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Roche
NEWS

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…
August 24, 2026

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NEWS

Masimo Secures CE Mark for smartSedLine to Advance Anesthetic Management

Shots: Masimo has received CE Mark approval for smartSedLine, a brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to provide greater responsiveness to brain activity & improved stability during anesthesia smartSedLine continuously displays four real-time bilateral frontal EEG waveforms & key parameters, incl. the 0–100 PSi reflecting sedation level, supporting more…
August 19, 2026

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NEWS

Vesalio Receives FDA 510(k) Clearance for pVasc NET Peripheral Thrombectomy Device

Shots: Vesalio has received the US FDA 510(k) clearance for pVasc NET, a next-generation peripheral mechanical thrombectomy device with an integrated distal filter  pVasc NET builds on the pVasc platform, a self-expanding nitinol device delivered through a low-profile catheter for non-surgical removal of emboli & thrombi from peripheral blood vessels pVasc NET features a fine-pore,…
August 14, 2026

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NEWS

Freenome’s SimpleScreen Lung Cancer Screening Test Secures Breakthrough Device Designation

Shots: The US FDA has granted Breakthrough Device Designation to SimpleScreen Lung to detect early signals of lung cancer in a blood sample from a standard blood draw SimpleScreen Lung builds on its base-level methylation & next-generation sequencing platform, combining methylation & proteomics with an AI/ML-powered classifier to detect lung cancer signals Freenome presented initial…
August 13, 2026

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NEWS

Elevation Spine Receives FDA Clearance for Saber-XA ALIF System

Shots: The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…
August 12, 2026

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Bracco
NEWS

Bracco Imaging Secures FDA and Health Canada Clearances for VueJect

Shots: Bracco Imaging has received the US FDA 510(k) clearance & Health Canada authorization for VueJect, its dedicated ultrasound contrast delivery system designed specifically for cardiology imaging VueJect is designed to improve workflow efficiency, reduce operator variability & enable continuous administration of ultrasound contrast agents for more consistent enhancement during cardiac imaging VueJect will initially…
August 12, 2026

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NEWS

Ceribell Secures FDA Clearance for AI-Powered EEG Enhancements

Shots: The US FDA has granted 510(k) clearance to two AI algorithm enhancements, Epileptiform Abnormality Detection & Artifact Reduction, which are integrated into its cloud-based Neurology Portal The Artifact Reduction algorithm identifies interference from patient movement, medical equipment, and physiological signals, while Epileptiform Abnormality Detection flags abnormal patterns across lengthy EEG recordings, helping neurologists navigate…
August 11, 2026

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NEWS

Revvity Debuts SuperFlex Prenatal Screening System

Shots: Revvity has launched SuperFlex, a compact immunoassay platform for rapid, reliable prenatal screening in lower-volume laboratories & clinics, incl. preeclampsia testing SuperFlex offers an affordable, low-waste setup with annual maintenance, simplified operation and minimal training, plus flexible throughput with continuous loading and results in as little as 14min SuperFlex supports first & second-trimester biochemical…
August 11, 2026

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QIAGEN Reports the US FDA Clearance of QIAstat-Dx BCID GPF Plus AMR Panel for Bloodstream Infection Syndromic Testing

Shots: The US FDA has granted clearance to QIAstat-Dx BCID GPF Plus AMR Panel for bloodstream infection testing  The panel identifies 20 gram-positive bacterial & fungal pathogen targets & 10 antimicrobial resistance markers, delivering results in ~1 hour to support rapid clinical decision-making & antimicrobial stewardship Clearance supports QIAGEN’s expansion of its US bloodstream infection…
August 11, 2026

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NEWS

Teledyne to Acquire Varex Imaging for $1.1B

Shots: Teledyne Technologies agreed to acquire Varex Imaging for $18.90 per share in cash, valuing the transaction at approximately $1.1B, incl. Varex’s equity awards & net debt Varex develops X-ray tubes, flat-panel & photon-counting detectors, high-voltage interconnects & imaging software used across medical imaging, oncology, industrial inspection, security & vehicle inspection The acquisition is expected…
August 11, 2026

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