📡 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 Robotics Future 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

top: 37 first-timers in QIH

Top-50 incumbent moves

59 reinforce · 13 expand · 32 active firms

Distress signals

acquisition candidates

Section 1 · Where the Energy IS

🔥 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.

Rank	Code	Device	Specialty	Class	Velocity	Recent (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

Section 2 · Where the New Energy is Coming From

🚀 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).

Rank	Code	Device	Specialty	First-time filers	Sample 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

Section 3 · How Incumbents Are Defending

🛡️ 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

Date	Firm	Move	Code	Class	Specialty	Device
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

Section 4 · Where the Market is Pulling Back

❄️ 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.

Rank	Code	Device	Specialty	Velocity	Recent (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

Section 5 · Acquisition Windows

⚠️ 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.

Optional Spotlight

🔭 Robotics Future Lane Spotlight

Filtered view of the same window, restricted to 26 FDA codes in the Robotics Future code list. Shown because you ran the brief with --lane robotics. The market-analysis sections above are still the primary view; this is supplementary.

No events in Robotics Future lane during the window.

v1+ Roadmap

📰 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.