Top 10 FDA Submissions 2026
510(k) clearances, PMA approvals, CE marks, and IDE studies shaping the 2026 medical device market — 47 active submissions tracked
| # | Company / Device | Category | Pathway | Status | Indication | Est. Decision | Signal |
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| 01 | Diabetes | 510(k) | ✓ Cleared Apr 25, 2026 | Continuous glucose monitoring | Cleared | 15-day real-time CGM, no calibration required NASDAQ: DXCM ↗ loading... |
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| 02 | Imaging | 510(k) | ✓ Cleared Mar 2026 | Point-of-care ultrasound | Cleared | AI-guided whole-body POC ultrasound NYSE: BFLY ↗ loading... |
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| 03 | Spine | 510(k) | ✓ Cleared Feb 2026 | Spinal surgery navigation | Cleared | Machine-vision, radiation-free navigation Private |
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| 04 | Surgical Robotics | 510(k) | ⏳ Under Review | Robotic-assisted soft tissue surgery | Q2 2026 | US soft tissue robotic surgery clearance NYSE: MDT ↗ loading... |
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| 05 |
SS
OMNI 2.0
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Ophthalmology | 510(k) | ⏳ Under Review | Canal MIGS glaucoma procedure | Q2 2026 | Canal-based MIGS expanded indications Private |
| 06 | Neuromodulation | PMA Supplement | ⏳ Under Review | Pediatric OSA expanded indication | Q3 2026 | HNS therapy — pediatric OSA label expansion NYSE: INSP ↗ loading... |
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| 07 | Neuromodulation | PMA Supplement | ⏳ Under Review | Chronic back & leg pain | Q3 2026 | New stimulation waveforms for SCS Private |
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| 08 | Surgical Robotics | CE Mark | ✓ CE Mark Q1 2026 | Collaborative laparoscopic robot | Cleared EU | Collaborative lap robot — EU launch ready Private |
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| 09 | Diabetes | PMA Supplement | ⏳ Under Review | Dual-hormone closed-loop insulin system | Q4 2026 | Bihormonal APS — glucagon + insulin Private |
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| 10 | Diagnostics | De Novo | ⚡ Breakthrough Device | Swallowable robotic GI capsule | 2027 | Remote-controlled robotic capsule endoscopy Private |
✅ Recent Clearances
3 devices cleared in 2026World's first FDA-cleared 15-day wear CGM with no fingerstick calibration required. Replaces the G7 in Dexcom's core lineup with 20% improved accuracy at hypoglycemic range. Estimated 4M+ US users eligible for upgrade.
Extends Dexcom's CGM leadership, strengthens competitive moat vs. Abbott Libre 3+. GLP-1 + CGM convergence expands total addressable market.
Third-generation single-probe whole-body ultrasound with integrated AI guidance for 50+ clinical protocols. 40% thinner than iQ2, USB-C charging, battery life extended to 3 hours continuous scanning.
Hospital-at-home trends driving demand for portable diagnostics. iQ3 positions Butterfly for ED, ICU, and rural health center deployments globally.
Machine-vision surgical navigation system eliminating intraoperative radiation for spine surgeons and OR staff. Flash registration in under 30 seconds using standard OR lighting — no fiducials, no extra CT scans.
Radiation-free navigation becoming a key differentiator for hospital purchasing. Positions 7D as disruptive alternative to legacy C-arm-dependent navigation systems.