FDA posts IntelePACS recall over cybersecurity flaw; contrast mammography trial misses primary end point; CT matches IVUS for PCI guidance

• FDA Nov 4, 2026
  FDA posts class 2 recall of IntelePACS software on 560 platforms over cybersecurity flaw that could let attackers alter images
  The Food and Drug Administration (FDA) posted a class 2 recall of Intelerad Medical Systems' IntelePACS software covering 560 software platforms, after a cybersecurity vulnerability was identified that could allow a malicious user to take over an administrator session and delete or modify image or study data, or lock legitimate users out of the system. A separate issue may result in the unintended deletion of image data from an external archive integration. The company told customers they can continue to use their systems by following their organization's standard cybersecurity practices; the recall was initiated Sept. 10.
  Source: FDA
• Research Nov 3, 2026
  Preoperative contrast-enhanced mammography changes treatment in 8.4% of patients, missing PROCEM trial's 10% primary end point
  In the PROCEM randomized trial in Radiology, preoperative contrast-enhanced mammography (CEM) changed treatment in 17 of 202 participants (8.4%, 95% CI 5.3 to 13.1), and the trial did not meet its primary end point of a 10% treatment change. Mastectomy rates (17% versus 18%, P = .78) and reoperation rates (7.9% versus 10%, P = .39) did not differ between the CEM and control groups. CEM showed the closest agreement with histopathologic malignant extent (bias, 3.5 mm), versus 4.8 mm for mammography or tomosynthesis and 10.7 mm for ultrasound.
  Sources: Radiology, PubMed, Crossref, AuntMinnie
• Research Nov 6, 2026
  Screening MRI finds more early cancers than mammography at intermediate to high risk, with similar advanced cancer rates
  A retrospective Breast Cancer Surveillance Consortium study published Nov. 6 in JAMA Network Open, reported by AuntMinnie, included 172,865 exams in 105,532 women ages 40 to 74 performed between 2005 and 2021. In women at intermediate to high risk of advanced cancer, MRI detected 10.3 versus 2.8 early-stage cancers per 1,000 exams, while advanced cancer rates did not significantly differ (0.8 versus 0.6 per 1,000). False-positive biopsy recommendation rates were higher with MRI (94.0 versus 18.1 per 1,000). Dr. Karla Kerlikowske led the study.
  Source: AuntMinnie
• Payment Nov 4, 2026
  ACR outlines 1% rise for diagnostic radiology and 3% for interventional radiology in final 2027 Medicare fee schedule
  The Centers for Medicare & Medicaid Services (CMS) 2027 physician fee schedule final rule lowers the conversion factor 2.31% to $32.63 for clinicians outside qualifying alternative payment models. The American College of Radiology (ACR) said policy changes in the rule that "appear to be positive" for radiology bring increases of 1% for diagnostic radiology, 3% for interventional radiology and 1% for nuclear medicine, though actual impacts may be less because of the conversion factor decrease, according to AuntMinnie. CMS also sought information on duplicate testing, saying diagnostic imaging and laboratory results are frequently siloed within acquiring electronic health record systems.
  Sources: CMS, AuntMinnie
• Research Nov 1, 2026
  CT angiography guidance is noninferior to IVUS for PCI in P4 trial, with 4.1% versus 4.6% one-year target vessel failure
  The New England Journal of Medicine published the randomized P4 trial, presented Nov. 1 at TCT 2026, comparing coronary CT angiography (CCTA) with intravascular ultrasound (IVUS) for guiding percutaneous coronary intervention (PCI) in 556 and 549 patients. Target vessel failure at one year, a composite of cardiac death, target vessel myocardial infarction or ischemia-driven revascularization, was 4.1% with CCTA guidance and 4.6% with IVUS guidance, meeting noninferiority (P < .001), according to TCTMD. Median PCI duration was 46 minutes versus 63 minutes, Diagnostic Imaging reported on the study led by Dr. Carlos Collet of the Cardiovascular Research Foundation.
  Sources: NEJM, Diagnostic Imaging, TCTMD, Crossref
• Research Nov 3, 2026
  Daratumumab immuno-PET finds myeloma missed by FDG PET/CT in 13% of 60 participants in phase 2 trial
  In a phase 2 trial published in Radiology, CD38-targeted zirconium 89 deferoxamine-daratumumab PET/CT showed at least one positive lesion in 43% of participants with multiple myeloma (26 of 60; 95% CI 31 to 57), versus 47% (28 of 60) with fluorine 18 FDG PET/CT, with no overall difference (P = .81). Myeloma was detected only with the daratumumab tracer in 13% (eight of 60) of participants.
  Sources: Radiology, PubMed, Crossref
• AI Nov 3, 2026
  GE HealthCare adds FDA-cleared AI lung guidance and aortic stenosis tools to Vscan Air handheld ultrasound
  GE HealthCare said Nov. 3 that Lung Guidance and AutoAS, both with Food and Drug Administration (FDA) 510(k) clearance, are coming to its Vscan Air SL handheld ultrasound. Lung Guidance gives real-time guidance across the standard eight-zone lung protocol; in a descriptive assessment of internal data, nonexpert users acquired diagnostic-quality exams 95.2% of the time versus 96.8% for experts, the company said. AutoAS indicates whether two or more two-dimensional echocardiographic views suggest moderate-to-severe aortic stenosis, with a confidence score; no performance figures were given. Subscribers should get the updates by the end of November, GE HealthCare said.
  Sources: GE HealthCare, AuntMinnie

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