LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

Shots: Approval for adults with mod. to sev. OSA (AHI: 15–65) who failed, cannot tolerate, or are ineligible for 1L therapies, was backed by OSPREY RCT, which met its 1EPs at 6mos. (M6) vs control, showing reductions in AHI, ODI, & improved PROs in sleep disturbance In the RCT (therapy start: M1 vs M7), M12…

ByRidhi Rastogi2 days ago

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JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…

ByRidhi Rastogi3 days ago

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Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Shots: The US FDA has granted 510(k) clearance to the Urocross Expander System for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), backed by extensive data incl. the Expander-1 & Expander-2 trials Expander-2 (n=240) showed mean 48.1% IPSS improvement & a 74.5% responder rate (≥30% IPSS reduction) at 12mos. post implantation…

ByRidhi RastogiMarch 17, 2026

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Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Shots: Roche has received the CE Mark approval for its Elecsys Apolipoprotein E4 biomarker test, an in-vitro diagnostic immunoassay to identify the presence of the ApoE4 gene variant in the bloodstream The assay was evaluated in a study of 607 subjects with cognitive complaints or objective memory impairment of unknown aetiology, where Elecsys ApoE4 assay showed…

ByRidhi RastogiMarch 16, 2026

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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

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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

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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

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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

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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

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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

LivaNova’s aura6000 System Secures the US FDA Premarket Approval to Treat Obstructive Sleep Apnea (OSA)

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Prodeon Medical Secures FDA Clearance for Urocross Expander System to Treat Urinary Symptoms Associated with BPH

Roche Receives CE Mark for its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

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

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