Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

Consolidation may be driving radiologists away from practicing as generalists
Radiologists who experienced a practice closure are more likely to operate as subspecialists afterward, according to new Neiman research.
FDA warns Philips after issues arise at multiple manufacturing facilities
Meanwhile, the Amsterdam-based imaging giant said it has already taken action to begin correcting these issues.
FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus
The company is working to commercialize MK-6240, a radiodiagnostic that targets tau protein tangles—a “key hallmark of several neurodegenerative diseases.”
Medicare now covers renal denervation for patients with uncontrolled hypertension
This decision expands access to renal denervation to many more patients throughout the United States. Recor Medical and Medtronic both gained FDA approval for their RDN systems in 2023, and other vendors are actively developing their own treatment options.
Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead
Dan Brillman, the former CEO and co-founder of coordinated care support service Unite Us, has left his position for a role in the Centers for Medicare & Medicaid Services, where he will be responsible for overseeing the federal government's safety net healthcare programs.

New $6B Eversana looks to bypass PBMs and lower drug prices

A merger between Eversana and Waltz Health will create a new entity that CEO Mark Thierer says will upend the “existing oligopoly that I helped build.”

Dispute between Johns Hopkins and UnitedHealthcare pushes patients out-of-network

The two said they’ve been negotiating terms for eight months. Sticking points include denied claims and coverage disputes, with both the insurer and health system pointing fingers.

FDA announces recall of Boston Scientific interventional radiology devices, citing risk of serious injury or death

Its alert pertains to over 26K carotid artery stents, used by interventional neuroradiologists, vascular surgeons and other docs to prevent strokes.

AI patient portal messages personalized care

Healthcare AI today: $81M acquisition, Illinois says no to AI therapy, AI glucose cleared, more

FDA clears AI-powered glucose monitoring app. The clearance marks a first for an over-the-counter tool in this category.

Data policy research: AI hesitancy remains real, and value-based care models are still an uncertainty

Tech vendor Reveleer and policy analytics firm Mathematica released their 2025 State of Technology in Value-Based Care report, the findings of which show that AI adoption in healthcare is widespread—but integration is spotty.

warning safety alert recall healthcare issue

AI-enabled devices lacking validation data prior to FDA clearance more likely to be recalled

FDA 510(k) clearance does not require that AI devices are subject to prospective human studies prior to approval.

The Abbott Esprit BTK everolimus-eluting biosorbable scaffold system for below the knee peripheral artery disease on display at TCT 2024. Photo by Dave FornellTCTn 2024 DF

Abbott’s dissolving stent picks up a key approval

It's another big victory for Abbott's bioresorbable stent for BTK PAD.

FDA announces new recall of self-expanding stents due to risk of ‘serious harm’

The Class I recall includes more than 26,000 vascular stents from Boston Scientific. These devices have been linked to a risk of potential resistance when the stent delivery system is being withdrawn.

Policy & Regulations

Consolidation may be driving radiologists away from practicing as generalists

FDA warns Philips after issues arise at multiple manufacturing facilities

FDA accepts application for new Alzheimer’s PET imaging agent from Lantheus

Medicare now covers renal denervation for patients with uncontrolled hypertension

Former CEO of Unite Us tapped as CMS’ Medicaid and CHIP lead