FDA clears Evident Vascular's AI-powered IVUS system for peripheral interventions
A new intravascular ultrasound platform wins clearance for imaging inside peripheral vessels, though it is not yet on sale.
Evident Vascular announced on Nov. 4 that the FDA granted 510(k) clearance to its Evident Vascular Guidance System and peripheral imaging catheters, intended for ultrasound examination of intravascular pathology during peripheral vascular interventions [1]. The company describes flushless, plug-and-play catheters, hands-free voice control and an onboard AI workstation, but its release gives no performance figures and says the system is not yet available for sale [1]. Most of the AI, for now, is a promise: the firm plans to add features as clinical data build [2].
CMS finalizes 2027 physician fee schedule with lower conversion factors
Medicare's base payment rate for physician services falls roughly 2% as a one-year increase expires.
The final rule sets the 2027 conversion factor at $32.95 for clinicians in qualifying alternative payment models (down 1.83%) and $32.63 for others (down 2.31%), because a one-year 2.5% increase for 2026 lapses [3]. When an office visit is billed on the same day as a 0-day global procedure, the less expensive service will be paid at 80%, rather than the 50% CMS had proposed [3]. HHS says traditional MIPS reporting will sunset beginning with the 2031 performance period [4].
CVS Health plans to split into two public companies
After years of deals joining drugstores to an insurer, the company intends to separate them.
CVS Health said on Nov. 4 that it intends to separate into a healthcare company holding Aetna, CVS Caremark, CVS Specialty, Oak Street Health and Signify Health, and CVS Pharmacy, with about 9,000 pharmacies, mail pharmacy and MinuteClinic [5]. The separation, intended to be tax-free, is expected in the first half of 2028, subject to final board approval and other conditions [5]. STAT reported that it comes amid increased scrutiny of vertically integrated healthcare companies [6].
Medicare outpatient rule cuts 340B drug payments to ASP minus 28%
Hospitals get a 2.3% rate update alongside a multibillion-dollar change in drug payment.
The 2027 outpatient final rule, issued Nov. 4, raises payment rates 2.3% for hospitals that meet quality reporting requirements [7]. CMS will pay for 340B-acquired drugs at average sales price minus 28%, which it estimates will reduce Original Medicare drug payments by $4.35 billion and beneficiary drug payments by $1.1 billion in the first year; the policy is budget neutral, so payments for non-drug services rise by an equivalent amount [7]. CMS is also removing 637 services from the inpatient-only list [7].
Digest references
1. Evident Vascular, Inc. "Evident Vascular Receives FDA Clearance for High-Fidelity AI Powered IVUS Imaging Platform." Business Wire, Nov. 4, 2026. [businesswire.com](https://www.businesswire.com/news/home/20261104930166/en/Evident-Vascular-Receives-FDA-Clearance-for-High-Fidelity-AI-Powered-IVUS-Imaging-Platform)
2. AuntMinnie.com staff writers. "Evident Vascular secures FDA clearance for IVUS imaging system." AuntMinnie, Nov. 4, 2026. [auntminnie.com](https://www.auntminnie.com/clinical-news/ultrasound/news/16424272/evident-vascular-secures-fda-clearance-for-ivus-imaging-system)
3. Centers for Medicare & Medicaid Services. "Calendar Year (CY) 2027 Medicare Physician Fee Schedule Final Rule." CMS fact sheet, Nov. 4, 2026. [cms.gov](https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-final-rule)
4. U.S. Department of Health and Human Services. "CMS Finalizes CY 2027 Physician Fee Schedule to Shift from Sick Care to Healthcare and Curb Waste." HHS press release, Nov. 4, 2026. [hhs.gov](https://www.hhs.gov/press-room/cms-finalizes-2027-medicare-physician-fee-schedule.html)
5. CVS Health. "CVS Health announces intent to create two distinct leaders in healthcare." CVS Health news release, Nov. 4, 2026. [cvshealth.com](https://www.cvshealth.com/news/company-news/cvs-health-announces-intent-to-create-two-distinct-leaders-in-healthcare.html)
6. Herman B. "CVS Health to split, reversing years of deal-making to combine pharmacies and insurance." STAT, Nov. 4, 2026. [statnews.com](https://www.statnews.com/2026/11/04/cvs-splits-pharmacy-from-insurance/)
7. Centers for Medicare & Medicaid Services. "Calendar Year 2027 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Final Rule (CMS-1850-F)." CMS fact sheet, Nov. 4, 2026. [cms.gov](https://www.cms.gov/newsroom/fact-sheets/calendar-year-2027-hospital-outpatient-prospective-payment-system-opps-ambulatory-surgical-center-0)
