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MedTech Innovation Coalition

Medical DevicesCompanion DiagnosticsDigital Health
18 provisions tracked
5 positive
6 negative
IndirectSec. CMS-2027-01 · CMS Medicare Drug Price Negotiation — 2027 Expansion

Nexavar-X (Sorafenib Extended-Release) — Oncology Biologic

Companion diagnostic for Nexavar-X (OncoDx Panel) may see reduced demand if therapy adoption declines post-negotiation.

$2.1B annual revenue (47% of Apex total)
IndirectSec. CMS-2027-02 · CMS Medicare Drug Price Negotiation — 2027 Expansion

Immunara / Immunara-SC — Autoimmune Biologics

Autoimmune diagnostic panels linked to Immunara prescribing — reduced therapy use impacts companion dx revenue.

$1.8B combined annual revenue
IndirectSec. FDA-2026-AR · FDA Regulatory Reform

FDA Accelerated Approval Reform — Post-Market Evidence Requirements

New patient registry framework for RWE collection creates opportunities for MedTech diagnostic and monitoring platforms.

Est. $45-80M additional cost per drug
PositiveSec. CMS-2027-04 · CMS Medicare Drug Price Negotiation — 2027 Expansion

NeuroCalm XR — CNS / Psychiatric Medication

Digital therapeutic companion for NeuroCalm may see increased adoption as CMS seeks value-based alternatives.

$890M annual revenue
PositiveSec. IRA-ESOP · Legislative — Tax/Employment

Retirement Security Enhancement Act — ESOP Expansion Impact on Health Sector

MedTech startups eligible for ESOP tax credits — helps with talent retention in competitive hiring market.

$50M small business ESOP formation fund