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…

ByRidhi Rastogi2 hours ago

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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…

ByRidhi Rastogi3 hours ago

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Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

Shots: Co-Diagnostics submitted a Dual FDA 510(k) premarket notification with a concurrent CLIA Waiver application for its Co-Dx PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro platform Submission was backed by clinical & analytical performance studies, incl. study of over 1,400 symptomatic pts across 9 US sites, & 27…

ByRidhi Rastogi4 days ago

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BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Shots: The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26 Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…

ByRidhi RastogiAugust 6, 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…

ByRidhi RastogiAugust 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…

ByRidhi RastogiAugust 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…

ByRidhi RastogiAugust 5, 2026

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Galaxy Therapeutics Secures CE Mark for SEAL Embolization System

Shots: Galaxy has received CE Mark under the EU MDR 2017/745 for its SEAL Embolization System, following assessment by Notified Body DQS Medizinprodukte. Launch expected across selected EU markets, with FDA’s PMA application underway The SEAL Embolization System is an intrasaccular device for endovascular treatment of ruptured & unruptured wide-neck intracranial aneurysms, supporting aneurysm sizes…

ByRidhi RastogiAugust 4, 2026

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Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal

Shots: Invenio has completed patient enrollment in the ON-SITE study evaluating NIO Lung Cancer Reveal, an AI-based image analysis module for rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO Imaging System The study enrolled 1,006 pts, involving >3,250 fresh biopsy specimens across 7 US medical centers, with specimens collected using transbronchial forceps biopsy,…

ByRidhi RastogiAugust 3, 2026

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NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US

Shots: NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026 ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The…

ByPrince GiriJuly 31, 2026

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

Teledyne to Acquire Varex Imaging for $1.1B

Co-Diagnostics Submits FDA 510(k) and CLIA Waiver Applications for Point-of-Care PCR Flu A/B & RSV Test

BlueWind Medical Receives FDA Clearance for Revi Extend Implant

Natera Seeks PMDA Approval for Signatera CDx in MIBC

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

KKR to Acquire Integer for ~$5.7B

Galaxy Therapeutics Secures CE Mark for SEAL Embolization System

Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal

NIPRO Receives FDA 510(k) Clearance for ELISIO-HX Dialyzer for Expanded Hemodialysis in the US

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