Live wire
Recall · Steris Corporation — HexaVue Focus Integration System, a single, all-in-one system that handles operating room Recall · NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Recall · Nihon Kohden America LLC — Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CRecall · Draeger, Inc. — VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathiRecall · Beckman Coulter Inc. — DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISRecall · Beckman Coulter Inc. — DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C635Recall · Safeguard US Operating LLC — Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IRecall · Mindray DS USA, Inc. — BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.Recall · Steris Corporation — HexaVue Focus Integration System, a single, all-in-one system that handles operating room Recall · NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Recall · Nihon Kohden America LLC — Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CRecall · Draeger, Inc. — VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathiRecall · Beckman Coulter Inc. — DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISRecall · Beckman Coulter Inc. — DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C635Recall · Safeguard US Operating LLC — Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IRecall · Mindray DS USA, Inc. — BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Tinnitus Management: Navigating a Fragmented Device Landscape
EvidenceCdevices

Cover story · Jul 12

Tinnitus Management: Navigating a Fragmented Device Landscape

Recent advances in tinnitus treatment emphasize combination therapies and neuromodulation, yet sustained relief remains an elusive goal for many patients, highlighting the need for more robust clinical evidence.

ProjMed Editorial Desk·7 min read

Read through the lens of

Editorial synthesis

Current tinnitus management strategies frequently combine sound therapy, counseling, and neuromodulation techniques. Clinicians should evaluate devices based on their evidence for sustained efficacy, particularly in reducing tinnitus loudness and improving quality of life (e.g., THI scores). Safety profiles of non-invasive neuromodulation devices are generally favorable, but trials often show a significant placebo effect. Understanding the specific auditory and neurological profiles of patients may help in tailoring treatment choices, though definitive biomarkers remain elusive.

The ProjMed twist · 01

One story. Three expert lenses.

Every article is rewritten in real time for the reader in the room — clinician, investor, or patient. Same facts, same citations, different depth.

01Evidence-first

Clinician

Trial design, endpoints, dosing, safety signals — the way a fellow would brief you.

Sample takeaway

Endpoint hit, but Kaplan-Meier separation only after month 6.

02Financial impact

Investor

Revenue impact, competitive moat, reimbursement pathway, pipeline overlap.

Sample takeaway

Every 100 bps of penetration = ~$85M in incremental FY revenue.

03Accessible

Patient

Plain-language explanations, real-world availability, questions to ask your care team.

Sample takeaway

Covered by most commercial plans; ask about the specific catheter used.

The ProjMed twist · 02

Regulatory radar

FDA 510(k) clearances and device recalls — streamed directly from openFDA, the FDA's official public data API. Every row links to the primary record.

Source · openFDA
Type
Sponsor
ID
When
Class II Recall
Steris Corporation
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control, Software Version: 2.0.18
Z-0118-2027
Sep 23
Class II Recall
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Z-3306-2026
Sep 14
Class II Recall
Nihon Kohden America LLC
Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor. Component: No
Z-0089-2027
Sep 8
Class I Recall
Draeger, Inc.
VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.
Z-3252-2026
Sep 3
Class II Recall
Beckman Coulter Inc.
DxC 500 AU Clinical Chemistry Analyzers: 1. AU w/out ISE, Part No. C63519 2. AU w/ISE, Part No. C63520
Z-0084-2027
Sep 2
Class II Recall
Beckman Coulter Inc.
DxC 500i Clinical Analyzer Modules: 1. DxC 500 AU Module w/ISE, DxC 500i, Part No. C63522 2. DxC 500 AU Module, DxC 500i, Part No. C63521 3. Access 2 Module, DxC 500i, Part No. C13252
Z-0083-2027
Sep 2
Class II Recall
Safeguard US Operating LLC
Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK Bag, Intermediate, Black - Stocked, 81-133-BL; IFAK Bag, Intermediate, Coyote Brown - Stocked, 81-133-CB; IFAK Bag, Intermediate, Multicam - Stocked, 81-133-MC; IFAK Bag, Advanced, Black - Stocked, 81-135-BL; IFAK Bag, Advanced, Multicam - Stocked, 81-135-MC; LEO Patrol Kit, 81-139; IFAK Refill, 81-301; IFAK Resupply, 81-303-01; IFAK Resupply - CS/30, 81-303-30; K9 Trauma Kit, 81-605; Medic Enhancement Set, 82-504-03; Medic Enhancement Resupply, 82-504-05; Emergency Trauma Kit, 82-520; First Responder - Intermediate, Coyote Brown, 83-303; First Responder, Intermediate, Black, 83-303-BL; DC-First Responder - Intermediate - Foliage Green, 83-303-FG; First Responder, Intermediate, Multicam, 83-303-MC; First Responder - Advanced- Coyote Brown, 83-305-CB; Combat Life Saver - Intermediate - Coyote Brown, 83-323-CB; Combat Life Saver - Intermediate - Multicam, 83-323-MC; Multi Mission, Advanced, Black - Stocked, 84-446-01-BL; Multi Mission, Advanced, Coyote Brown - Stocked, 84-446-01-CB; Multi Mission, Advanced, Multicam - Stocked, 84-446-01-MC; Direct Action Bag, Coyote Brown, Advanced, Stocked, 84-497-CB; DC-DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED, 84-497-FG; Direct Action Bag, Multicam, Advanced, Stocked, 84-497-MC; Bleeding Control Kit - Advanced, Stocked, 87-155; Stop the Bleed Kit (NJSP), 87-232; Patrol Officer IFAK - Basic, 88-105-01; Patrol Officer IFAK - Advanced, 88-105-03; High Threat Kit - Basic, 88-108-01; High Threat Kit - Intermediate, 88-108-02; High Threat Kit - Advanced, 88-108-03; High Threat Kit - PS, 88-108-05; Micro Trauma Kit (without Tourniquet), Black, 88-147; SDR EDC v1 - OTC, SDR-EDC1OTC; DC-SDR EDC v1 - OTC, SDR-EDC1-OTC; SDR Tactical Battle Belt IFAK - OTC - Black, SDR-TBBOTC; DC-SDR Tactical Battle Belt IFAK - OTC, SDR-TBB-OTC; SDR Tactical Battle Belt IFAK - OTC - Coyote Brown, SDR-TBBOTC-CB; Emergency Trauma Kit (Employee only kit), SG0999/COM
Z-0081-2027
Sep 2
Class III Recall
Mindray DS USA, Inc.
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Z-0110-2027
Aug 31

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