📡 2026-06-29 — 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)

3.89×

— see below

Codes attracting new entrants

top: 38 first-timers in QIH

Top-50 incumbent moves

53 reinforce · 13 expand · 31 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		—	—	—	3.89×	7	9	7
2	KRH	Ring, Annuloplasty	Cardiovascular	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	QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software	Cardiovascular	II	3.0×	3	5	3
6	PZM	Next Generation Sequencing Based Tumor Profiling Test	Pathology	II	3.0×	3	5	3
7	LYC	Bone Grafting Material, Synthetic	Dental	II	2.86×	4	7	3
8	OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	II	2.78×	5	9	4
9	SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	II	2.73×	6	11	5
10	DXT	Injector And Syringe, Angiographic	Cardiovascular	II	2.69×	7	13	6
11	MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	II	2.5×	9	18	6
12	OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	II	2.5×	5	10	4
13	DSB	Plethysmograph, Impedance	Cardiovascular	II	2.5×	3	6	3
14	MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	II	2.5×	3	6	3
15	MVL	Cord, Retraction	Unknown	—	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	38	Ai4medimaging Medical Solutions S.A.Airs Medical, Inc.Angiowave Imaging, Inc.Avatar MedicalBeauBrain Healthcare, Inc.
2	LLZ	System, Image Processing, Radiological	Radiology	31	AS Software, LLCAgfa Healthcare N.V.Archy Dental, Inc.Artiness S.R.LAugmented Reality Software S.L.
3	GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	31	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 SasBoehringer Laboratories, LLCFreyja Healthcare, LLCHangzhou Hawk Optical Electronic Instruments Co., Ltd.Hangzhou Viction Medical Technology Co.,Ltd
8	ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	13	Degen MedicalEffortmed, LLCHC Biologics, LLCIntelivation TechnologiesL&K BIOMED Co., Ltd.
9	INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	12	Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Bangbang Intelligent Technology Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.Nanjing Mijo Technology Co., Ltd.
10	DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	12	Aktiia SABeijing Hanvon Health Technology Co., Ltd.Biozen, LLCCardio Ring Technologies, Inc. Taiwan BranchCemho Medical Technology (Guangdong) Co., Ltd.
11	LRK	Device, Anti-Snoring	Dental	12	Aiomega, LLCAirway Technologies D/B/A Airway ManagementDcstar, Inc.Dongguan Yiyao Science & Technology Development Co., Ltd.Koncept Innovators, Inc.
12	FRO	Dressing, Wound, Drug	Unknown	11	Beijing Kreate Medical Co., Ltd.Huizhou Foryou Medical Co., Ltd.Infection Elimination Solutions, LLCInnovaCorium, Inc.Letus Corporation
13	NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Neurology	11	A-1 EngineeringAura Medical, LLCEl Global Trade, Ltd.Guangxi Ulike Medical Technology Co., Ltd.ShenB Co., Ltd.
14	OLO	Orthopedic Stereotaxic Instrument	Neurology	11	Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC
15	NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	10	Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCDouble Medical Technology, Inc.Globus Medical, Inc.

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 13 expand moves · 80% reinforce · 20% expand · 31 of 50 incumbents active in window

Date	Firm	Move	Code	Class	Specialty	Device
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
2026-06-04	Stryker Endoscopy	expand	GWG	II	Neurology	Precision S 4K Sinuscope
2026-06-02	Life Spine, Inc.	reinforce	OLO	II	Neurology	SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
2026-05-28	Arthrex, Inc.	reinforce	MAI	II	Orthopedic	Arthrex Bioabsorbable PushLock Suture Anchors
2026-05-28	Medtronic	expand	GAM	II	General, Plastic Surgery	Trexon Monofilament Synthetic Absorbable Suture
2026-05-28	Zimmer, Inc.	reinforce	MBH	II	Orthopedic	Zimmer® Persona® Personalized Knee System
2026-05-28	Stryker Endoscopy	expand	IZI	II	Radiology	780 nm SPY Portable Handheld Imaging (SPY-PHI) System
2026-05-27	Philips Ultrasound, LLC	reinforce	IYN	II	Radiology	EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic
2026-05-27	Philips Ultrasound, LLC	reinforce	IYN	II	Radiology	EPIQ Series Diagnostic Ultrasound System
2026-05-26	GE Medical Systems Ultrasound and Primary Care Diagnostics	reinforce	IYN	II	Radiology	LOGIQ e
2026-05-22	Intuitive Surgical	reinforce	NAY	II	Gastroenterology, Urology	da Vinci Firefly Imaging System
2026-05-22	SurGenTec, LLC	reinforce	OLO	II	Neurology	Ion-C Navigation Instruments
2026-05-21	Siemens Medical Solutions USA, Inc.	reinforce	KPS	II	Radiology	Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia
2026-05-20	Varian Medical Systems	reinforce	JAQ	II	Radiology	MAASTRO Rectal Applicator Set
2026-05-18	Boston Scientific Corporation	reinforce	GEX	II	General, Plastic Surgery	MOSES Raydar
2026-05-15	Boston Scientific Corporation	reinforce	KRA	II	Cardiovascular	TruSelect 2.6 Microcatheter
2026-05-15	Fresenius Medical Care Renal Therapies Group, LLC	reinforce	KDI	II	Gastroenterology, Urology	NxStage System One with NxView
2026-05-15	Roche Molecular Systems, Inc.	reinforce	QEP	II	Microbiology	cobas liat CT/NG/MG nucleic acid test
2026-05-15	Roche Molecular Systems, Inc.	reinforce	QEP	II	Microbiology	cobas liat CT/NG nucleic acid test
2026-05-13	Merit Medical Systems, Inc.	expand	FRO	—	Unknown	StatSeal Disc
2026-05-13	CONMED Corporation	reinforce	MBI	II	Orthopedic	Y-Knotless Flex Anchors

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	JDR	Staple, Fixation, Bone	Orthopedic	0.0×	0	21
2	KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	0.0×	0	27
3	LYY	Latex Patient Examination Glove	General Hospital	0.0×	0	25
4	FYC	Gown, Isolation, Surgical	General, Plastic Surgery	0.0×	0	20
5	FLL	Continuous Measurement Thermometer	General Hospital	0.12×	2	81
6	NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	0.15×	1	33
7	MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	0.15×	2	67
8	FXX	Mask, Surgical	General, Plastic Surgery	0.19×	9	241
9	LZA	Polymer Patient Examination Glove	General Hospital	0.19×	14	369
10	QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	0.21×	1	24
11	LFL	Instrument, Ultrasonic Surgical	Unknown	0.23×	1	22
12	MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	0.23×	1	22
13	JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	0.3×	2	33
14	KGO	Surgeon'S Gloves	General, Plastic Surgery	0.31×	2	32
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.

v1+ Roadmap

📰 Coming Next — External Signal Sources

v0.5 of the Market Pulse uses FDA Radar 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.