Medical Device Developments Weekly

Medical Device Developments Weekly

Welcome to this week's Medical Device Developments newsletter.

See the latest insight and analysis from the global medical device market from the last week below:


Biosense Webster receives CE mark for Varipulse PFA Platform

The Varipulse Platform, which comprises the Varipulse Catheter, Trupulse Generator, and Carto 3 System, is intended to treat symptomatic drug refractory recurrent paroxysmal AF.  Varipulse Catheter is a variable-loop multielectrode catheter, Trupulse Generator is a multichannel PFA generator and Carto 3 System is a 3D cardiac mapping system.  According to Biosense Webster, the Varipulse Platform is the first and only Carto-integrated PFA system that enables reproducible workflow with real-time visualisation and feedback set-up.

The Varipulse Platform, which comprises the Varipulse Catheter, Trupulse Generator, and Carto 3 System, is intended to treat symptomatic drug refractory recurrent paroxysmal AF.

Varipulse Catheter is a variable-loop multielectrode catheter, Trupulse Generator is a multichannel PFA generator and Carto 3 System is a 3D cardiac mapping system.

According to Biosense Webster, the Varipulse Platform is the first and only Carto-integrated PFA system that enables reproducible workflow with real-time visualisation and feedback set-up.

Read more


Empatica officially launches wearable epilepsy monitoring watch EpiMonitor

EpiMonitor is said to be an all-in-one epilepsy monitoring solution that provides patients and doctors with continuous, accurate health insights.  It also detects and alerts for seizures using Empatica’s next-generation medical watch, EmbracePlus, and a companion smartphone app.  The product has been cleared by the US Food and Drug Administration (FDA) for use in adult and children populations aged six and more.  EpiMonitor is now said to be the only commercially available wearable solution with regulatory approval for seizure detection in the US.

EpiMonitor is said to be an all-in-one epilepsy monitoring solution that provides patients and doctors with continuous, accurate health insights.

It also detects and alerts for seizures using Empatica’s next-generation medical watch, EmbracePlus, and a companion smartphone app.

The product has been cleared by the US Food and Drug Administration (FDA) for use in adult and children populations aged six and more.

EpiMonitor is now said to be the only commercially available wearable solution with regulatory approval for seizure detection in the US.

Read more


BD recruits first patient in AGILITY trial of BD Vascular Covered Stent

The BD Vascular Covered Stent, which is under investigation, is a low-profile, self-expanding nitinol implant enclosed in polytetrafluoroethylene.  It is administered using a delivery mechanism that allows for regulated stent release.  The global, prospective, multi-centre, single-arm, non-randomised AGILITY intends to study the safety and effectiveness of the vascular-covered stent in the treatment of peripheral arterial disease (PAD).  The trial will recruit 315 patients at up to 40 clinical study sites across the US, Europe, Australia and New Zealand.Every treated patient will have follow-up at different intervals following therapy, ranging from one month to three years.

The BD Vascular Covered Stent, which is under investigation, is a low-profile, self-expanding nitinol implant enclosed in polytetrafluoroethylene.

It is administered using a delivery mechanism that allows for regulated stent release.

The global, prospective, multi-centre, single-arm, non-randomised AGILITY intends to study the safety and effectiveness of the vascular-covered stent in the treatment of peripheral arterial disease (PAD).

The trial will recruit 315 patients at up to 40 clinical study sites across the US, Europe, Australia and New Zealand.Every treated patient will have follow-up at different intervals following therapy, ranging from one month to three years.

Read more


Philips unveils new Azurion system for neurovascular procedures

The company has designed the new Azurion neuro biplane system to streamline neurovascular procedures and aid care teams in making fast and right decisions.  The interventional system, which has enhanced 2D and 3D imaging and X-ray detector positioning flexibility, also allows the treatment of more patients and achieves better outcomes.  The Dutch health technology company claims that the new Azurion neuro biplane system improves the experience of both staff and patients while lowering the costs of care.  Philips’ new interventional system is intended to optimise and improve procedure workflows in situations where a precise diagnosis and treatment plan require a combination of 2D and 3D imaging.  It uses the health technology firm’s latest Neuro Suite software and services to offer neuro-interventionists a fully integrated solution.

The company has designed the new Azurion neuro biplane system to streamline neurovascular procedures and aid care teams in making fast and right decisions.

The interventional system, which has enhanced 2D and 3D imaging and X-ray detector positioning flexibility, also allows the treatment of more patients and achieves better outcomes.

The Dutch health technology company claims that the new Azurion neuro biplane system improves the experience of both staff and patients while lowering the costs of care.

Philips’ new interventional system is intended to optimise and improve procedure workflows in situations where a precise diagnosis and treatment plan require a combination of 2D and 3D imaging.

It uses the health technology firm’s latest Neuro Suite software and services to offer neuro-interventionists a fully integrated solution.

Read more


Know Labs, Inc. unveils new wearable non-invasive CGM system KnowU

KnowU is designed based on Know Labs, Inc.’ unique technology that incorporates a unique radiofrequency (RF) sensor, which has proven to be stable and accurate in lab tests.  The sensor measures glucose levels using dielectric spectroscopy by quickly scanning a wide range of RF frequencies.  It records voltage values detected at each frequency to quantify, with advanced machine learning algorithms, real-time continuous blood glucose levels.  KnowU exploits the dielectric properties of glucose, including its ability to store electrical energy in an electrical field, as measured through a voltage reading received after each frequency.

KnowU is designed based on Know Labs, Inc.’ unique technology that incorporates a unique radiofrequency (RF) sensor, which has proven to be stable and accurate in lab tests.

The sensor measures glucose levels using dielectric spectroscopy by quickly scanning a wide range of RF frequencies.

It records voltage values detected at each frequency to quantify, with advanced machine learning algorithms, real-time continuous blood glucose levels.

KnowU exploits the dielectric properties of glucose, including its ability to store electrical energy in an electrical field, as measured through a voltage reading received after each frequency.

Read more


Philips introduces Philips CT 5300 for interventional procedures

The Philips CT 5300 system is said to be an adaptable X-ray CT system. It is designed to enhance patient outcomes and department productivity by streamlining workflow, optimising system up-time, and boosting diagnostic confidence.  According to the Dutch health technology firm, the X-ray CT system meets advanced diagnostic imaging standards for cardiac care patient guidelines and difficult areas including trauma care and interventional treatments.  Additionally, the system incorporates virtual tools for clinical/technical assistance and real-time communication.

The Philips CT 5300 system is said to be an adaptable X-ray CT system. It is designed to enhance patient outcomes and department productivity by streamlining workflow, optimising system up-time, and boosting diagnostic confidence.

According to the Dutch health technology firm, the X-ray CT system meets advanced diagnostic imaging standards for cardiac care patient guidelines and difficult areas including trauma care and interventional treatments.

Additionally, the system incorporates virtual tools for clinical/technical assistance and real-time communication.

Read more


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