Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Shots: The US FDA has granted IDE approval to initiate the NANOPULSE-AF study of Pulse's nsPFA Cardiac Catheter System for the treatment of PAF The study will assess the primary safety and efficacy of the nsPFA Cardiac Catheter System in ~145 pts for the treatment of drug-resistant symptomatic PAF across 30 sites, incl. 3 outside…

ByRidhi RastogiDecember 19, 2025

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Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Shots: Aqua Medical has received the US FDA IDE approval to initiate the RESTORE-1 study evaluating the Proximal Intestinal Mucosal Ablation (PIMA) procedure using its radiofrequency vapor ablation (RFVA) system in adults with uncontrolled type 2 diabetes The IDE approval was backed by international data showing safety & metabolic benefits of PIMA, allowing Aqua Medical…

ByRidhi RastogiNovember 6, 2025

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Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Shots: The US FDA has granted BDD to Avvio ELS for minimally invasive, anesthesia-independent kidney stone treatment AVVIO ELS will be investigated in a pivotal ELS trial across the US following IDE approval, with US commercial launch planned in 2026, pending FDA clearance The AVVIO ELS uses microbubble-enhanced acoustic cavitation lithotripsy to enable minimally invasive kidney…

ByRidhi RastogiOctober 29, 2025

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Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

Shots: Airiver Medical has received the US FDA’s IDE approval to initiate trial for Airiver Pulmonary Drug Coated Balloon (DCB) for the treatment of central airway stenosis The study will assess safety & efficacy of Airiver Pulmonary DCB against SoC bare balloon dilation in ~200 pts with central airway stenosis & support the US FDA…

ByRidhi RastogiAugust 28, 2025

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TransMedics Receives FDA Conditional IDE Approval to Initiate OCS ENHANCE Heart Study

Shots: TransMedics received US FDA conditional IDE approval to initiate its two-part Next‑Gen OCS ENHANCE Heart study evaluating prolonged heart perfusion (Part A) and superiority of OCS Heart in donation after brain death (DBD) cases vs static cold storage (Part B) The study will enroll >650 pts; Part B aims to expand OCS Heart indications…

ByPrince GiriAugust 6, 2025

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ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

Shots: ReGelTec has received European MDR CE Mark approval for its Class III HYDRAFIL System, a disc augmentation therapy designed to reduce pain, improve daily function & eliminate the need for invasive surgeries Approval was based on a study of 75 pts showing over 80% improvement in Oswestry Disability Index (ODI) scores & >70% pain…

ByRidhi RastogiMay 22, 2025

Pulse Biosciences Receives the US FDA IDE Approval to Initiate Study for nsPFA System in Paroxysmal Atrial Fibrillation (PAF)

Aqua Medical Receives the US FDA IDE Approval to Initiate Trial for Ablation Procedure to Treat Uncontrolled Type 2 Diabetes

Avvio Medical’s Avvio Enhanced Lithotripsy System (ELS) Receives the US FDA’s Breakthrough Device Designation (BDD) for Kidney Stone Treatment

Airiver Medical Receives the US FDA’s IDE Approval to Study Airiver Pulmonary Drug Coated Balloon for Benign Central Airway Stenosis

TransMedics Receives FDA Conditional IDE Approval to Initiate OCS ENHANCE Heart Study

ReGelTec’s HYDRAFIL System Gains European CE Mark Approval for Chronic Low Back Pain

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