MAXIMA BIOTECHMaxima Biotech · Investor Relations Public · Investors 中文EN
COMPETITIVE WATCH · Patent monitoring + intelligence gathering

Unmet clinical needs drive incumbents to keep innovating,
and our proprietary competitive-intelligence platform proactively surfaces white space

Data is captured first-hand from the FDA / USPTO / EPO / JPO / TIPO official databases, then desensitized and synced to this page.

The same monitoring capability is split into two sub-systems: the Patent Monitoring System — automatically tracking patent status across Taiwan / US / EU / Japan; and the Intelligence Gathering System — automatically comparing the public US FDA records of major competitors. Every incumbent innovation and every public filing is first-hand intelligence for strengthening our product roadmap and white-space markets.

What this monitoring means for investors

This system is not "patent news" — it is a live operations console directly tied to Maxima's operational risk and growth headroom. Three things matter most for investment judgment:

① Protect Freedom to Operate (FTO)
Track the expiry timeline of "blocking patents" in real time, turning "when we can enter / sell" into a plannable schedule — this dictates the cadence of Maxima's product and market entry, and is the basis for assessing growth predictability.
② Surface product-roadmap white space
Every new publication or grant by a competitor is first-hand intelligence on "what the market still lacks." Maxima uses this to strengthen its roadmap and white-space markets rather than investing blindly.
③ Competitive risk early-warning
Competitors' recalls, adverse events, clearances and registrations at the US FDA are compared automatically each cycle. This lets us (and investors) grasp the competitive landscape and potential risks in real time, rather than learning after the fact.

Bottom line: the "cleaner" the monitoring result (no WARNING / CRITICAL), the more stable Maxima's freedom to operate and competitive position. Once a high-severity alert appears, it signals that timelines, roadmap, or risk need re-assessment. The two sub-systems below handle "patent status" and "competitor FDA public records" respectively.

Who we monitor (21 parties · three market-access groups)

This list applies to both the Patent Monitoring System and the Intelligence Gathering System below — two views of the same set of parties: patent status and blocking vs. public FDA records.

The market is defined as the union of FDA (510(k) population) + CE-mark holders + NMPA China registrants. Key named rivals (the rest appear in the alert table and citation network below):

J&J / Ethicon / Cilag Medtronic / Covidien Olympus Stryker Erbe (holds CE) Integra (CUSA Clarity) SRA Developments (LOTUS) Tenex Health (Trice) Chinese makers with a US 510(k) (e.g. Surgnova) Ultrasonic bone-cutting cohort (Orthosonics / Piezosurgery) Unnamed new entrants

How to read these numbers

How the "broad search" works

Keywords are defined first — Taiwan searches ultrasonic scalpel / transducer / handle / cutting / coagulation / bone blade / instrument / surgical; the US searches ultrasonic scalpel / blade / cautery / surgical / effector plus classifications A61B17/32 and A61B18/14. A record counts only if its title hits too. Caught does not mean relevant — reference only.

Two terms not to confuse

A monitored entity is a party we track (21 in total, merged across FDA·CE·NMPA tracks); an entity-layer target is the number of patents under those parties. Different things.

How new entrants surface

We look at who cites the incumbents' early patents: citing early = established rival; filing after those patents published and then citing = a new entrant coming in. This step only answers "who showed up" — not a blocking list; actual blocking requires a separate item-by-item comparison (see "blocking us now").

Patent Monitoring System

Automatically tracks patent status across Taiwan / US / EU / Japan: detects status changes, upcoming expiries, reinstatement windows and blocking events in real time. The figures below are synced from official patent databases; every record links back to the official page via "Verify".

Latest comparison Loading source…

Data is pulled automatically from the public databases of the Taiwan, US, European and Japanese patent offices and re-compared each cycle. This page connects to no internal database.

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Patents under watch
(TW/US/CA/EP/JP)
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Blocking us right nowDecides directly whether that market can be sold into today
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Held by named competitorsRivals we track by name; more targeted, worth more attention than the broad sweep
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Could be revivedLapsed but lawfully revivable; once revived, that market's opening date moves later
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Swept up by broad searchKeyword candidates, not yet checked one by one; reference only
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Our ownPatents we hold; not a risk
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Changed this cycleStatus, expiry, reinstatement-window and blocking-event changes
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Last compared
The five classes above do not overlap and add up to the monitored total; the earlier in the list, the more it matters.
Colour: blue = info, yellow = notice, orange = warning, red = critical — the redder, the more it matters Event: what happened in this record Verify: click the patent number or "Verify" to open the official record; the record is the evidence — we do not interpret it for you
LevelTimeEventPatentPatent holderTitleDescriptionVerify
BLOCK2026-10-12Blocking patentEP3263055B1Syntheon/Covidien(Medtronic)—Markets: DE, FR, GB; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentUS10799913B2COVIDIEN AG—Markets: US; rights expiry: 2032-01-13Google Patents ↗
BLOCK2026-10-12Blocking patentUS8403949B2COVIDIEN AG—Markets: US; rights expiry: 2030-09-04Google Patents ↗
BLOCK2026-10-12Blocking patentUS8461744B2CILAG GMBH INTERNATIONAL—Markets: US; rights expiry: 2029-09-11Google Patents ↗
BLOCK2026-10-12Blocking patentUS11478820B2COVIDIEN AG—Markets: US; rights expiry: 2028-12-09Google Patents ↗
BLOCK2026-10-12Blocking patentEP2510891B1Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2032-04-15Google Patents ↗
BLOCK2026-10-12Blocking patentEP2422721B1Covidien(Medtronic)—Markets: GB, DE, FR, AT; rights expiry: 2031-08-25Google Patents ↗
BLOCK2026-10-12Blocking patentEP2453813B1Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2030-07-10Google Patents ↗
BLOCK2026-10-12Blocking patentEP3263054B1Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2030-07-10Google Patents ↗
BLOCK2026-10-12Blocking patentEP3524189B1Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2030-07-10Google Patents ↗
BLOCK2026-10-12Blocking patentEP2229104B1Syntheon/Covidien(Medtronic)—Markets: GB, DE, FR, AT; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentEP2433577B1Syntheon/Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentEP2433578B1Syntheon/Covidien(Medtronic)—Markets: GB, DE, FR; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentEP3398540B1Covidien(Medtronic)—Markets: DE, FR, AT; rights expiry: 2031-08-25Google Patents ↗
BLOCK2026-10-12Blocking patentAU2008334050B2Syntheon/Covidien(Medtronic)—Markets: AU; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentAU2013207564B2Covidien(Medtronic)—Markets: AU; rights expiry: 2028-12-01Google Patents ↗
BLOCK2026-10-12Blocking patentAU2017203336B2Covidien(Medtronic)—Markets: AU; rights expiry: 2031-08-24Google Patents ↗
BLOCK2026-10-12Blocking patentJP6081561B2Ethicon(J&J)—Markets: JP; rights expiry: To be verifiedGoogle Patents ↗
BLOCK2026-10-12Blocking patentUS9414853ETHICON ENDO-SURGERY, INC.—Markets: US; rights expiry: To be verifiedGoogle Patents ↗
BLOCK2026-10-12Blocking patentUS9168055Ethicon Endo-Surgery, Inc.—Markets: US; rights expiry: To be verifiedGoogle Patents ↗
BLOCK2026-10-12Blocking patentUS9724120Ethicon Endo-Surgery, Inc.—Markets: US; rights expiry: To be verifiedGoogle Patents ↗

Intelligence Gathering System

Major competitors' public records at the US FDA — MAUDE adverse events, recalls, 510(k) clearances, GUDID listings / delistings, establishment registrations & device listings, enforcement reports and warning letters — compared automatically each cycle.

At a glance

The panel below is the intelligence system at a glance: current record counts per source, the alerts surfaced in the latest comparison, and known limits; every alert links to the official query for verification.

Latest records and this round's alerts (ultrasonic-scalpel related only)

Rows are the latest official record in each source, limited to ultrasonic-scalpel products (brands HARMONIC / SONICISION / THUNDERBEAT, product codes LFL / GEI / NLQ, or an ultrasonic-description match for enforcement reports); records that cannot be confirmed as ultrasonic-scalpel are omitted. Rows after those are the alerts surfaced in the latest intelligence comparison (event types shown as plain-language names). Levels are a display convention (Warning letter = WARNING; recall / enforcement / GUDID withdrawn / alert = NOTICE; others = INFO), not our assessment. Click a row's link to open the official query and verify. This table contains no assessment or interpretation by us. Retrieved at 2026-10-22T09:27:11.

LevelEvent typeContent
INFOMAUDE eventsJ&J/Ethicon(Harmonic) · HARMONIC · 2026-09-30 · 編號 3005075853-2026-08108 official query ↗
NOTICERecallsJ&J/Ethicon(Harmonic) · LFL · 2021-07-20 · 編號 Z-2355-2021 official query ↗
INFO510(k) clearanceJ&J/Ethicon(Harmonic) · GEI · 2026-09-17 · 編號 K254196 official query ↗
INFOGUDID listedJ&J/Ethicon(Harmonic) · Harmonic · 2024-03-01 · 編號 HAR745 official query ↗
NOTICEGUDID withdrawnJ&J/Ethicon(Harmonic) · Harmonic · 2023-04-04 · 編號 HST01 official query ↗
NOTICEEnforcementJ&J/Ethicon(Harmonic) · HARMONIC HD 1000i Shears (20cm Shaft Length) · 2021-09-01 · 編號 Z-2355-2021 official query ↗
INFOMAUDE eventsMedtronic/Covidien(Sonicision) · SONICISION · 2026-09-30 · 編號 1717344-2026-01343 official query ↗
NOTICERecallsMedtronic/Covidien(Sonicision) · GEI · 2023-11-16 · 編號 Z-0631-2024 official query ↗
INFO510(k) clearanceMedtronic/Covidien(Sonicision) · GEI · 2026-09-15 · 編號 K261070 official query ↗
INFOGUDID listedMedtronic/Covidien(Sonicision) · Sonicision · 2022-09-22 · 編號 SCD391 official query ↗
NOTICEGUDID withdrawnMedtronic/Covidien(Sonicision) · Sonicision · 2025-09-18 · 編號 SCT12 official query ↗
NOTICEEnforcementMedtronic/Covidien(Sonicision) · Covidien Sonicision Battery Charger-intended · 2021-12-15 · 編號 Z-0332-2022 official query ↗
WARNINGWarning lettersMedtronic/Covidien(Sonicision) · SONICISION · 2021-12-28 · 編號 12/28/2021 official query ↗
INFOMAUDE eventsOlympus(Thunderbeat) · THUNDERBEAT · 2026-09-28 · 編號 9614641-2026-00962 official query ↗
NOTICERecallsOlympus(Thunderbeat) · GEI · 2026-08-18 · 編號 Z-3035-2026 official query ↗
INFO510(k) clearanceOlympus(Thunderbeat) · GEI · 2026-07-01 · 編號 K254056 official query ↗
INFOGUDID listedOlympus(Thunderbeat) · THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm · 2025-12-04 · 編號 TB2-0545FC official query ↗
NOTICEGUDID withdrawnOlympus(Thunderbeat) · THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip · 2025-11-24 · 編號 TB-0520FC official query ↗
NOTICEEnforcementOlympus(Thunderbeat) · Olympus Thunderbeat II Shears w/Ultrasonic M · 2026-04-29 · 編號 Z-1854-2026 official query ↗
WARNINGWarning lettersOlympus(Thunderbeat) · THUNDERBEAT · 2026-10-20 · 編號 10/20/2026 official query ↗
NOTICERecallsStryker · GEI · 2026-06-08 · 編號 Z-2865-2026 official query ↗
INFO510(k) clearanceStryker · LFL · 2026-10-08 · 編號 K262244 official query ↗
INFOGUDID listedStryker · 超音波刀(描述命中) · 2024-03-04 · 編號 HAR1136 official query ↗
NOTICEGUDID withdrawnStryker · SonicFusion · 2024-12-16 · 編號 0019102000 official query ↗
NOTICEEnforcementStryker · HARMONIC FOCUS Shears + Adaptive Tissue Tech · 2025-11-19 · 編號 Z-0490-2026 official query ↗
NOTICERecallsIntegra/Misonix(CUSA) · LFL · 2026-03-06 · 編號 Z-1828-2026 official query ↗
INFO510(k) clearanceIntegra/Misonix(CUSA) · LFL · 2026-07-30 · 編號 K261448 official query ↗
INFOGUDID listedIntegra/Misonix(CUSA) · neXus · 2020-02-24 · 編號 100-10-0000 official query ↗
NOTICEGUDID withdrawnIntegra/Misonix(CUSA) · CUSA® NXT · 2024-11-20 · 編號 NXT3219 official query ↗
NOTICEEnforcementIntegra/Misonix(CUSA) · CUSA Clarity C7000 Console, Software Version · 2026-04-29 · 編號 Z-1828-2026 official query ↗
INFO510(k) clearanceSRA Developments(LOTUS) · LFL · 2022-12-15 · 編號 K221102 official query ↗
NOTICERecallsTenex Health/Trice Medical · LFL · 2014-04-14 · 編號 Z-1552-2014 official query ↗
INFO510(k) clearanceTenex Health/Trice Medical · LFL · 2024-11-18 · 編號 K241700 official query ↗
NOTICEEnforcementTenex Health/Trice Medical · TX1 Tissue Removal System. TX1 Procedure Pa · 2014-05-14 · 編號 Z-1552-2014 official query ↗
INFO510(k) clearanceErbe · GEI · 2025-12-18 · 編號 K253915 official query ↗
NOTICEClinical-pain keyword surge[Harmonic (Ethicon)] 臨床痛點關鍵詞升溫:BROKEN TIP(刀頭斷裂)
近 12 個月(20250623~20260623)命中 19 件,前一期同長度窗口 7 件(比值 2.71)。⚠ MAUDE 多為原廠自通報(Harmonic 全期 OTHER 47,595 件 vs PHYSICIAN 1,961 件),此為競品自家客訴帳之變化,宜與失效模式碼併讀。
 official query ↗

Glossary

One-line explanations of the agencies and public-record terms appearing on this page.

Data-source agencies

FDAUS Food & Drug Administration
The US medical-device authority — device US market entry and post-market reporting fall under it; its public databases are the first-hand source for this page's intelligence.
USPTOUS Patent & Trademark Office
The US patent authority; US patent grants, assignments and expiry status are authoritative here.
EPOEuropean Patent Office
The authority for European patents; responsible for examination and grant.
JPOJapan Patent Office
The Japanese patent authority.
TIPOTaiwan IP Office
The Taiwanese patent authority.

FDA public-record terms

MAUDE Adverse EventAdverse event
FDA's medical-device adverse-event reporting database; a report does not establish causation — it only indicates that something occurred.
RecallRecall
Action to retrieve, correct or remove a marketed device; FDA classifies by hazard level.
510(k) ClearancePremarket notification
The main US pathway for low-to-moderate-risk devices — demonstrating substantial equivalence to a predicate; it is not FDA endorsing efficacy.
GUDID Listing / DelistingUDI database
FDA's Unique Device Identifier (UDI) database — listing = model registered and marketable; delisting = that model's record stopped or market withdrawn.
Registration & ListingRegistration & Listing
A firm registers its establishment with FDA and lists the products it sells in the US; listing is not approval.
Enforcement ReportsEnforcement Reports
FDA's periodically published recall enforcement reports, itemizing firm, product, reason, quantity and classification.
Warning LetterWarning Letter
A formal letter FDA sends a firm after finding significant violations during inspection; content is public on FDA's site.

The above are term definitions based on each agency's public information; this page does not judge the cause of any individual recall, report or letter.