Archive

Tyto Stethoscope (G3) — Tyto Care , Ltd. (FDA K252089)

Lets you capture and share heart sounds remotely, supporting tele-consultations and follow-ups without an in-person visit.

Cardiology · FDA — AI/ML-Enabled Medical Devices · 12 Mar

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) — Canon Medical Systems Corporation (FDA K253584)

Expanded field-of-view on Canon fluoroscopy reduces need for manual repositioning during long interventions, saving time and radiation exposure.

Radiology · FDA — AI/ML-Enabled Medical Devices · 10 Mar

LiverMultiScan (v6.0) — Perspectum, Ltd. (FDA K253413)

Adds an FDA-cleared MRI tool to quantify liver fat and fibrosis non-invasively, potentially reducing biopsy need in NAFLD patients.

Radiology · FDA — AI/ML-Enabled Medical Devices · 9 Mar

Onera SleepMap (SLEEPMAP) — Onera B.V. (FDA K253668)

FDA-cleared AI sleep monitor may offer home-based assessment, potentially reducing need for in-lab polysomnography in select patients.

Neurology · FDA — AI/ML-Enabled Medical Devices · 8 Mar

Mazor X System / Mazor X Stealth Edition — Mazor Robotics Ltd. (FDA K251316)

Spine surgeons can now use this cleared navigation platform to improve screw placement accuracy and reduce revision rates in complex procedures.

Neurology · FDA — AI/ML-Enabled Medical Devices · 11 Sept

Proton’s device aims to help those with kidney disease and cut heart-failure risks

A wearable potassium monitor could let you catch life-threatening imbalances early in CKD or heart-failure patients, shifting care from crisis to prevention.

Medicine · TechCrunch — Health · 24 Dec

YouTube is making it easier to find accurate information about first aid and emergency care

When patients search for emergency steps, they'll now see vetted videos from credible sources, reducing reliance on unverified clips that could mislead care.

General Medicine · TechCrunch — Health · 10 Jan

Withings’ new multiscope device checks vitals for telehealth visits

Enables patients to capture ECG, heart sounds, and more at home, making telehealth assessments more reliable for remote consultations.

General Medicine · TechCrunch — Health · 8 Jan

Google unveils MedLM, a family of healthcare-focused generative AI models

MedLM may soon assist you with clinical documentation and decision support, but evidence of real-world benefit is still pending.

Medicine · TechCrunch — Health · 13 Dec