FDA Cleared Patient Monitoring

FDA clears Masimo device for ventilated patients

Released on August 14, 2020

Masimo (NSDQ:MASI) announced today that it received FDA clearance for its PVi for fluid responsiveness indication in ventilated adult patients. PVi (pleth […]

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Diagnostics FDA Cleared Oncology

Guardant companion diagnostic gets FDA nod as 1st liquid biopsy with NGS

Released on August 10, 2020

Dive Brief: FDA Friday approved Guardant Health’s liquid biopsy diagnostic that uses next-generation sequencing (NGS) to identify patients with mutations of […]

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FDA Cleared Implantables Orthopedic

FDA clears LifeSpine anterior lumbar spacer system

Released on August 7, 2020

Spinal disorder treatment developer Life Spine announced that it received FDA clearance for its Plateau-A Ti anterior lumbar spacer system. Huntley, Ill.-based Life […]

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Digital Health FDA Cleared Wearables

Samsung says it has received FDA clearance for smartwatch ECG tracking

Released on August 6, 2020

Alongside yesterday’s reveal of the Galaxy Watch3, Samsung announced that it has received regulatory clearance from the FDA for its ECG […]

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FDA Cleared Imaging Radiology

FDA clears SOMATOM On.site from Siemens Healthineers for CT exams at the bedside

Released on August 6, 2020

The US Food and Drug Administration (FDA) has cleared the SOMATOM On.site, a mobile head computed tomography (CT) scanner from Siemens […]

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FDA Cleared Robotics Surgery

Yomi robotic system from Neocis gets FDA approval for full-arch dental implants

Released on July 29, 2020

Neocis Inc. today said that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Yomi system […]

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AI FDA Cleared Radiology

Zebra Medical Vision receives 510(k) clearance for AI mammogram tool

Released on July 28, 2020

Zebra Medical Vision has announced its latest Food and Drug Administration 510(k) clearance for HealthMammo, an artificial intelligence tool that helps […]

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AI FDA Cleared Imaging

FDA clears Canon Medical AI-based image reconstruction tech

Released on July 22, 2020

Canon Medical (NYSE:CAJ) announced today that it received FDA 510(k) clearance for its advanced intelligent clear-IQ engine (AiCE). Tustin, Calif.-based Canon Medical’s […]

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FDA Cleared Patient Monitoring Wearables

LifeSignals wireless biosensor wins FDA clearance

Released on July 21, 2020

LifeSignals Group announced today that it received FDA 510(k) clearance for its LifeSignals ECG remote monitoring patch platform. Fremont, Calif.-based LifeSignals develops […]

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FDA Cleared Implantables Orthopedic

FX Shoulder gets FDA nod for coated shoulder implants

Released on July 20, 2020

FX Shoulder USA announced today that the FDA issued 510(k) clearance for a new version of its humeral head and glenosphere […]

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FDA Cleared Imaging MedTech

Micro-X mobile X-ray system FDA cleared

Released on July 20, 2020

Micro-X announced today that its Rover mobile X-ray product designed for military medical facilities received FDA 510(k) clearance. Adelaide, Australia-based Micro-X said […]

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FDA Cleared Patient Monitoring Wearables

Vitls Platform Cleared in U.S. for Remote Patient Monitoring

Released on July 20, 2020

Vitls Inc., a company out of Houston, Texas, won FDA clearance for its Vitls Platform, a combination of a vitals monitoring […]

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