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Recall · NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Recall · Draeger, Inc. — VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathiRecall · Philips North America — SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XRRecall · Philips North America — Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;Recall · Philips North America — Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (SRecall · Philips North America — Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 Recall · Philips North America — Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE)Recall · Philips North America — SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11,Recall · NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Recall · Draeger, Inc. — VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathiRecall · Philips North America — SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XRRecall · Philips North America — Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;Recall · Philips North America — Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (SRecall · Philips North America — Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 Recall · Philips North America — Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE)Recall · Philips North America — SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11,
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
NOXBOX LTD
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Z-3306-2026
Sep 14
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
Philips North America
SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, and SmartPath to Ingenia Elition X; Model number (REF): 1. 781260 (1.5T), 2. 782112 (1.5T), 3. 782146 (1.5T), 4. 782165 (1.5T), 5. 782145 (3.0T), 6. 782164 (3.0T), 7. 781270 (XR and 3.0T), 8. 782113 (XR and 3.0T), 9. 782129 (XR and 3.0T), 10. 782118 (Ingenia Elition X), 11. 782144 (Ingenia Elition X), 12. 782163 (Ingenia Elition X); Software Versions: R11, R12 and R13;
Z-3314-2026
Aug 28
Class II Recall
Philips North America
Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;
Z-3317-2026
Aug 28
Class II Recall
Philips North America
Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106 (S), 3. 782137 (S), 4. 782157 (S), 5. 781358 (X), 6. 782107 (X), 7. 782119 (X), 8. 782136 (X), 9. 782158 (X), 10. 782198 (X); Software Versions: R11, R12 and R13;
Z-3311-2026
Aug 28
Class II Recall
Philips North America
Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
Z-3310-2026
Aug 28
Class II Recall
Philips North America
Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192 (XE); Software Versions: R11, R12 and R13;
Z-3307-2026
Aug 28
Class II Recall
Philips North America
SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11, R12 and R13;
Z-3315-2026
Aug 28

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