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TheBrief.Health

Technology at the bedside

Innovation & Devices

Medical devices, diagnostics, digital health and AI tools moving from pipeline into practice.

A Luna G3 positive airway pressure device being checked against a recall notice in a sleep clinic.

Innovation & Devices

Luna G3 APAP Recall: Identifying Patients at Risk

An FDA Class I recall covers Luna G3 APAP model LG3600 with specified firmware. Clinicians and suppliers need to identify exposed patients and protect continuity of positive airway pressure therapy.

Rayan Salih · September 25, 2026 · 6 min

An Astral ventilator beside checked backup equipment and a device inventory label in a respiratory care setting.

Innovation & Devices

Astral Ventilator Recall and Supercapacitor Failure Risk

Certain ResMed Astral 100 and 150 ventilators require correction because supercapacitor leakage may contribute to failure. Ventilator-dependent patients need prompt device checks and reliable backup plans.

Rayan Salih · 6 min read

Impella console and packaged pump sets arranged for a hospital inventory safety review.

Innovation & Devices

Impella CP Recall Demands Pump-Set Contingency Plans

A Class I recall of certain Impella CP SmartAssist sets follows persistent low-purge-pressure alarms that may interrupt support. Hospitals should identify affected inventory and plan for monitored pump exchange.

Rayan Salih · 6 min read

A small continuous glucose sensor attached to a child’s upper arm beside a smartphone displaying a simple glucose trend.

Innovation & Devices

Dexcom Stelo Is First OTC Glucose Monitor for Children

The FDA has cleared Dexcom Stelo for over-the-counter use in people aged 2 years and older who do not use insulin, extending nonprescription continuous glucose monitoring to children.

Rayan Salih · 6 min read

Packaged vascular devices being checked against a recall notice in a hospital supply area

Innovation & Devices

ENROUTE Class I Recall Requires Immediate Lot Review

Specified ENROUTE neuroprotection system lots were recalled after arterial sheath tip separation reports. Transcarotid teams should quarantine inventory and review potentially affected procedures.

Rayan Salih · 6 min read

Sealed catheter introducer kits and an Impella supply checklist in a cardiac procedure room

Innovation & Devices

Impella Introducer Recall Requires Kit-Level Checks

The FDA’s Class I classification covers certain catheter introducers in kits used with Impella heart pumps. Heart teams should verify identifiers and incorporate the manufacturer’s correction into procedural checks.

Rayan Salih · 6 min read

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