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Personalis
NEWS

Tempus AI to Acquire Personalis for ~$1.5B

Shots: Tempus AI has entered into a definitive agreement to acquire Personalis, expanding Tempus' capabilities in minimal residual disease (MRD) As per the deal, Personalis shareholders will receive $16.25 per share, valuing the company at an enterprise value of $1.5B, net of Tempus AI’s existing ownership interest; closing expected in late 2026 or early 2027…
19 hours ago

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HoneyNaps Secures FDA Clearance for AI Sleep Diagnostic Software Somnum V3.0

Shots: The US FDA has granted 510(k) clearance to Somnum V3.0, an AI-based clinical decision support software to assist medical professionals in analyzing polysomnography data, incl. sleep staging & respiratory event detection Somnum V3.0 automatically detects apnea & hypopnea events, & classifies them as obstructive, central, or mixed sleep apnea. Validation data submitted to the…
July 16, 2026

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SpinaFX Medical Secures CE Mark MDR Approval for Triojection System

Shots: SpinaFX has received MDR CE Mark for its Triojection System, which delivers a controlled ozone-oxygen gas mixture for procedures. Triojection also received US FDA’ IDE approval in Jun 2026 SpinaFX is engaging distribution partners to launch Triojection in priority markets, initially targeting pts with persistent pain from contained herniated discs who have failed conservative…
July 16, 2026

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ElectroWire Medical Secures FDA 510(k) Clearance for LightningWire Transseptal System

Shots: The US FDA has granted 510(k) clearance to the LightningWire Transseptal Puncture System, indicated to create an atrial septal defect to enable the introduction of cardiovascular catheters LightningWire combines an electrosurgical guidewire & activation cable for transseptal access, working with preferred introducers & existing electrosurgical generators. Its insulation enables low-power puncture, while the 0.032-inch…
July 16, 2026

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NEWS

HistoSonics Reports CE Mark Approval of Edison System for Unresectable Liver Tumors

Shots: HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…
July 14, 2026

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NEWS

Viz.ai Partners with Cortechs.ai to Expand AI Platform into Neurodegenerative Disease Care

Shots: Viz.ai has partnered with Cortechs.ai to integrate its NeuroQuant & NeuroQuant MS into its AI-powered care coordination platform, expanding into neurodegenerative diseases The collaboration will initially focus on multiple sclerosis by integrating Cortechs.ai’s quantitative MRI analysis into Viz.ai’s clinical workflow & care coordination platform to improve MS identification, characterization, & management The company plans…
July 10, 2026

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Roche
NEWS

Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…
July 9, 2026

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iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…
July 9, 2026

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NEWS

Longeviti Launches ClearFit AI Platform for Bedside Brain Ultrasound Access

Shots: Longeviti Neuro has launched ClearFit AI, a Brain Ultrasound Interface, creating a persistent acoustic window to the brain to enable real-time bedside ultrasound imaging after neurosurgery ClearFit AI combines sonolucent cranial implants, ultrasound compatibility, clinical workflow support, & AI-enhanced imaging to enable bedside brain assessment within existing neuro care workflows, potentially reducing CT/MRI transport…
July 8, 2026

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