📡 2026-08-03 — 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 Market-Wide 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)

3.75×

— — see below

Codes attracting new entrants

top: 39 first-timers in QIH

Top-50 incumbent moves

53 reinforce · 16 expand · 34 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	—	—	—	—	3.75×	9	12	9
2	LYC	Bone Grafting Material, Synthetic	Dental	II	3.13×	5	8	4
3	QSM	System, Surgical, Computer Controlled Instrument, Remanufactured	Gastroenterology, Urology	II	3.13×	5	8	2
4	LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	II	3.0×	3	5	2
5	SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	II	2.92×	7	12	5
6	KRH	Ring, Annuloplasty	Cardiovascular	II	2.78×	5	9	3
7	GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	II	2.73×	6	11	4
8	DXT	Injector And Syringe, Angiographic	Cardiovascular	II	2.69×	7	13	6
9	GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	II	2.5×	6	12	6
10	OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	II	2.5×	5	10	4
11	DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	II	2.5×	4	8	1
12	SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	II	2.5×	4	8	4
13	MVL	Cord, Retraction	Unknown	—	2.5×	3	6	3
14	MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	II	2.5×	3	6	3
15	OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	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	39	Agada Medical, Ltd.Ai4medimaging Medical Solutions S.A.Airs Medical, Inc.Angiowave Imaging, Inc.Anumana, Inc.
2	LLZ	System, Image Processing, Radiological	Radiology	34	AS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc.Artiness S.R.L
3	GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	28	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	ITI	Wheelchair, Powered	Physical Medicine	23	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
5	OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	23	Atop Lighting Co., Ltd.Dongguan Miqiang Technology Co., Ltd.Dongguan Yanxi Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd.
6	GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	20	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	INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	15	Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Bangbang Intelligent Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jochu Technology Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
9	ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	14	C.A. Medical, LLCDegen MedicalEffortmed, LLCHC Biologics, LLCIntelivation Technologies
10	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
11	DYB	Introducer, Catheter	Cardiovascular	13	Cardiocycle Medical(Suzhou) Co., Ltd.Cultiv8 1, LLCEcho Medical, LLCHartman Medical Group, LLCHealth Line International Corporation
12	NUC	Lubricant, Personal	Obstetrics/Gynecology	12	Ansella TherapeuticsGlobal Protection Corp.Golden Isles Medical, Inc.Guangzhou Haoyimai Trading Co., Ltd.Hudi Pharma Srl
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	OLO	Orthopedic Stereotaxic Instrument	Neurology	11	Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC
15	FRO	Dressing, Wound, Drug	Unknown	11	Beijing Kreate Medical Co., Ltd.Huizhou Foryou Medical Co., Ltd.Infection Elimination Solutions, LLCInnovaCorium, Inc.Letus Corporation

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: 53 reinforce moves vs 16 expand moves · 77% reinforce · 23% expand · 34 of 50 incumbents active in window

Date	Firm	Move	Code	Class	Specialty	Device
2026-07-17	Medtronic Sofamor Danek USA, Inc.	reinforce	MAX	II	Orthopedic	Catalyft PL Expandable Interbody System
2026-07-17	Stryker Endoscopy	expand	SIT	—	—	SportSuite Vision Software
2026-07-16	Roche Molecular Systems, Inc.	expand	PQA	II	Microbiology	cobas® BV/CV
2026-07-15	Abbott Medical	reinforce	DQK	II	Cardiovascular	EnSite X EP System
2026-07-14	Intuitive Surgical, Inc.	reinforce	GCJ	II	Gastroenterology, Urology	Universal Seal (5-12 mm)
2026-07-14	Alphatec Spine, Inc.	reinforce	NKB	II	Orthopedic	Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal F
2026-07-14	Medtronic Sofamor Danek USA, Inc.	reinforce	MAX	II	Orthopedic	Symmetrix L Spinal System
2026-07-10	Boston Scientific Corporation	reinforce	ESW	II	General, Plastic Surgery	WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW)
2026-07-10	Varian Medical Systems	expand	QKB	II	Radiology	AI Contouring (VA10A)
2026-07-10	Masimo Corporation	reinforce	OLW	II	Neurology	SedLine Sedation Monitor
2026-07-10	Howmedica Osteonics Corp., Dba Stryker Orthopaedics	reinforce	LPH	II	Orthopedic	Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert;
2026-07-09	Smith & Nephew, Inc.	reinforce	MBI	II	Orthopedic	Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and o
2026-07-08	Varian Medical Systems, Inc.	reinforce	MUJ	II	Radiology	Virtual Cone (1.0)
2026-07-08	bioMerieux, Inc.	expand	SAN	II	Microbiology	VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
2026-07-08	Roche Molecular Systems, Inc.	reinforce	QEP	II	Microbiology	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG f
2026-07-06	Smith & Nephew, Inc.	expand	SIQ	II	Orthopedic	TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
2026-07-01	Covidien, LLC	reinforce	GAG	II	General Hospital	Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); T
2026-07-01	SeaSpine Orthopedics Corporation	reinforce	MAX	II	Orthopedic	Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray
2026-06-29	Stryker GmbH	reinforce	HSB	II	Orthopedic	Pangea Femur Reconstruction System
2026-06-29	Philips Ultrasound, LLC	reinforce	IYN	II	Radiology	Alturion Series Diagnostic Ultrasound System
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

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	FYC	Gown, Isolation, Surgical	General, Plastic Surgery	0.0×	0	20
2	JDR	Staple, Fixation, Bone	Orthopedic	0.0×	0	21
3	LYY	Latex Patient Examination Glove	General Hospital	0.0×	0	25
4	FLL	Continuous Measurement Thermometer	General Hospital	0.13×	2	77
5	NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	0.16×	1	32
6	FRN	Pump, Infusion	General Hospital	0.17×	1	29
7	KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	0.18×	1	28
8	LZA	Polymer Patient Examination Glove	General Hospital	0.18×	13	358
9	LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	0.2×	1	25
10	FXX	Mask, Surgical	General, Plastic Surgery	0.21×	9	219
11	MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	0.22×	3	67
12	LFL	Instrument, Ultrasonic Surgical	Unknown	0.23×	1	22
13	MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	0.23×	1	22
14	JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	0.31×	2	32
15	KGO	Surgeon'S Gloves	General, Plastic Surgery	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.

Signals

📡 External Signals — This Week

Leading-edge items from live external feeds; the warehouse sections above are the lagging FDA record (clearances reflect ~12-18 months of prior R&D + regulatory work).

Press Releases leads by ~12 months

2026-08-02 — Best Ways to Dispose of Needles at Home Safely (2026): Sharps Assure Recognized by Consumer365
2026-08-01 — Best Sharps Disposal Solution for Mobile Clinics, Home Care & Home Infusion (2026): Sharps Assure Featured by Better Business Advice
2026-08-01 — Alabama-Based Simparo Inc. Earns Fourth U.S. Patent, Backed by Innovate Alabama Investment
2026-08-01 — Appointment of new CFO
2026-08-01 — Udnævnelse af ny CFO
2026-07-31 — Best Sharps Mail-Back Solutions for Small Medical Practices (2026): Sharps Assure Recognized by Expert Consumers

AI Synthesis Layer leads by weekly

2026-07-26 — AI device authorizations: what the FDA record shows
2026-07-26 — What a 510(k) clearance does not guarantee a buyer
2026-07-26 — FDA cleared vs approved vs granted vs registered
2026-07-25 — Introducing Insights

Coming next:

Clinical Trials (ClinicalTrials.gov)

New trial starts and registry updates — a strong leading indicator for where R&D money is being spent.

Trade Show Calendar + Target Attendee List

MD&M, RSNA, AAOS, AAOMS, ADA, ASCO, HIMSS, CES Health. Next-30-days view of firms exhibiting and what they're launching — real-time signal of where the booth budget is going.

Industry Trade Press + SEC EDGAR M&A

MedTech Dive, MassDevice, MedCity News, MD+DI editorial + SEC 8-K M&A filings. Concurrent and retrospective context.