Harrison.ai Secures the US FDA 510(k) Clearance for Acute Infarct Triage on Non-Contrast CT Brain

Shots: The US FDA has granted 510(k) clearance to Harrison.ai’s acute infarct triage for non-contrast CT brain scans 510(k) submission compared infarct triage with existing stroke AI tools, incl. an FDA-cleared LVO device on non-contrast CT showing 63.5% sensitivity & 95.1% specificity for vessel occlusion detection only, plus CTA-based LVO systems that require contrast…

ByRidhi RastogiMarch 6, 2026

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Airiver Medical Receives FDA Breakthrough Device Designation for Airiver DCB and Treats First Patient with Central Airway Stenosis

Shots: The US FDA has granted BDD to Airiver Pulmonary Drug Coated Balloon (DCB) to treat central airway stenosis Additionally, the first patient has been enrolled & treated in a trial evaluating the Airiver DCB vs SoC bare balloon dilation in ~200 pts with central airway stenosis; positive results could support a future FDA regulatory…

ByRidhi RastogiMarch 5, 2026

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Cara Medical Reports 510(k) clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

Shots: The US FDA has granted 510(k) clearance to CARA System for non-invasive, patient-specific 3D visualization of the cardiac conduction system, with commercialization to begin in the coming mos. The CARA System combines the CARA MetisTM Simulator, a preprocedural CTA-based simulator to create a personalized 3D map of the cardiac conduction system, with the CARA…

ByRidhi RastogiFebruary 26, 2026

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Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal

Shots: Sebela Pharmaceuticals has entered into an agreement granting Organon exclusive global rights to Miudella, a hormone-free copper intrauterine device (IUD) contraceptive As per the deal, Sebela will receive $27.5M at closing & ~$505M in sales-based milestone payments, with tiered net sales-based double-digit royalties Miudella was approved by the US FDA in Feb 2025, for…

ByRidhi RastogiFebruary 24, 2026

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Bio-Techne’s Ella Platform Receives the CE-IVD Marking for Rapid, Cartridge‑Based Immunoassays

Shots: Bio-Techne has received the European CE-IVD Mark for Ella benchtop immunoassay platform to produce accurate biomarker results in clinical settings Ella is compatible with Simple Plex assays powered by R&D Systems antibodies & proteins, offering over 390 analytes across neuroscience, immunology, oncology, & cell & gene therapy to ensure consistent, high-quality data across diverse research applications…

ByRidhi RastogiFebruary 17, 2026

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VB Spine to Acquire Exclusive Rights to xvision Spine System from Augmedics

Shots: VB Spine has entered into a definitive agreement with Augmedics to secure exclusive rights to the xvision Spine System, enhancing precision in open, minimally invasive, & percutaneous spine procedures through advanced augmented reality (AR) navigation tech Acquisition will expand VB Spine’s enhanced visualization portfolio by adding AR navigation capabilities, &, subject to regulatory approvals…

ByRidhi RastogiFebruary 17, 2026

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LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shots: The US FDA has granted 510(k) clearance & CLIA waiver to VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 respiratory season, with US commercial activities anticipated in 2026 VELO system allows multiplex PCR testing for respiratory…

ByRidhi RastogiFebruary 16, 2026

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EYE PCR’s fixOflex Receives CE Mark for Posterior Capsule Opacification, Advancing Cataract Surgery Innovation

Shots: EYE PCR has received the CE Mark under EU MDR for fixOflex endocapsular device for use during cataract surgery fixOflex has shown comparable safety to standard cataract surgery in a study of 121 pts, with 0.83% PCO incidence at 12mos. vs 13% in a retrospective control group, & no Nd:YAG capsulotomies required compared to…

ByRidhi RastogiFebruary 13, 2026

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Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Shots: The US FDA has granted 510(k) clearance to Encora X1 to help relieve hand tremors in the treated limb during stimulation in adults with essential tremor Clearance was backed by a sham-controlled trial & a 90-day home-use study, both demonstrating improvements in tremor severity & functional tasks, supporting the device’s ability to assist with…

ByRidhi RastogiFebruary 13, 2026

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Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…

ByRidhi RastogiFebruary 12, 2026

Harrison.ai Secures the US FDA 510(k) Clearance for Acute Infarct Triage on Non-Contrast CT Brain

Airiver Medical Receives FDA Breakthrough Device Designation for Airiver DCB and Treats First Patient with Central Airway Stenosis

Cara Medical Reports 510(k) clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

Sebela Pharmaceuticals Licenses Miudella to Organon in ~$532M Deal

Bio-Techne’s Ella Platform Receives the CE-IVD Marking for Rapid, Cartridge‑Based Immunoassays

VB Spine to Acquire Exclusive Rights to xvision Spine System from Augmedics

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

EYE PCR’s fixOflex Receives CE Mark for Posterior Capsule Opacification, Advancing Cataract Surgery Innovation

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

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