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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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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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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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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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Natera Seeks PMDA Approval for Signatera CDx in MIBC

Shots: Natera has submitted an application to Japan's PMDA seeking approval of Signatera as a companion diagnostic (CDx) for muscle-invasive bladder cancer (MIBC) The submission expands the company's presence in Japan, where Signatera became the country's first PMDA-approved molecular residual disease (MRD) test for colorectal cancer in Jun 2026 Application is supported by data from…
August 5, 2026

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Sight Sciences’ OMNI Ultra Surgical System Secures the US FDA 510(k) Clearance

Shots: The US FDA has granted 510(k) clearance to the OMNI Ultra Surgical System for canaloplasty followed by trabeculotomy for the reduction of intraocular pressure (IOP) in adults with primary open-angle glaucoma (POAG) The OMNI platform is backed by extensive clinical evidence showing sustained IOP reduction and reduced medication use, with the OMNI Ultra remaining on…
August 5, 2026

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KKR to Acquire Integer for ~$5.7B

Shots: Integer and KKR have entered into a definitive agreement under which an affiliate of investment funds managed by KKR will acquire Integer, delisting it from NYSE As per the deal, KKR will acquire Integer in an all-cash transaction valued at $127 per share, representing the total enterprise value of ~$5.7B As a KKR portfolio…
August 5, 2026

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