MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – June 13, 2025
One Big Thing Regulators, providers and investors just treated AI‑imaging as “business‑critical infrastructure.” FDA’s CADx‑to‑Class II order, Viz.ai’s third neuro‑module clearance and a bipartisan push to pay for AI all landed in the same week—compressing regulatory, clinical and economic tail‑winds into a single market‑moving burst. Key Takeaways Signal‑to‑Noise Heat Bar Where last week’s 10 macro signals rank Signal Pulse Heatmap Six events that actually […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – May 30, 2025
One Big Thing The FDA’s decision to roll its in-house generative-AI suite across all centers by 30 June collides with Hyperfine’s tenth-gen Optive AI clearance: regulatory throughput and bedside image quality are now improving in lock-step, compressing go-to-market timelines and expanding clinical reach simultaneously. Key Takeaways Signal Pulse Heatmap Event Score Marketstrat Takeaway FDA AI […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – May 23, 2025
One Big Thing AI-first imaging is sprinting ahead—just as tariff headwinds force OEMs to redraw global supply chains. This week’s triple-play of U.S. AI clearances (fetal heart ultrasound, spine MRI, and interventional CBCT) landed within 72 hours, underscoring the FDA’s momentum on imaging AI. Meanwhile, new tariff disclosures exceed US $2 B for the top […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – May 16, 2025
AI breaks out of the lab—and into clinical ops, policy, and even the iPhone. May 16, 2025. One Big Thing In one seven-day span we saw: Why it matters: Clinical, regulatory, and consumer frontiers converged this week—underscoring that competitive advantage now hinges on execution speed in AI adoption and ecosystem partnerships rather than on algorithms […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – May 9, 2025
AI imaging graduates from “single feature” to enterprise platform – May 9, 2025 One Big Thing FDA stands up a Chief AI Officer and mandates generative-AI adoption across every center by 30 June 2025. Marketstrat modeling shows a 10-15 % uplift in 2025 AI-device clearances, pulling an estimated $430 M of imaging-AI revenue one quarter […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – May 2, 2025
Payment momentum meets oncology-AI arms race ONE BIG THING Medicare moves from rhetoric to rules on imaging-AI payment Draft legislative language circulating in both the House and Senate directs CMS to publish a transitional payment framework for FDA-cleared imaging algorithms within 12 months. The aim is to define a temporary coding and reimbursement structure so […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – APRIL 25, 2025
April 25, 2025 A. Executive Narrative – “From Hype to Hard Edges” Last week felt like a turning point. Two long-standing bottlenecks—payment and adaptive-AI regulation—finally got real solutions. Washington introduced a bipartisan bill (S. 1399) to place FDA-cleared AI algorithms into a 5-year Medicare “New-Tech” payment lane, while AdvaMed’s 19-page AI Policy Roadmap urged Congress […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF
April 18, 2025 The “One Big Thing” Regulators green‑lighted a record seven imaging or therapeutic AI devices in one week while Congress introduced the bipartisan Health Tech Investment Act to guarantee Medicare payment for FDA‑cleared AI tools. Translation: the two biggest barriers to clinical AI adoption—regulatory uncertainty and reimbursement—are falling in rapid succession. Market‑ready vendors now face a […]
RadNet Acquires iCAD: A Synergistic Leap in AI-Powered Breast Imaging
April 16, 2025 Introduction & Context On April 15, 2025, RadNet, Inc. announced plans to acquire iCAD, Inc. in an all-stock transaction—folding iCAD’s breast imaging AI solutions into RadNet’s DeepHealth digital health division. The day after, RadNet leadership and iCAD executives held a call to expand on the deal’s rationale, synergy opportunities, and how it […]
MARKINTEL PULSE: WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – April 11, 2025
April 11, 2025 Welcome to this week’s Markintel Pulse, your inside track on MedTech, imaging, and digital health. We’re leading with news on a pivotal trial for a fully disposable robotic catheter that could reshape endovascular procedures. Also inside: new integrated PACS enhancements, extended-wear CGMs, and a fresh wave of funding for novel ortho and […]
