Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases

Shots: Natera has reported the commercial launch of Zenith genomics, a next-generation whole genome sequencing (WGS) assay designed to enhance the detection of rare diseases in the US The platform combines whole genome sequencing with long-read sequencing confirmation to detect genomic features such as tandem repeat expansions, supporting diagnosis of rare & ultra-rare conditions, &…

ByRidhi RastogiMarch 13, 2026

NEWS

C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea

Shots: C2N Diagnostics has entered into an agreement with BeauBrain Healthcare to offer PrecivityAD2 blood test for use in pts (≥50yrs.) with signs or symptoms of mild cognitive impairment or dementia in South Korea Study in The JAMA showed PrecivityAD2 improved diagnostic accuracy of Alzheimer’s disease vs SoC, while research in npj Dementia showed that the test demonstrated 91%…

ByRidhi RastogiMarch 12, 2026

NEWS

Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy

Shots: The US FDA has received a De Novo 510(k) application for the Breast Cancer Locator (BCL) System to improve the accuracy of breast-conserving surgery (lumpectomy) Cairn Surgical completed its US pivotal trial of the system, with data to be presented at the ASBrS’26 & incl. in the FDA filing, along with earlier data, published…

ByRidhi RastogiMarch 12, 2026

NEWS

QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

Shots: The US FDA has cleared all QIAstat-Dx GI Panels for use on the QIAstat-Dx Rise automated syndromic testing system The clearance enables laboratories to run both GI and respiratory panels on the high-throughput platform, which can process up to 160 tests/day, run 16 samples per batch, and deliver results in ~1hr. using real-time PCR…

ByRidhi RastogiMarch 11, 2026

NEWS

Medtronic to Acquire Scientia Vascular for $550M

Shots: Medtronic has entered into a definitive agreement to acquire Scientia Vascular, expanding its neurovascular device portfolio As per the deal, Medtronic will acquire Scientia Vascular for $550M, with potential undisclosed earn-out & milestone payments post-acquisition Acquisition will integrate Scientia’s access platform with Medtronic’s neurovascular therapies to support the full procedural workflow for hemorrhagic &…

ByRidhi RastogiMarch 11, 2026

NEWS

Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation

Shots: Pulse Biosciences has reported clinical data from the ablation study (n=21), an extension of the initial feasibility study, to assess the outcome durability of the nPulse Vybrance Percutaneous Electrode System for benign thyroid nodules Long-term follow-up showed durable efficacy with ~74% average volume reduction in treated benign thyroid nodules at 15-22mos., continued reduction was…

ByRidhi RastogiMarch 10, 2026

NEWS

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

NEWS

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

NEWS

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

NEWS

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

Natera Launches Zenith Genomics in the US to Diagnose Rare Diseases

C2N Diagnostics Partners with BeauBrain Healthcare to Offer PrecivityAD2 Blood Test for Alzheimer’s Disease in South Korea

Cairn Surgical Reports the FDA De Novo 510(k) Submission for BCL System to Improve Accuracy of Lumpectomy

QIAGEN Wins the US FDA Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise Syndromic Testing System

Medtronic to Acquire Scientia Vascular for $550M

Pulse Biosciences Reports Clinical Data on nPulse Vybrance System for Benign Thyroid Nodule Ablation

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

Contact US

FOLLOW US