Medical Device Developments Weekly

Medical Device Developments Weekly

Focused on delivering its vision: The Sustainable Protection of Everyday Needs, kp is a global leader in rigid and flexible packaging, and specialty film solutions, serving the medical device, pharmaceutical, consumer packaging markets, amongst others. With a broad and innovative portfolio of packaging and product films and services, kp plays an integral role in the customer value chain by safeguarding product integrity, protecting brand reputation and improving sustainability.

?Werfen secures CE mark for Aptiva APS IgG and APS IgM reagents

?? Werfen secures CE mark for Aptiva APS IgG and APS IgM reagents  Werfen secured the CE mark under the European Union’s (EU) in-vitro diagnostic medical devices regulation (IVDR).  The Aptiva APS IgG and APS IgM reagents are immunoassays that leverage Aptiva particle-based multi-analyte technology (PMAT).   They are intended for semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma.  When used together with other laboratory findings, the IgG and APS IgM reagents will help in the diagnosis of primary and secondary APS.  Werfen research and development vice president Michael Mahler said: “Antiphospholipid syndrome is an autoimmune disease that manifests clinically as venous or arterial thrombosis and/or foetal loss and can be challenging to diagnose as its symptoms can mimic those of other conditions.  “Early diagnosis is crucial in preventing complications as well as unnecessary procedures and increased healthcare costs.  “Aptiva APS IgG and APS IgM deliver expanded information to clinicians to help with the diagnosis and management of patients with autoimmune diseases.”  Werfen said that its new Aptiva APS reagents will complement its previous Aptiva Celiac Disease and Connective Tissue Diseases (CTD) Essential reagents.  Read more online: https://lnkd.in/eJZucmGm  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #werfen #earlydetection

Werfen secured the CE mark under the European Union’s (EU) in-vitro diagnostic medical devices regulation (IVDR).

The Aptiva APS IgG and APS IgM reagents are immunoassays that leverage Aptiva particle-based multi-analyte technology (PMAT).

They are intended for semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GP1) IgG and IgM autoantibodies in human serum and citrated plasma.

Read more


Butterfly Network, Inc. unveils Butterfly iQ3 ultrasound system in US

??Butterfly Network, Inc. unveils Butterfly iQ3 ultrasound system in US  Butterfly iQ3 is a semiconductor technology-based, single-probe, whole-body ultrasound system. It was cleared by the US Food and Drug Administration (FDA) last month.  Butterfly Network, Inc. has powered the system with its most advanced P4.3 Ultrasound-on-Chip technology.  The semiconductor chip is said to have a data transfer rate that doubles that of its predecessor, improving frame rates, frequency and new 3D imaging capabilities.  Butterfly Network, Inc. president, CEO, and board chairman Joe DeVivo said: “Butterfly iQ3 is a pivotal moment in Butterfly’s trajectory, further validating the company’s initial hypothesis that semiconductor-based digital ultrasound is not only viable, but the future of all ultrasound.  “With the introduction of iQ3, we’re witnessing a paradigm shift in ultrasound. iQ3 sets a new standard where digital image quality matches that of traditional handheld devices and even certain carts.  “This device will attract more seasoned POCUS experts to choose Butterfly and support new learners to gain confidence and competency through artificial intelligence and advanced imaging tools.”  Read more online: https://lnkd.in/e3HUmkhd  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #butterflynetwork #ultrasound

Butterfly iQ3 is a semiconductor technology-based, single-probe, whole-body ultrasound system.

It was cleared by the US Food and Drug Administration (FDA) last month.Butterfly Network, Inc. has powered the system with its most advanced P4.3 Ultrasound-on-Chip technology.

The semiconductor chip is said to have a data transfer rate that doubles that of its predecessor, improving frame rates, frequency and new 3D imaging capabilities.

Read more


Avicenna.AI, Blackford Analysis to improve incidental pulmonary embolism detection

?? Avicenna.AI, Blackford Analysis to improve incidental pulmonary embolism detection  Under the partnership, Avicenna.AI will integrate its CE-marked CINA-iPE solution into the Blackford Analysis artificial intelligence (AI) platform.  The collaboration is expected to give enhanced capabilities to healthcare professionals to track incidental pulmonary embolism during routine CT scans.  Blackford Analysis founder and CEO Ben Panter said: “Blackford is always looking to enhance our AI portfolio to provide healthcare professionals with innovative tools to help enhance clinical efficiency and decision-making. “We’re delighted to add the CINA-iPE pulmonary embolism solution to our platform, further enhancing our existing trusted relationship with Avicenna.AI.”  With Blackford Analysis, medical practitioners can select from a wide range of over 115 AI solutions that are intended to enhance patient outcomes and boost clinical efficiencies.  The Blackford Analysis Platform now includes Avicenna’s CINA-iPE technology, giving medical professionals a strong tool for identifying lung blood clots during chest CT angiography.  Read more online: https://lnkd.in/dDW6Vyiy  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #avicennaai #blackfordanalysis

Under the partnership, Avicenna.AI will integrate its CE-marked CINA-iPE solution into the Blackford Analysis artificial intelligence (AI) platform.

The collaboration is expected to give enhanced capabilities to healthcare professionals to track incidental pulmonary embolism during routine CT scans.

The Blackford Analysis Platform now includes Avicenna’s CINA-iPE technology, giving medical professionals a strong tool for identifying lung blood clots during chest CT angiography.

Read more


Inspira Technologies gets US patent for orbiting blood oxygenation delivery system

?? Inspira Technologies gets US patent for orbiting blood oxygenation delivery system  VORTX, a core technology of the INSPIRA ART500 device, is designed to oxygenate blood without fibre membranes and transform the medical landscape.  The first-ever US patent approval included 16 claims by Inspira that were found to be new.  The patient’s blood cells suffer significant harm as a result of the existing fibre technologies employed for blood oxygenation, the medical technology company said.  In present fibre oxygenators, blood is forced to travel in a detrimental turbulent flow through multiple layers of fibres while encountering friction and shear forces within the fibre walls, in contrast to the normal laminar blood flow found in blood arteries inside the body.  Due to the fibre fabric’s substantial resistance to blood flow, high-pressure differences arise and harm the different components of blood, such as high haemolysis, damage to white blood cells, immune system activation, inflammatory system activation, and blood clotting.  Inspira Technologies CEO Dagi Ben-Noon: “We believe that this is a monumental advancement in the landscape of blood oxygenation technologies and a pivotal milestone and another key indicator of the INSPIRA ART500’s core technological portfolio.”  Read more online: https://lnkd.in/dVuRruBX  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #inspiratechnologies #respiratoryhealth

VORTX, a core technology of the INSPIRA ART500 device, is designed to oxygenate blood without fibre membranes and transform the medical landscape.

The first-ever US patent approval included 16 claims by Inspira that were found to be new.

The patient’s blood cells suffer significant harm as a result of the existing fibre technologies employed for blood oxygenation, the medical technology company said.

Read more


Maxx Orthopedics Inc. to collaborate with THINK Surgical for robotic TKA

?? Maxx Orthopedics Inc. to collaborate with THINK Surgical for robotic TKA  Through this collaboration, THINK Surgical will add Maxx Orthopedics Inc.’ implants, including the Freedom Knee System, to THINK Surgical’s ID-HUB, a proprietary database of implant modules for use with its TMINI Miniature Robotic System.  THINK Surgical is committed to providing open platform orthopedic surgical robots that support implants from multiple manufactures.  To further this commitment, THINK is pleased to add Maxx Orthopedics Inc. implants to its ID-HUB database which already includes five implant systems from four other implant manufacturers.  Adding another implant partner’s products to the ID-HUB database enhances customer’s choice of implant options when using the TMINI system.  The TMINI system includes a wireless robotic handpiece that assists surgeons in performing total knee replacement and first received 510(k) clearance from the U.S. FDA in April 2023.  The addition of the Freedom Knee System to THINK Surgical’s ID HUB database will allow Maxx Orthopedics Inc. customers in the U.S. access to robotic assisted technology for total knee replacement.  Read more online: https://lnkd.in/edtdyhaz  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #maxxorthopedics #thinksurgical

Through this collaboration, THINK Surgical will add Maxx Orthopedics Inc.’ implants, including the Freedom Knee System, to THINK Surgical’s ID-HUB, a proprietary database of implant modules for use with its TMINI Miniature Robotic System.

THINK Surgical is committed to providing open platform orthopedic surgical robots that support implants from multiple manufactures.

To further this commitment, THINK is pleased to add?Maxx Orthopedics Inc. implants to its ID-HUB database which already includes five implant systems from four other implant manufacturers.

Read more


Johnson & Johnson MedTech rolls out TECNIS PureSee intraocular lens in EMEA

?? Johnson & Johnson MedTech rolls out TECNIS PureSee intraocular lens in EMEA  The TECNIS PureSee features a unique, purely refractive design that offers uninterrupted, high-quality, vision with high contrast and low-light performance, comparable to a monofocal IOL.  According to Johnson & Johnson MedTech, surgeons and patients make trade-off decisions when choosing an IOL, considering its clear sight, spectacles, price, and possible glares and halos.  Its TECNIS PureSee IOL will address the issues and improve the overall outcomes for both patients and surgeons, said the eye health technology company.  Johnson & Johnson MedTech Vision EMEA president Jacqueline Henderson said: “Cataract surgery is the number one surgery performed globally, with 28 million procedures each year.  “But only 10-15% of patients are getting advanced optical IOLs specifically designed for astigmatism and presbyopia.  “Today, we’re proud to launch the TECNIS PureSee IOL, giving surgeons and patients the choice of a premium IOL that combines clarity of vision and reduced visual symptoms.”  Building on its purely refractive design, TECNIS PureSee IOL ensures surgeons’ ease of use in providing high tolerance to refractive error.  It offers important benefits, including uninterrupted high-quality vision, with superior distance and intermediate vision, along with functional near vision for spectacle independence.  Read more online: https://lnkd.in/eWTa3fMj  ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter  #MedicalDeviceDevelopments #johnsonandjohnson #cataractsurgery

The TECNIS PureSee features a unique, purely refractive design that offers uninterrupted, high-quality, vision with high contrast and low-light performance, comparable to a monofocal IOL.

According to Johnson & Johnson MedTech, surgeons and patients make trade-off decisions when choosing an IOL, considering its clear sight, spectacles, price, and possible glares and halos.

Its TECNIS PureSee IOL will address the issues and improve the overall outcomes for both patients and surgeons, said the eye health technology company.

Read more


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Medical Device Developments The medical device and diagnostic industry is currently valued at over $350bn. Technological advances in medical device and diagnostics design are driven by an increasingly demanding market and legislative requirements. A growing patient population and a worldwide governmental drive towards preventive therapies are also fuelling the development of innovative devices. Medical Device Developments is published in response to the increasing information needs of the major global medical device manufacturers/OEMs. The publication, which is published biannually, will incorporate authoritative reviews of current trends and emerging technologies, and provide the industry’s decision-makers with clear, concise and unbiased technical articles and case histories on cutting-edge developments, products and applications, drawing on the expertise of leading engineers and designers from around the globe.

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