MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – Aug 22, 2025
One Big Thing Enterprise‑scale imaging AI moved from pilots to operations—Sutter’s systemwide rollout, Akumin’s 150+‑site DBT AI, and Ontario’s cloud consolidation signal that health systems are standardizing on AI‑enabled imaging stacks. Key Takeaways Quick‑Glance Table Date Headline Our Take Aug 16–22 Sutter begins systemwide AI imaging rollout (GEHC alliance) Playbook shift: fleet refresh + AI […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – Aug 15, 2025
One Big Thing Clinical AI crossed from pilot to infrastructure this week—fresh FDA actions in imaging, hospital‑grade productivity data, and Oracle’s AI‑first EHR collectively signal the next phase of real deployment. Key Takeaways Quick‑Glance Table Date Headline Our Take Aug 14 FDA approves SetPoint RA neurostimulator First FDA‑approved bioelectronic RA therapy; signals new front for neuroimmune […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – Aug 8, 2025
One Big Thing Remote imaging operations just crossed a regulatory threshold. The FDA cleared RadNet/DeepHealth’s TechLive platform for remote operation/supervision of MR, CT, PET/CT, and ultrasound—validating command‑center scanning as a category, not a feature. In the same week, public markets reopened for regulated imaging software (HeartFlow’s $316.7M IPO), and policy moved in ways that will […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – July 18-Aug 1, 2025
One Big Thing Provider‑funded foundation models burst onto the scene. Four U.S. hospital groups co‑led Aidoc’s $150 M raise to build a multimodal “clinical reasoning engine,” signalling that future AI winners will be hard‑wired into provider capex cycles. Key Takeaways Quick‑Glance Date Headline Why it matters Jul 31 SetPoint vagus‑stim PMA Opens neuro‑immune device class for RA; payers […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – July 11, 2025
One Big Thing AI’s center‑stage moment: clinical evidence, billion‑dollar funding rounds and the EU AI Act all converged this week—turning regulatory prowess into the new competitive moat for imaging‑AI vendors. Key Takeaways Quick-Glance Table Date Headline Our Take 9 Jul Ultromics AI flags cardiac amyloidosis, AUC 0.93 Screening/flagging category will scale fastest—low‑risk, huge value 10 Jul Samsung buys Xealth Wearables + Rx‑apps […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – July 4, 2025
One Big Thing AI‑accelerated MRI goes mainstream. Philips won FDA 510(k) clearance for SmartSpeed Precise, a dual‑AI reconstruction engine that delivers 3× faster scans and up to 80 % sharper images in a single click—and it’s field‑upgradable to the entire Philips 1.5 T / 3 T fleet. Why it matters: Imaging departments plagued by staff shortages and backlogs can unlock one extra patient‑day per […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – June 27, 2025
One Big Thing FDA green‑lights Siemens’ virtually helium‑free 1.5 T MRI (Magnetom Flow.Ace)—a scanner that needs <1 L of helium, eliminates quench pipes, and bakes‑in AI reconstruction to cut exam times by >30%. It directly attacks two industry pain points: helium price volatility and radiology throughput. Key Takeaways Signal-to-Noise Bar Signal Pulse Heatmap Quick Glance Grid ¹Signal scale = 1‑5; see Visual 1 for […]
MARKINTEL PULSE – WEEKLY MEDTECH, IMAGING & DIGITAL HEALTH BRIEF – June 20, 2025
One Big Thing Regulation just removed the moat around radiology AI. On 13 June the FDA re‑classified radiological CADe/CADx from Class III (PMA) to Class II (510(k)). That turns a US $3‑5 M, 30‑month slog into a sub‑$500 k, 90‑day filing. Our model (see Visual 3) shows ≥1,000 additional filings through 2026, compressing prices for “me‑too” algos and transferring value to orchestration platforms and data owners. […]
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 […]
