#436 – The Wire

  • Kaiser Score Beats Experience: A study in European Radiology found that the “Kaiser score” (KS) breast MRI clinical decision system allows inexperienced radiology residents to achieve better diagnostic accuracy than experienced breast imaging radiologists using MR BI-RADS. Three residents using the KS system and three experienced radiologists using MR BI-RADS interpreted breast MRIs from 80 women (93 lesions, 61 malignant), with the residents achieving higher AUCs (0.842–0.928 vs. 0.723–0.742) and higher inter-reader agreement than the expert rads (kappa 0.579–0.710 vs. 0.531–0.624).
  • Caption Health’s CE Mark: Caption Health received a European CE Mark for its Caption AI platform, which uses AI guidance to allow untrained clinicians to perform cardiac ultrasound exams (vs. only sonographers), and could significantly expand access to echo exams. Caption AI gained FDA clearance in 2020 and has since generated solid US momentum, including a high-profile alliance with Butterfly Network and rare NTAP reimbursement.
  • Proposing MPFS 2023: Healthcare Administrative Partners provided a complete overview of how CMS’ proposed 2023 Medicare Physician Fee Schedule might impact radiology, headlined by reimbursement cuts (-4.4% to $33.0775 per RVU) that will bring reductions to diagnostic and interventional radiology (-3% & -4%). HAP also revealed positive news, as CMS accepted 10 new radiology-related CPT codes and announced that it would indefinitely delay the AUC/CDS program’s penalty phase. 
  • CathWorks & Medtronic’s Angio Alliance: Angiography AI company CathWorks and Medtronic expanded their partnership, leading to Medtronic investing an additional $75M in CathWorks (it was already an early investor) and the companies co-promoting CathWorks’ FFRangio System in the US, Europe, and Japan. Depending on certain milestones, Medtronic will have the option to acquire CathWorks for up to $585M. The CathWorks FFRangio System delivers multi-vessel FFR results from routine angiograms, which seems to fit well with Medtronic’s suite of angiography products.
  • Ultrasound AI Cystic Hygroma Detection: A new study out of The Ottawa Hospital showed that fetal ultrasound AI models could be used to accurately diagnose cystic hygroma during the first trimester. The researchers trained and tested the AI model using 289 fetal ultrasound images (129 cystic hygroma cases, 160 controls), finding that it identified cystic hygroma with 93% accuracy, 92% sensitivity, 94% specificity, and an AUC of 0.94.
  • Reintroducing GE HealthCare: GE Inc.’s separation into three independent companies reached a major milestone, with the unveiling of the companies’ new names and branding. GE Healthcare will be (slightly) renamed GE HealthCare, adopting updated corporate branding that combines its long-established cursive “GE” logo with new “compassion purple” coloring. GE HealthCare will be the first company to first spin-off in early 2023 (Nasdaq ticker: GEHC), followed by GE’s energy business portfolio (renamed GE Vernova) and its aviation business (renamed GE Aerospace) in 2024.
  • Handhelds Rival ABUS: A new ScienceDirect study found that handheld breast ultrasound rivals automated breast ultrasound systems (ABUS) for detecting malignant cancer in dense breasts. The two ultrasound systems were used with 592 women, finding that handhelds detected more cystic lesions (1,491 vs. 1,005) and mass lesions (336 vs. 270) than ABUS, but slightly fewer positive/suspicious cases (167 vs. 171). The two ultrasound systems achieved “good” agreement with cystic lesions, “moderate” agreement with solid mass lesions, and “good” agreement with suspicious lesions (k = 0.61-0.62 & 0.57-0.60 & 0.66).
  • Annalise.ai’s CE MDR: Annalise.ai announced the CE Mark MDR class IIb recertification of its flagship Annalise CXR Enterprise solution (detects 124 abnormalities in CXRs). Europe’s MDR certification program launched last year, requiring AI products to attain higher risk classifications (IIa, IIb, or III… no longer class I), and setting a 2024 recertification deadline for existing products. However, as of May 2022 only 17% of CE-marked AI products were MDR-recertified.
  • Contrast Reinforcements: Contrast shortage relief might be on the way, after the FDA granted Bayer rights to import a limited quantity of its foreign-labeled ULTRAVIST contrast (otherwise the same as its USA-labeled ULTRAVIST) and Fresenius Kabi launched its FDA-cleared generic Iodixanol contrast portfolio (equivalent to GE’s Visipaque). These announcements came shortly after GE Healthcare revealed that it still expects “some ongoing reduced availability” until the global supply chain restabilizes.
  • SpinTech MRI’s Series A: SpinTech MRI raised $6.5M in Series A funding that it will use to support the commercial expansion of its FDA-cleared STAGE (STrategically Acquired Gradient Echo) quantitative MRI platform. STAGE is currently deployed at more than 50 institutions, where it’s used by neurologists, radiologists, and researchers to support the MRI-based diagnosis of a range of neurological conditions.
  • Affidea & Incepto’s Portuguese Pilot: European imaging giant Affidea announced a pilot collaboration with AI platform company Incepto, beginning with four AI solutions (oncology, neurology, breast imaging) integrated at 14 imaging centers in Portugal. This is one of 10 different AI pilots that Affidea is operating across 10 different countries, although this Portuguese pilot might lead to Affidea expanding the Incepto platform further across Europe.

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-- The Imaging Wire team