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📡 2026-07-13 — Where Medtech's Energy Is Going

Market-wide analysis: hot categories, cooling categories, new-entrant clusters, incumbent defensive moves, and distress signals. Independent of any specific product set.
Weekly All Medtech Momentum: last 365d vs 1825d baseline Incumbent moves: last 90d New entrants: last 365d
Free edition · Published by Elephant Hawk — elephanthawk.com/tools
Hottest category (1y/5y ratio)
4.23×
— see below
Codes attracting new entrants
15
top: 37 first-timers in QIH
Top-50 incumbent moves
72
59 reinforce · 13 expand · 32 active firms
Distress signals
0
acquisition candidates

🔥 Hot Categories — FDA Codes Accelerating

Top FDA product codes by velocity ratio (last 365d clearance rate ÷ last 1825d baseline rate). A ratio of 2.0× means the code is filing at twice its long-run pace right now. These are the codes the industry's R&D and capital are concentrating in.

RankCodeDeviceSpecialtyClass VelocityRecent (1y)Baseline (5y)Recent sponsors
1 4.23× 11 13 11
2 KRH Ring, Annuloplasty Cardiovascular II 3.33× 6 9 4
3 QSM System, Surgical, Computer Controlled Instrument, Remanufactured Gastroenterology, Urology II 3.13× 5 8 2
4 QYE Reduced Ejection Fraction Machine Learning-Based Notification Software Cardiovascular II 3.0× 3 5 3
5 PZM Next Generation Sequencing Based Tumor Profiling Test Pathology II 3.0× 3 5 3
6 LOL Hepatitis A Test (Antibody And Igm Antibody) Microbiology II 3.0× 3 5 2
7 LYC Bone Grafting Material, Synthetic Dental II 2.86× 4 7 3
8 SCA Multi-Analyte Respiratory Virus Antigen Detection Test Microbiology II 2.73× 6 11 5
9 DXT Injector And Syringe, Angiographic Cardiovascular II 2.69× 7 13 6
10 MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular II 2.5× 9 18 6
11 GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery II 2.5× 6 12 4
12 GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology II 2.5× 6 12 6
13 OLI Fat Reducing Low Level Laser General, Plastic Surgery II 2.5× 5 10 4
14 DHB System, Test, Radioallergosorbent (Rast) Immunological Immunology II 2.5× 4 8 1
15 MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology II 2.5× 3 6 3

🚀 New-Entrant Clusters — Codes Attracting First-Time Filers

FDA product codes ranked by the number of sponsors who filed their FIRST 510(k) in that code during the last 365 days. High first-timer counts = new capital + new R&D entering the category. This is the leading edge of where the focus is going (lags the underlying R&D investment by ~12-24 months).

RankCodeDeviceSpecialty First-time filersSample firms
1 QIH Automated Radiological Image Processing Software Radiology 37 Ai4medimaging Medical Solutions S.A.Airs Medical, Inc.Angiowave Imaging, Inc.Anumana, Inc.Avatar Medical
2 LLZ System, Image Processing, Radiological Radiology 33 AS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc.Artiness S.R.L
3 GEX Powered Laser Surgical Instrument General, Plastic Surgery 29 Baoding Te'Anzhou Electronic Technology Co., Ltd.Beijing HuaCheng Taike Technology Co., Ltd.Beijing Superlaser Technology Co., Ltd.Bellamia Technologies, Inc.Boston Aesthetics, Inc.
4 OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery 21 Atop Lighting Co., Ltd.Dongguan Yanxi Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd.Heat IN A Click, LLC
5 ITI Wheelchair, Powered Physical Medicine 20 Beijing OrionStar Technology Co., Ltd.Hebei Dansong Medical Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jiangsu Yveelt Medical Equipment Co., Ltd.Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
6 GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 19 Acotec Scientific Co., Ltd.Ascblue CorporationAsterasys Co., Ltd.Atraverse Medical, Inc.Aventix Medical, Inc.
7 GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology 18 Ab Medica SasFloShield, Inc.Freyja Healthcare, LLCHangzhou Hawk Optical Electronic Instruments Co., Ltd.Hangzhou Viction Medical Technology Co.,Ltd
8 LRK Device, Anti-Snoring Dental 14 Aiomega, LLCAirway Technologies D/B/A Airway ManagementDcstar, Inc.Dongguan Yiyao Science & Technology Development Co., Ltd.Endeavor Commerce, LLC
9 DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular 13 80 Beats Medical GmbHBeijing Hanvon Health Technology Co., Ltd.Biozen, LLCCardio Ring Technologies, Inc. Taiwan BranchCemho Medical Technology (Guangdong) Co., Ltd.
10 ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic 13 Degen MedicalEffortmed, LLCHC Biologics, LLCIntelivation TechnologiesL&K BIOMED Co., Ltd.
11 INI Vehicle, Motorized 3-Wheeled Physical Medicine 13 Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Bangbang Intelligent Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.
12 FRO Dressing, Wound, Drug Unknown 12 Beijing Kreate Medical Co., Ltd.Huizhou Foryou Medical Co., Ltd.Infection Elimination Solutions, LLCInnovaCorium, Inc.Letus Corporation
13 NKB Thoracolumbosacral Pedicle Screw System Orthopedic 12 Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCChanpin Medtak Co., Ltd.Double Medical Technology, Inc.
14 DYB Introducer, Catheter Cardiovascular 12 Cardiocycle Medical(Suzhou) Co., Ltd.Cultiv8 1, LLCEcho Medical, LLCHealth Line International CorporationInquis Medical
15 OLO Orthopedic Stereotaxic Instrument Neurology 11 Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC

🛡️ What the Top 50 US Medtech Incumbents Are Doing

Recent filings by the top-50 sponsors (by lifetime US 510(k) volume) in the last 90 days. REINFORCE = filed in a code they already own (label expansion, supplement, follow-on = moat-protection move). EXPAND = filed in a code where they had NO prior presence (strategic territory move). Ratio of reinforce vs. expand tells you whether the incumbents are playing defense or going on offense.

Defensive balance: 59 reinforce moves vs 13 expand moves · 82% reinforce · 18% expand · 32 of 50 incumbents active in window
DateFirmMoveCode ClassSpecialtyDevice
2026-06-26 Arthrex, Inc. reinforce MBI II Orthopedic Arthrex FiberButton
2026-06-26 Edwards Lifesciences expand PZX II General, Plastic Surgery ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Lef
2026-06-25 Siemens Medical Solutions USA, Inc. reinforce QIH II Radiology syngo.CT Coronary Cockpit
2026-06-25 Arthrex, Inc. reinforce HWC II Orthopedic Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
2026-06-25 Alphatec Spine, Inc. expand SIN II Orthopedic IntraOp Alignment System; CONTOUR3D Bending System
2026-06-24 STERIS Corporation reinforce FLE II General Hospital AMSCO 700 Steam Sterilizer
2026-06-24 Medtronic, Inc. reinforce KRD II Cardiovascular Concerto Versa™ Detachable Coil
2026-06-24 Ge Medical Systems, LLC reinforce JAK II Radiology Enhanced Boundary for PCCT
2026-06-22 Medline Industries, LP expand DXQ II Cardiovascular Medline Reusable Blood Pressure Cuff
2026-06-18 Siemens Medical Solutions USA, Inc. reinforce MUE II Radiology MAMMOMAT B.brilliant (11372950)
2026-06-17 Boston Scientific Corporation reinforce ODG II Gastroenterology, Urology RIVOS™ EUS Access Device (M00553900)
2026-06-17 Abbott Medical reinforce DQY II Cardiovascular Amplatzer TorqVue Exchange System
2026-06-17 Hologic, Inc. expand GEI II General, Plastic Surgery CoolSeal Generator® (CSL-200-90)
2026-06-16 Siemens Medical Solutions USA, Inc. reinforce IYN II Radiology ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diag
2026-06-16 Zimmer, Inc. reinforce LZO II Orthopedic Z1 Hip System
2026-06-16 Zimmer, Inc. reinforce PHX II Orthopedic Augment Off-Axis Instrument System
2026-06-12 Roche Diagnostics reinforce PZI II Clinical Chemistry cobas pulse blood glucose monitoring system
2026-06-11 Edwards Lifesciences, LLC expand BZQ II Anesthesiology Respiration Rate algorithm
2026-06-11 SurGenTec, LLC reinforce MRW Unknown Ion-L
2026-06-10 Penumbra, Inc. reinforce NRY II Cardiovascular Penumbra System (Thunderbolt Aspiration Tubing)
2026-06-05 Edwards Lifesciences expand DXC II Cardiovascular Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
2026-06-05 Medtronic Sofamor Danek USA, Inc. reinforce GEI II General, Plastic Surgery OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
2026-06-04 Varian Medical Systems, Inc. reinforce JAK II Radiology Respiratory Gating for Scanners (2.1)
2026-06-04 Covidien, LLC expand SFE II Gastroenterology, Urology Instrument Exit Point on Touch Surgery™ Aide
2026-06-04 Masimo Corporation reinforce MHX II Cardiovascular Radius VSM and Accessories

❄️ Cooling Categories — FDA Codes Decelerating

FDA product codes where clearance velocity is FAR below long-run baseline. Two interpretations: (a) the category is dying / commoditized → vacated white space someone could re-enter cheaply, OR (b) the use case is being replaced by a different technology (e.g., glucose meters declining as CGM eats their share). Either way, useful intelligence.

RankCodeDeviceSpecialty VelocityRecent (1y)Baseline (5y)
1 KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology 0.0× 0 27
2 LYY Latex Patient Examination Glove General Hospital 0.0× 0 25
3 FYC Gown, Isolation, Surgical General, Plastic Surgery 0.0× 0 20
4 JDR Staple, Fixation, Bone Orthopedic 0.0× 0 21
5 FLL Continuous Measurement Thermometer General Hospital 0.13× 2 80
6 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 0.16× 1 32
7 FXX Mask, Surgical General, Plastic Surgery 0.19× 9 235
8 LZA Polymer Patient Examination Glove General Hospital 0.19× 14 369
9 QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery 0.21× 1 24
10 MCW Catheter, Peripheral, Atherectomy Cardiovascular 0.23× 1 22
11 LFL Instrument, Ultrasonic Surgical Unknown 0.23× 1 22
12 MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology 0.29× 4 68
13 JOJ Indicator, Physical/Chemical Sterilization Process General Hospital 0.3× 2 33
14 KGO Surgeon'S Gloves General, Plastic Surgery 0.32× 2 31
15 QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology 0.34× 2 29

⚠️ New Distress Signals (Market-Wide)

Firms across all US medtech that recently tripped the distress signal: small US-cleared portfolio (≤8 clearances), Class I recall in window, dormant ≥730 days. Potential M&A targets via Hilco / Ocean Tomo / Heritage Global outreach.

No new distress signals in window. The standing watch order with Hilco / Ocean Tomo continues to monitor.

🔭 All Medtech Lane Spotlight

Filtered view of the same window, restricted to None FDA codes in the All Medtech code list. Shown because you ran the brief with --lane all. The market-analysis sections above are still the primary view; this is supplementary.

No events in All Medtech lane during the window.

📰 Coming Next — External Signal Sources

v0.5 of the Market Pulse uses Chrysalis Intelligence warehouse data only — which is a LAGGING indicator of market direction (clearances reflect ~12-18 months of prior R&D + regulatory work). The LEADING-edge signals come from external sources below. Each layers cleanly on this brief.

v1 · Press Releases
PR Newswire, Business Wire, GlobeNewswire — fundraising announcements, product launches, partnerships, M&A. This is where you'll see "Firm X raises $50M Series B to develop Y" BEFORE the FDA filing. Highest-value next add.
v2 · Clinical Trials (ClinicalTrials.gov)
New trial starts and registry updates — 12-24 months ahead of any clearance. Strong leading indicator for where R&D money is being spent.
v3 · Trade Show Calendar + Target Attendee List
MD&M, RSNA, AAOS, AAOMS, ADA, ASCO, HIMSS, CES Health. Next-30-days view with firms exhibiting + what they're launching. Real-time signal of "where the booth budget is going."
v4 · Industry Trade Press + SEC EDGAR M&A
MedTech Dive, MassDevice, MedCity News, MD+DI editorial + SEC 8-K M&A filings. Concurrent + retrospective context.
v5 · AI Synthesis Layer
Claude weekly "story of the week" prose — what changed, why it matters, what to do this week. Layered on all of the above.