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Recall · Boston Scientific Corporation — Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 Recall · Philips North America Llc — Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 Recall · Philips North America Llc — Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T AchiRecall · Midmark Corporation — Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic bloRecall · Philips North America Llc — Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), Recall · Philips North America Llc — Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T),Recall · Philips North America Llc — Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;Recall · Philips North America Llc — Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2Recall · Boston Scientific Corporation — Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 Recall · Philips North America Llc — Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 Recall · Philips North America Llc — Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T AchiRecall · Midmark Corporation — Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic bloRecall · Philips North America Llc — Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), Recall · Philips North America Llc — Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T),Recall · Philips North America Llc — Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;Recall · Philips North America Llc — Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2
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 I Recall
Boston Scientific Corporation
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5
Z-3214-2026
Aug 24
Class II Recall
Philips North America Llc
Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 (X), 5. 782109 (X), 6. 782138 (X);
Z-3237-2026
Aug 21
Class II Recall
Philips North America Llc
Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. Intera 1.5T Achieva Nova (781172), 5. Intera 1.5T Achieva Nova-Dual (781173), 6. Intera 1.5T Omni/Stellar (781104), 7. Intera Achieva 1.5T Pulsar (781171);
Z-3240-2026
Aug 21
Class II Recall
Midmark Corporation
Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724
Z-3220-2026
Aug 21
Class II Recall
Philips North America Llc
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0T CX), 5. 782105(3.0T CX);
Z-3238-2026
Aug 21
Class II Recall
Philips North America Llc
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (3.0T), 4. 782143 (3.0T);
Z-3235-2026
Aug 21
Class II Recall
Philips North America Llc
Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;
Z-3234-2026
Aug 21
Class II Recall
Philips North America Llc
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5T), 4. 782101(1.5T), 5. 782115(1.5T), 6. 782140(1.5T), 7. 781261(1.5T CX), 8. 781262(1.5T CX), 9. 781347(1.5T S);
Z-3236-2026
Aug 21

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