rights to their own medical images and a separate Johns Hopkins study that uses a database of anonymized CT scans to develop a new way to diagnose pancreatic cancer. US legal precedent is clear that patients do not own their cells, data, or images once in hospital hands, and most institutions go a step further by having patients sign-off on the use of their data for research during the hospital admission process. However, the message from last week’s radio story is that this precedent may be subject to increased scrutiny going forward. If you consider how much of a hot-button issue data permission and privacy is (and not just healthcare due to Facebook, Google, etc) it’s likely we haven’t heard the last of this debate.


Olympus and Hitachi Partner for ARIETTA 850 Endoscopy Ultrasound
Olympus and Hitachi Healthcare Americas announced the availability of Hitachi’s 6-month-old ARIETTA 850 premium endoscopy ultrasound through Olympus’ endoscopy-focused sales channel. The ARIETTA 850 is compatible with Olympus’ range of endoscopes, allowing physicians to view all five layers of the GI tract (vs. only the inner linings with traditional endoscopy), and either joins or replaces the Hitachi-made ProSound F75 ultrasound in Olympus’ limited ultrasound lineup. Hitachi has operated endoscope ultrasound and channel partnerships with both Olympus and Pentax for years and this launch appears to represent a continuation of this strategy, but not necessarily a significant change in its relationship with Olympus.


GE’s Virtual Training
GE HTMs may be taking fewer training trips to Wisconsin. GE Healthcare rolled out a new Virtual Reality training system for MRI and CT Healthcare Technology Management (HTM) professionals, intended to help its healthcare provider clients train HTMs at their own facilities. The interactive and customizable Virtual Reality training system includes “mixed reality” training using wearable devices and web-enabled technology for guided instruction on service and repairs. GE emphasized the looming need for training efficiency in the HTM field, as 25% of all current HTMs will reach retirement in the next 10 years, requiring the training of a large new generation of workers. The idea of virtual reality training is emerging across industries, and is actually not new within GE, as the company already has VR-based training at its healthcare headquarters and has offered VR-based training for end-users in other industries, including nuclear engineers.

The Wire

  • Dutch image analysis developer ScreenPoint Medical completed a $5 million Series B funding round, led by its new minority stakeholder Siemens Healthineers, for the development of its Transpara mammography evaluation software, while separately announcing an agreement with Siemens to jointly develop breast imaging AI solutions.
  • Hitachi Japan launched the LISENDO 880LE cardiovascular ultrasound, adding a new 3D transthoracic matrix probe for 3D heart images and new cardiac ejection fraction measurement capabilities, replacing the LISENDO 880 in Japan and potentially expanding to the US and Europe later this year.
  • A Signify Research post suggests that despite the global digital radiography market’s 5% growth in 2017 and similar growth forecast for 2018, the demand driven by analog/CR-to-DR conversions is waning in developed markets, leading to declining growth and falling prices in industrialized countries while emerging markets continue to drive stronger DR growth.
  • Intelerad introduced its InteleOne Maestro enterprise workflow orchestration solution, which allows integration of disparate systems across an enterprise, supporting order and image management, automating workflows, and speeding diagnostic performance.
  • Preclinical imaging manufacturer MR Solutions unveiled a new ‘gapless’ continuous PET detection system, which replaces large traditional photomultiplier tubes (PMTs) with its homegrown silicon-based photomultipliers (SiPM) detector head and LYSO pixilated detector, thus eliminating gaps between rings and allowing continuous scanning.
  • Less than a month after signing large US dealer Brown’s Medical Imaging, Glassbeam announced a distribution partnership with the major Latin America ISO, Calamed, allowing Calamed to offer its clients Glassbeam’s advanced maintenance analytics and remote monitoring solutions for MRIs and CTs.
  • Sectra announced positive earnings for its 2017/2018 fiscal year, with orders up an impressive 26.7% to SEK 1.492 billion ($168M), sales up 11% to SEK 1.266 billion ($142M), and operating profit up 19.5% to SEK 239 million ($27M), while its Imaging IT segment revenue grew 6.4% to SEK 1.03 billion ($116M).
  • It was a big week for medical imaging AI on NPR. All Things Considered also detailed a Johns Hopkins team’s work to develop an AI algorithm for the early detection of pancreatic cancer, combining radiologists and software developers to create a CT-based solution that can identify the pancreas (not easy) and then spot any tumors on it.
  • Richardson Healthcare joined the exclusive group of CT tube manufacturers, launching the ALTA750 replacement CT tube for Toshiba/Canon Medical Systems’ CXB-750D/4A tube (compatible with Aquilion CTs and 1st gen. PRIME CTs), which achieves OEM compatibility by loading a new CT vacuum tube into an OEM housing assembly.
  • Medical imaging AI developer EnvoyAI announced its first-ever installation, signing Raleigh-area 50-radiologist practice, Wake Radiology, which will use the platform to access EnvoyAI’s marketplace of over 53 AI engines and apply them to its medical imaging studies.


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