📡 2026-10-12 — 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)

4.06×

— — see below

Codes attracting new entrants

top: 39 first-timers in QIH

Top-50 incumbent moves

64 reinforce · 16 expand · 37 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	—	—	—	—	4.06×	13	16	13
2	DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	II	3.18×	7	11	2
3	OLR	Oral Wound Dressing	Unknown	—	3.0×	6	10	6
4	LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	II	3.0×	3	5	3
5	FMZ	Incubator, Neonatal	General Hospital	II	3.0×	3	5	2
6	LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	II	2.86×	4	7	4
7	GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	II	2.73×	6	11	6
8	MOF	Guide, Wire, Catheter, Neurovasculature	Cardiovascular	II	2.61×	12	23	7
9	IOR	Wheelchair, Mechanical	Physical Medicine	I	2.56×	21	41	14
10	OLI	Fat Reducing Low Level Laser	General, Plastic Surgery	II	2.5×	5	10	4
11	MMK	Container, Sharps	General Hospital	II	2.5×	5	10	5
12	SAN	Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples	Microbiology	II	2.5×	4	8	4
13	GXP	Methyl Methacrylate For Cranioplasty	Neurology	II	2.5×	4	8	2
14	OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	II	2.5×	4	8	4
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	39	3DIEMME SRLAI Planning Logic, Inc.Agada Medical, Ltd.Ai4medimaging Medical Solutions S.A.Anumana, Inc.
2	LLZ	System, Image Processing, Radiological	Radiology	38	ADVAHEALTH SOLUTIONS, LLCAS Software, LLCAgfa Healthcare N.V.Apryse Software CorpArchy Dental, Inc.
3	ITI	Wheelchair, Powered	Physical Medicine	23	Beijing OrionStar Technology Co., Ltd.Foshan Sowell Medical Technology Co., Ltd.Hebei Dansong Medical Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jiangsu Yveelt Medical Equipment Co., Ltd.
4	GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	22	Baoding Te'Anzhou Electronic Technology Co., Ltd.Beijing HuaCheng Taike Technology Co., Ltd.Boston Aesthetics, Inc.C.R. Bard, Inc.CAO Group, Inc.
5	OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	20	Atop Lighting Co., Ltd.Dongguan Miqiang Technology Co., Ltd.Dongguan Yijiaming Technology Co., Ltd.Guangdong Ace-Tec Co., Ltd.Kam Yuen Plastic Products , Ltd.
6	GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	19	Ascblue CorporationAsterasys Co., Ltd.Aventix Medical, Inc.Baylis Medical Technologies, Inc.Cynosure Lutronic Technology Corporation
7	NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	17	Allumin8, Inc.Beijing Fule Science & Technology Development Co., Ltd.Box Spine, LLCChanpin Medtak Co., Ltd.Double Medical Technology, Inc.
8	GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	16	Ab Medica SasFloShield, Inc.Freyja Healthcare, LLCHangzhou Hawk Optical Electronic Instruments Co., Ltd.Integrated Endoscopy, Inc.
9	ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	15	C.A. Medical, LLCEffortmed, LLCFims Co., Ltd.HC Biologics, LLCIntelivation Technologies
10	IOR	Wheelchair, Mechanical	Physical Medicine	13	Anhui Longway Medical Technology Co., Ltd.Empower Ride, LLCFoshan Nanhai Hongchen Medical Equipment Co., Ltd.Free Wheelchair MissionGuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd.
11	NUC	Lubricant, Personal	Obstetrics/Gynecology	13	Ansella TherapeuticsBumlicious, LLC (DBA Bumlicious)Golden Isles Medical, Inc.Guangzhou Haoyimai Trading Co., Ltd.Hudi Pharma Srl
12	INI	Vehicle, Motorized 3-Wheeled	Physical Medicine	13	Dongguan Smarfody Mobility Technology Co., Ltd.Jiangsu Intco Medical Products Co., Ltd.Jochu Technology Co., Ltd.Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.Nanjing Mijo Technology Co., Ltd.
13	—	—	—	13	41Medical AGBiotracker, LLCCepheidDiazyme Laboratories, Inc.Fit-Pro KFT (Ltd.) - DBA E-Fit
14	FRO	Dressing, Wound, Drug	Unknown	12	ACTO GmbHBeijing Kreate Medical Co., Ltd.Huizhou Foryou Medical Co., Ltd.InnovaCorium, Inc.Letus Corporation
15	DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	12	80 Beats Medical GmbHBeijing Hanvon Health Technology Co., Ltd.Biozen, LLCGuangzhou Daxin Health Technology Co., Ltd.Happy Health, 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: 64 reinforce moves vs 16 expand moves · 80% reinforce · 20% expand · 37 of 50 incumbents active in window

Date	Firm	Move	Code	Class	Specialty	Device
2026-09-25	Siemens Medical Solutions USA, Inc.	reinforce	QIH	II	Radiology	syngo.CT Brain Quantification
2026-09-25	Arthrex, Inc.	reinforce	HWC	II	Orthopedic	Arthrex Beaming System
2026-09-25	Philips Ultrasound, LLC	reinforce	IYN	II	Radiology	EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diag
2026-09-24	Arthrex, Inc.	reinforce	MRW	—	Unknown	Arthrex Spine Compression FT Screw
2026-09-24	Zimmer, Inc.	reinforce	PKC	II	Orthopedic	OsseoFit Stemless Shoulder System
2026-09-21	Beckman Coulter, Inc.	reinforce	NBC	II	Clinical Chemistry	Access NT-proBNP
2026-09-18	Inari Medical, Inc.	reinforce	QEW	II	Cardiovascular	Triever Duo Catheter
2026-09-18	Nvision Biomedical Technologies	reinforce	HRS	II	Orthopedic	EnHAnce PEEK Bunion System
2026-09-17	Medtronic, Inc.	expand	FGE	II	Gastroenterology, Urology	Protégé EverFlex Self-expanding Peripheral Stent System
2026-09-17	Abbott Medical	reinforce	DQK	II	Cardiovascular	EnSite X EP System
2026-09-17	SurGenTec, LLC	expand	GZT	II	Neurology	Durashield Device Kit
2026-09-16	GE Medical Systems Ultrasound and Primary Care Diagnostics	reinforce	QIH	II	Radiology	EchoPAC Software Only / EchoPAC Plug-in (v211)
2026-09-15	Covidien, LLC	reinforce	GEI	II	General, Plastic Surgery	LigaSure RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated
2026-09-14	Becton Dickinson and Company	expand	JTZ	II	Microbiology	BD BBL Mueller Hinton II Broth (Cation-Adjusted); BD Difco Mueller Hin
2026-09-11	Boston Scientific Corporation	reinforce	OVB	II	Radiology	SpaceOAR Flex System
2026-09-10	Siemens Medical Solutions USA, Inc.	reinforce	OBJ	II	Cardiovascular	ACUNAV Luxera 4D ICE Catheter
2026-09-08	Intuitive Surgical, Inc.	reinforce	NAY	II	Gastroenterology, Urology	da Vinci Surgical System, Model IS5000
2026-09-08	Smith & Nephew, Inc.	reinforce	MBH	II	Orthopedic	LANDMARK Total Knee System
2026-09-04	Dentsply Sirona, Inc.	reinforce	KCT	II	General Hospital	Surgical and Prosthetic Trays
2026-09-03	Boston Scientific	reinforce	KNS	II	Gastroenterology, Urology	Rezum System
2026-09-02	GE Medical Systems Ultrasound and Primary Care Diagnostics	reinforce	IYN	II	Radiology	Vivid Explorer/Vivid Advanced/Vivid Focus
2026-09-02	Hologic, Inc.	expand	MUE	II	Radiology	I-View®
2026-09-01	Arthrex, Inc.	reinforce	JDR	II	Orthopedic	Arthrex DynaNite Staples
2026-08-31	Siemens Medical Solutions USA, Inc.	reinforce	KPR	II	Radiology	MULTIX Impact; MULTIX Impact C
2026-08-28	Medtronic, Inc.	reinforce	MXD	II	Cardiovascular	LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)

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	OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	0.0×	0	22
2	LYY	Latex Patient Examination Glove	General Hospital	0.0×	0	22
3	LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	0.0×	0	23
4	FLL	Continuous Measurement Thermometer	General Hospital	0.15×	2	67
5	FRC	Indicator, Biological Sterilization Process	General Hospital	0.19×	1	27
6	FXX	Mask, Surgical	General, Plastic Surgery	0.22×	8	181
7	LFL	Instrument, Ultrasonic Surgical	Unknown	0.24×	1	21
8	MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	0.24×	3	63
9	ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	General, Plastic Surgery	0.25×	1	20
10	JSM	Culture Media, Non-Propagating Transport	Microbiology	0.25×	1	20
11	LZA	Polymer Patient Examination Glove	General Hospital	0.25×	17	335
12	JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	0.31×	2	32
13	ODC	Endoscope Channel Accessory	Gastroenterology, Urology	0.33×	2	30
14	NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	0.33×	2	30
15	FRN	Pump, Infusion	General Hospital	0.33×	2	30

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

2026-10-11 — AnX Robotica Highlights Documented ProScan AI Workflow Performance from Submission to FDA
2026-10-10 — RingConn Receives FDA 510(k) Clearance for Non-Invasive Blood Oxygen (SpO2) Measurement
2026-10-10 — First Patient Dosed in Phase III Perioperative Study of Cadonilimab (PD-1/CTLA-4) in Colon Cancer
2026-10-10 — Haag-Streit USA and Marco Lombart launch Octopus 910 in the US at AAO 2026 in New Orleans
2026-10-09 — MIDEA COMPLETES THE ACQUISITION OF ESAOTE
2026-10-09 — MIDEA COMPLETES THE ACQUISITION OF ESAOTE

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.