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News We’re Watching: Boston Scientific Updates PFA Progress, Novel Vibrating Pill For Obesity, And More

 
• By Reed Miller

Medtech Insight's News We're Watching highlights medtech industry developments that you may have missed over the last few weeks. The first edition for 2024 includes an update on Boston Scientific's pulsed field ablation technology and a preclinical trial of a novel weight-loss "pill." Also, Strkyer is acquiring SERF, Imperative Care is testing a new intracranial stent, and CardioMech closed a $13m funding round to support its artificial mitral chord repair technology.

Industry News We're Watching
• Source: Shutterstock

Boston Scientific is sponsoring AVANT GUARD, the first randomized trial of pulsed field ablation (PFA) as a first-line treatment for persistent atrial fibrillation (AF), the company announced at the end of 2023.

The trial will randomize more than 500 patients with persistent atrial fibrillation into two groups. The treatment group will undergo pulmonary vein isolation and left atrial posterior wall ablation with...

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• By Natasha Barrow

TRiCares presented data from the first-in-human study for its tricuspid valve replacement system – Topaz – at EuroPCR 2025 on 22 May.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
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A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.

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News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

News We’re Watching: New OPEQ Head, Constructive Bio Funding Round, Natera Wins Injunction In Patent Suit

 
• By Natasha Barrow, Brian Bossetta, Elizabeth Orr, and Marion Webb

This week, the FDA announced a new head of its device evaluation office; synthetic genomics firm Constructive Bio landed $58m in funding; and Natera got a permanent injuction against NeoGenomics Labs' RaDaR assay.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

 
• By Marion Webb, Brian Bossetta, Elizabeth Orr, and Natasha Barrow

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.