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:


Medtronic wins FDA approval for new-generation Evolut TAVR system

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories, extreme, high, intermediate, and low, in the US.  Severe aortic stenosis is a condition where the aortic valve leaflets become stiff, thickened, and difficult to open and close, making the heart work harder to pump blood.  The new-generation TAVR system is designed to maintain the valve performance benefits of the legacy Evolut TAVR platform, and it facilitates coronary access.

The Evolut FX+ TAVR system is indicated for symptomatic severe aortic stenosis patients across all risk categories, extreme, high, intermediate, and low, in the US.

Severe aortic stenosis is a condition where the aortic valve leaflets become stiff, thickened, and difficult to open and close, making the heart work harder to pump blood.

The new-generation TAVR system is designed to maintain the valve performance benefits of the legacy Evolut TAVR platform, and it facilitates coronary access.

Read more


Precision Neuroscience launches two BCI clinical study sites in US

The Mount Sinai Health System and University of Pennsylvania Perelman School of Medicine sites will help understand how the brain regulates movement and help people with neurological conditions.  Layer 7 Cortical Interface is Precision Neuroscience’s brain implant with an electrode array made up of 1,024 miniature electrodes present across 1.5cm2.  The technology is designed to record neural activity in real-time at resolutions hundreds of times more detailed than conventional cortical surface arrays used in neurosurgical procedures.

The Mount Sinai Health System and University of Pennsylvania Perelman School of Medicine sites will help understand how the brain regulates movement and help people with neurological conditions.

Layer 7 Cortical Interface is Precision Neuroscience ’s brain implant with an electrode array made up of 1,024 miniature electrodes present across 1.5cm2.

The technology is designed to record neural activity in real-time at resolutions hundreds of times more detailed than conventional cortical surface arrays used in neurosurgical procedures.

Read more


Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date

U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers Myriad Genetics’s foundational and proprietary method of preparing cell free DNA.  This method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing.   Specifically, the patented method relates to the manner in which a sample is sufficiently enriched with ctDNA that it can be detected, if present, with high sensitivity and specificity.

U.S. patent 11,932,910, entitled Combinatorial DNA Screening, covers Myriad Genetics ’s foundational and proprietary method of preparing cell free DNA.

This method describes a key aspect of tumor-informed MRD assays that detect circulating tumor DNA (ctDNA) through sequencing.

Specifically, the patented method relates to the manner in which a sample is sufficiently enriched with ctDNA that it can be detected, if present, with high sensitivity and specificity.

Read more



novosound secures patent for wireless wearable ultrasound imaging platform

The milestone marks novosound’s 21st patent awarded since 2018, and gives the company the exclusive rights to sell the technology that has underpinned leading research in Scotland and the United States into wireless, wearable ultrasound.  Dr Dave Hughes, CEO and Co-founder of novosound, said: “I’m really proud that Novosound has obtained the first patent for a wearable ultrasound system.   This allows us to integrate and license the technology with smartwatch partners, looking deeper into the body and enhancing the measurements their optical and electrical sensors provide, opening up the holy grail of 24/7 blood pressure monitoring on the wrist.”

The milestone marks novosound ’s 21st patent awarded since 2018, and gives the company the exclusive rights to sell the technology that has underpinned leading research in Scotland and the United States into wireless, wearable ultrasound.

Dr Dave Hughes , CEO and Co-founder of novosound , said: “I’m really proud that Novosound has obtained the first patent for a wearable ultrasound system.

This allows us to integrate and license the technology with smartwatch partners, looking deeper into the body and enhancing the measurements their optical and electrical sensors provide, opening up the holy grail of 24/7 blood pressure monitoring on the wrist.”

Read more


IONIC Health secures FDA approval for nCommand Lite technology

nCommand Lite includes multi-modality capabilities including magnetic resonance (MR), computed tomography (CT) and positron emission tomography/CT (PET/CT) scanning.  The vendor-agnostic, multi-modality nCommand Lite system will be exclusively distributed by GE HealthCare, which will also provide remote patient scanning support and remote access.  GE HealthCare will also provide its ability to connect to remote experts who can provide real-time guidance to the licensed technologist operating the scanner.

nCommand Lite includes multi-modality capabilities including magnetic resonance (MR), computed tomography (CT) and positron emission tomography/CT (PET/CT) scanning.

The vendor-agnostic, multi-modality nCommand Lite system will be exclusively distributed by GE HealthCare , which will also provide remote patient scanning support and remote access.

GE HealthCare will also provide its ability to connect to remote experts who can provide real-time guidance to the licensed technologist operating the scanner.

Read more


Stryker rolls out Gamma4 Hip Fracture Nailing System in European markets

Gamma4, which is the latest Gamma system, offers surgeons the next generation of Stryker’s intramedullary nailing system.  The US-based company has designed the hip fracture nailing system for treating hip and femur fractures and optimise procedural workflows for surgeons.  In addition, it is intended to treat stable and unstable fractures in the intracapsular, subtrochanteric, trochanteric, and shaft sections of the femur, including osteoporotic and osteopenic bone.  The Gamma4 Hip Fracture Nailing System can also be used for the stabilisation of bones and correction of bone deformities in these areas, the medical technologies developer said.  Read more

Gamma4, which is the latest Gamma system, offers surgeons the next generation of Stryker’s intramedullary nailing system.

The US-based company has designed the hip fracture nailing system for treating hip and femur fractures and optimise procedural workflows for surgeons.

In addition, it is intended to treat stable and unstable fractures in the intracapsular, subtrochanteric, trochanteric, and shaft sections of the femur, including osteoporotic and osteopenic bone.

The Gamma4 Hip Fracture Nailing System can also be used for the stabilisation of bones and correction of bone deformities in these areas, the?medical technologies developer?said.

Read more


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