Medical Device Developments Weekly: 08/11/23

Medical Device Developments Weekly: 08/11/23

The latest insight and analysis from the global medical device market from the last week courtesy of Medical Device Developments


DuPont collaborates with STMicroelectronics (ST) to develop new smart wearable device concept for monitoring biosignals

“Dedicated Liveo research teams collaborate with suppliers and manufacturers worldwide to create solutions across a vast array of medical applications – including smart devices that can share data between patients and doctors,” said DuPont Liveo Global Business Leader EUGENIO TOCCALINO. “The wearable device concept that resulted from the collaboration between DuPont and ST is the DuPont Liveo Smart Biosensing Patch prototype, which employs multifunctional microsensors and control electronics from STMicroelectronics embedded in a flexible patch design from DuPont.  ”By collaborating with others across the healthcare ecosystem – from technology developers and material suppliers to device fabricators and OEMs – DuPont is developing more patient-centric solutions that contribute to better patient outcomes.

“Dedicated Liveo research teams collaborate with suppliers and manufacturers worldwide to create solutions across a vast array of medical applications – including smart devices that can share data between patients and doctors,” said DuPont Liveo Global Business Leader EUGENIO TOCCALINO .

“The wearable device concept that resulted from the collaboration between DuPont and ST is the DuPont Liveo Smart Biosensing Patch prototype, which employs multifunctional microsensors and control electronics from STMicroelectronics embedded in a flexible patch design from DuPont .

”By collaborating with others across the healthcare ecosystem – from technology developers and material suppliers to device fabricators and OEMs – DuPont is developing more patient-centric solutions that contribute to better patient outcomes.

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Embolx, Inc. announces global distribution partnership with Girlow USA

The Sniper is Embolx, Inc.’s flagship product, intended to transform the embolic treatment procedures for various conditions.  It is designed to improve the delivery of embolic agents to treat different types of cancer and benign prostatic hyperplasia (BPH) while protecting the surrounding healthy tissues.  Under the partnership, Embolx, Inc. plans to use Girlow’s established distribution channels and network to make this advanced technology more easily accessible beyond the US and Europe. The collaboration will support healthcare workers and institutions across Mexico, Central America, South America, and the Caribbean to access Embolx, Inc.’s technologies.

The Sniper is Embolx, Inc. ’s flagship product, intended to transform the embolic treatment procedures for various conditions.

It is designed to improve the delivery of embolic agents to treat different types of cancer and benign prostatic hyperplasia (BPH) while protecting the surrounding healthy tissues.

Under the partnership, Embolx, Inc. plans to use Girlow’s established distribution channels and network to make this advanced technology more easily accessible beyond the US and Europe. The collaboration will support healthcare workers and institutions across Mexico, Central America, South America, and the Caribbean to access Embolx, Inc. ’s technologies.

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BD introduces PIVO Pro Needle-free Blood Collection Device for integrated catheters

Administration (FDA), includes design enhancements that make it the first and only option for use with integrated and extended peripheral IV catheters, said the company.  This compatibility extends to the new Nexiva Closed IV Catheter System with NearPort IV Access, building upon the existing PIVO compatibility with traditional short peripheral IV catheters established since 2017.  According to BD, the PIVO Pro Needle-free Blood Collection Device merges the clinical advantages demonstrated by the integrated closed Nexiva Catheter System.  These include extended dwell times and fewer catheter-related issues, with the capability to collect high-quality blood samples directly from a patient’s peripheral IV line using PIVO Pro.

The device, which has received 510(k) clearance from the US Food and Drug Administration (FDA), includes design enhancements that make it the first and only option for use with integrated and extended peripheral IV catheters, said the company.

This compatibility extends to the new Nexiva Closed IV Catheter System with NearPort IV Access, building upon the existing PIVO compatibility with traditional short peripheral IV catheters established since 2017.

According to BD , the PIVO Pro Needle-free Blood Collection Device merges the clinical advantages demonstrated by the integrated closed Nexiva Catheter System.

These include extended dwell times and fewer catheter-related issues, with the capability to collect high-quality blood samples directly from a patient’s peripheral IV line using PIVO Pro.

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SiBionics obtains CE Mark for GS1 continuous glucose monitoring system

According to SiBionics, the GS1 CGM System is intended to help healthcare professionals as well as patients with the information required for forming informed treatment decisions and for sustaining optimal glucose control.  The system provides users with a 14-day calibration-free continuous glucose monitoring solution, allowing them to transmit glucose data to their monitoring devices or mobile apps and generate professional AGP reports.  Besides, the GS1 CGM supports data sharing with friends and family and is said to seamlessly integrate the advanced ProView remote access platform.  This enables healthcare providers to monitor patients remotely and provide timely medical interventions when necessary, aiding in improved diabetes management, said the company.

According to SiBionics , the GS1 CGM System is intended to help healthcare professionals as well as patients with the information required for forming informed treatment decisions and for sustaining optimal glucose control.

The system provides users with a 14-day calibration-free continuous glucose monitoring solution, allowing them to transmit glucose data to their monitoring devices or mobile apps and generate professional AGP reports.

Besides, the GS1 CGM supports data sharing with friends and family and is said to seamlessly integrate the advanced ProView remote access platform.

This enables healthcare providers to monitor patients remotely and provide timely medical interventions when necessary, aiding in improved diabetes management, said the company.

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Ortho Development Corporation rolls out BKS Uni partial knee replacement system

BKS Uni is the latest product in the company’s portfolio of Balanced Knee implant systems.   The partial knee replacement system is designed to preserve bone, simplify surgical technique, and deliver the clinical benefits of the Balanced Knee System.  It provides surgeons with medial fixed-bearing implants and instruments to facilitate intraoperative adjustments for precise and balanced treatment of unicompartmental knee arthritis.  BKS Uni, when used together with other Ortho Development Corporation Balanced Knee Solutions, allows surgeons with a continuum of care to treat a wide array of knee pathologies. The integrated solution allows them to treat from partial knee replacements to advanced revision procedures, ensuring customised solutions for diverse patient needs.

BKS Uni is the latest product in the company’s portfolio of Balanced Knee implant systems.

The partial knee replacement system is designed to preserve bone, simplify surgical technique, and deliver the clinical benefits of the Balanced Knee System.

It provides surgeons with medial fixed-bearing implants and instruments to facilitate intraoperative adjustments for precise and balanced treatment of unicompartmental knee arthritis.

BKS Uni, when used together with other Ortho Development Corporation Balanced Knee Solutions, allows surgeons with a continuum of care to treat a wide array of knee pathologies. The integrated solution allows them to treat from partial knee replacements to advanced revision procedures, ensuring customised solutions for diverse patient needs.

Read more


Soundwave Hearing, LLC gets FDA nod for Sontro OTC Hearing Aids and otoTune app

Soundwave Hearing, LLC has created custom personalisation for its hearing aids to eliminate common barriers to accessing hearing aids.  Every device is set to each user’s particular hearing needs, said the US-based health tech company.  The Sontro hearing aids and otoTune app use a three-minute in situ hearing test to customise the self-fitting process.  The patented otoTune app simultaneously analyses both ears to provide clinically validated test results and customisation to meet each user’s hearing and listening needs, the health tech company said.

Sontro Self-Fitting OTC Hearing Aids is a Class II Medical Device that is said to combine the power of mobile phones and self-fitting AI technology to offer affordable hearing aids.

Soundwave Hearing, LLC has created custom personalisation for its hearing aids to eliminate common barriers to accessing hearing aids.

Every device is set to each user’s particular hearing needs, said the US-based health tech company.

The Sontro hearing aids and otoTune app use a three-minute in situ hearing test to customise the self-fitting process.

The patented otoTune app simultaneously analyses both ears to provide clinically validated test results and customisation to meet each user’s hearing and listening needs, the health tech company said.

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