📡 2026-05-30 — 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: 37 first-timers in QIH

Top-50 incumbent moves

65 reinforce · 12 expand · 35 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	KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	II	3.33×	4	6	4
3	SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	II	3.18×	7	11	6
4	QSM	System, Surgical, Computer Controlled Instrument, Remanufactured	Gastroenterology, Urology	II	3.13×	5	8	2
5	KRH	Ring, Annuloplasty	Cardiovascular	II	3.13×	5	8	4
6	PZM	Next Generation Sequencing Based Tumor Profiling Test	Pathology	II	3.0×	3	5	3
7	POS	Physiological Signal Based Seizure Monitoring System	Neurology	II	3.0×	3	5	3
8	QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software	Cardiovascular	II	3.0×	3	5	3
9	QVP	Sars-Cov-2 Serology Test	Microbiology	II	3.0×	3	5	1
10	LNS	Lithotriptor, Extracorporeal Shock-Wave, Urological	Gastroenterology, Urology	II	3.0×	3	5	2
11	LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	II	3.0×	3	5	2
12	LYC	Bone Grafting Material, Synthetic	Dental	II	2.86×	4	7	3
13	FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	II	2.86×	4	7	2
14	DXT	Injector And Syringe, Angiographic	Cardiovascular	II	2.69×	7	13	6
15	MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	II	2.5×	9	18	6

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.Audax D.O.O.Avatar Medical
2	GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	34	Baoding Te'Anzhou Electronic Technology Co., Ltd.Beijing HuaCheng Taike Technology Co., Ltd.Beijing Superlaser Technology Co., Ltd.Bellamia Technologies, Inc.Boston Aesthetics, Inc.
3	LLZ	System, Image Processing, Radiological	Radiology	32	AS Software, LLCAgfa Healthcare N.V.Archy Dental, Inc.Artiness S.R.LAugmented Reality Software S.L.
4	OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	24	Atop Lighting Co., Ltd.Dongguan Yanxi Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Foshan Guangyu Weilai Medical Equipment Co., Ltd.Guangdong Ace-Tec Co., Ltd.
5	ITI	Wheelchair, Powered	Physical Medicine	20	Beijing OrionStar Technology Co., Ltd.Hebei Dansong Medical Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jinhua Qidian Vehicle Co., Ltd.Nanjing CareMoving Rehabilitation Equipment 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	15	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.Jiangxi Jiangte Electric Vehicle Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.
10	FRO	Dressing, Wound, Drug	Unknown	12	Beijing Kreate Medical Co., Ltd.Huizhou Foryou Medical Co., Ltd.Infection Elimination Solutions, LLCInnovaCorium, Inc.Letus Corporation
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	DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	11	Aktiia SABeijing Hanvon Health Technology Co., Ltd.Biozen, LLCCardio Ring Technologies, Inc. Taiwan BranchCemho Medical Technology (Guangdong) Co., Ltd.
13	NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	11	Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCDouble Medical Technology, Inc.Globus Medical, Inc.
14	OLO	Orthopedic Stereotaxic Instrument	Neurology	11	Balmoral Medical, LLCEvolution SpineFoundation Surgical Group, Inc.K2m, Inc.Orthofix US, LLC
15	HRS	Plate, Fixation, Bone	Orthopedic	10	Actis Medical Pty., Ltd.Chest Wall Innovations, Inc.Genostis AFGm Dos Reis Industria E ComercioHyperflex Medical

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: 65 reinforce moves vs 12 expand moves · 84% reinforce · 16% expand · 35 of 50 incumbents active in window

Date	Firm	Move	Code	Class	Specialty	Device
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
2026-05-14	TriMed, Inc.	reinforce	HWC	II	Orthopedic	TriMed Compression Screws
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
2026-05-12	Life Spine, Inc.	reinforce	MAX	II	Orthopedic	VersaLift Expandable System
2026-05-08	Arthrex, Inc.	reinforce	HWC	II	Orthopedic	Arthrex Beaming System
2026-05-07	Globus Medical, Inc.	reinforce	NKB	II	Orthopedic	SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization Syste
2026-05-05	Philips Ultrasound, LLC	reinforce	IYN	II	Radiology	Lumify Diagnostic Ultrasound System
2026-05-01	Steris	expand	SHM	—	—	Prolystica Pass Thru Disinfectant Wipes
2026-05-01	Covidien, LLC	reinforce	CCK	II	Anesthesiology	Capnostream35 Portable Respiratory Monitor (PM35MN)
2026-04-29	Siemens Medical Solutions USA, Inc.	reinforce	QIH	II	Radiology	syngo Application Software
2026-04-29	Globus Medical, Inc.	reinforce	OVD	II	Orthopedic	SCRIPT Implant System
2026-04-27	Zimmer, Inc.	reinforce	LZO	II	Orthopedic	Avenir® Müller Stem; Avenir Complete Hip System
2026-04-24	Siemens Medical Solutions USA, Inc.	reinforce	OWB	II	Radiology	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phe
2026-04-24	ABBOTT MEDICAL	reinforce	NQQ	II	Radiology	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imag
2026-04-24	Globus Medical, Inc.	reinforce	HSB	II	Orthopedic	AUTOBAHN Nailing System
2026-04-24	Roche Diagnostics GmbH	expand	JKR	II	Clinical Chemistry	Elecsys Calcitonin
2026-04-24	Penumbra, Inc.	reinforce	QEW	II	Cardiovascular	INDIGO® Aspiration System INDIGO Link
2026-04-23	Siemens Medical Solutions USA, Inc.	reinforce	OWB	II	Radiology	ARTIS genio floor; ARTIS icono.explore floor
2026-04-23	Medtronic, Inc.	reinforce	DWF	II	Cardiovascular	Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae
2026-04-23	Varian Medical Systems, Inc.	reinforce	LHN	II	Radiology	ProBeam 360 Proton Therapy System v3.0
2026-04-23	Dentsply Sirona	reinforce	QIH	II	Radiology	DS Core CBCT Anatomy

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	LYY	Latex Patient Examination Glove	General Hospital	0.0×	0	25
3	JDR	Staple, Fixation, Bone	Orthopedic	0.0×	0	21
4	KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	0.0×	0	28
5	KGO	Surgeon'S Gloves	General, Plastic Surgery	0.15×	1	33
6	NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	0.15×	1	33
7	FLL	Continuous Measurement Thermometer	General Hospital	0.18×	3	83
8	QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	0.21×	1	24
9	FXX	Mask, Surgical	General, Plastic Surgery	0.21×	11	264
10	LZA	Polymer Patient Examination Glove	General Hospital	0.21×	16	376
11	MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	0.22×	1	23
12	MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	0.22×	3	68
13	IPF	Stimulator, Muscle, Powered	Physical Medicine	0.29×	2	34
14	QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	0.34×	2	29
15	PGY	Display, Diagnostic Radiology	Radiology	0.34×	3	44

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.

Firm	Country	Code	Total US Clearances	Class I Recalls	Last Clearance	Last Recall
Cook Incorporated	US	MQK	6	3 C1	2024-03-08	2026-04-02
Cook Incorporated	US	MMX	6	3 C1	2024-03-08	2026-04-02
Cook Incorporated	US	DRE	6	3 C1	2024-03-08	2026-04-02
Cook Incorporated	US	LJE	6	3 C1	2024-03-08	2026-04-02
Cook Incorporated	US	DYB	6	3 C1	2024-03-08	2026-04-02
Cook Incorporated	US	OQY	6	3 C1	2024-03-08	2026-04-02

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.