Medical Device Developments Weekly

Medical Device Developments Weekly

Medical Device Developments Medical Device Developments

Medical Device Developments

Latest news and insight on innovations in the Medical Device sector.

发布日期: 2024年4月17日
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On June 25-27, 2024, RAPID + TCT will return to the West Coast for the first time in nearly a decade! The three-day event will feature the latest in 3D-printing technology from the industry’s leading product and service providers, a full schedule of speakers including a keynote series, and over 125 hours of educational content. The expansive show floor will showcase over 400 exhibiting companies’ latest advancements. Start planning your trip to sunny Southern California to experience North America’s largest additive manufacturing and industrial 3D printing event!

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:

3D Systems Corporation secures FDA approval for VSP PEEK Cranial Implant

?? 3D Systems Corporation secures FDA approval for VSP PEEK Cranial Implant The US-based 3D printing company has developed the VSP PEEK Cranial Implant using a complete FDA-approved workflow, including segmentation and 3D modelling software. The implant was produced on the company’s EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), using a pre-defined production process. 3D Systems Corporation said that by using additive manufacturing solutions, it can produce patient-specific cranial implants with up to 85% less material than traditional machining. Also, the cleanroom-based architecture of its printer, and simplified post-processing workflows will allow producing patient-specific medical devices at the hospital site with faster turnaround. 3D Systems Corporation medical devices SVP and general manager Gautam Gupta said: “As a leader in medical device innovation, 3D Systems prides itself on pioneering advancements that benefit both surgeons and patients. “Receiving FDA clearance for our VSP PEEK Cranial Implant solution is a significant milestone in our journey. Our EXT 220 MED printing system has already enabled the production of nearly 40 cranial implants in support of successful cranioplasties throughout Europe. “With this FDA clearance, we are now able to bring VSP PEEK Cranial Implant to the U.S., setting a new standard of excellence for these procedures. “We are now looking to the next applications for this technology, which includes 3D-printed spine interbody fusion implants, carbon fibre-reinforced PEEK for plating applications in trauma and fixation, and bioresorbable polymers for large bone and craniomaxillofacial applications.” Read more online: https://lnkd.in/eMY_Pigp ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#3dsystems hashtag#3dprinting

The implant was produced on the company’s EXT 220 MED 3D printer, Evonik VESTAKEEP i4 3DF PEEK (polyetheretherketone), using a pre-defined production process.

3D Systems Corporation said that by using additive manufacturing solutions, it can produce patient-specific cranial implants with up to 85% less material than traditional machining.

Also, the cleanroom-based architecture of its printer, and simplified post-processing workflows will allow producing patient-specific medical devices at the hospital site with faster turnaround.

Read more

Adherium secures FDA nod for Hailie Smartinhaler for COPD, Asthma

?? Adherium secures FDA nod for Hailie Smartinhaler for COPD, Asthma The Smartinhaler is designed to be compatible with AstraZeneca’s Airsupra and BREZTRI AEROSPHERE? (budesonide, glycopyrrolate, and formoterol fumarate) HCP inhalation devices. Airsupra is an FDA-approved rescue medication for asthma patients and Breztri is a triple combination therapy for chronic obstructive pulmonary disease (COPD) patients. Hailie Smartinhaler is a significant step forward in the management of asthma and COPD. The device offers patients and healthcare providers enhanced monitoring capabilities and personalised treatment approaches, said the digital health company. Adherium CEO Paul Mastoridis, Pharm.D. said: “Our mission at Adherium has always been to revolutionise the way respiratory conditions are managed. “By securing FDA clearance for our Smartinhaler with Airsupra and Breztri, we’re bringing that vision to life, offering patients and healthcare providers a powerful tool in the fight against chronic respiratory diseases.” According to Adherium, AstraZeneca’s Airsurpa and BREZTRI AEROSPHERE? (budesonide, glycopyrrolate, and formoterol fumarate) HCP are at the forefront of respiratory care, providing patients with advanced treatment options. Read more online: https://lnkd.in/eQvBvz9q ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#adherium hashtag#smartinhalers hashtag#asthma

The Smartinhaler is designed to be compatible with AstraZeneca’s Airsupra and BREZTRI AEROSPHERE? (budesonide, glycopyrrolate, and formoterol fumarate) HCP inhalation devices.

Airsupra is an FDA-approved rescue medication for asthma patients and Breztri is a triple combination therapy for chronic obstructive pulmonary disease (COPD) patients.

Hailie Smartinhaler is a significant step forward in the management of asthma and COPD.

Read more

Getinge secures EU approval for Advanta V12 covered stent system

?? Getinge secures EU approval for Advanta V12 covered stent system The covered stent system is intended for use with patients suffering from aortoiliac occlusive disease (AIOD), including lesions at the aortic bifurcation. The regulatory approval shows that the system aligns with the EU’s medical device regulations. Getinge said that its Advanta V12 covered stent system features versatility, precision, and predictability. The system, backed by decades of clinical and real-world evidence, has been addressing the needs of surgeons and patients for more than 20 years, said the medical device maker. Getinge vascular systems vice president Chad Carlton said: “Receiving the new EU MDR certification is a proud moment for Getinge. It is a clear reflection of our strategic vision, accompanied by the hard work and persistence of our team. “This investment in regulatory excellence not only supports our growth ambitions and future endeavours but also reinforces our commitment in making a positive impact on the lives of the patients we serve.” Read more online: https://lnkd.in/eYNivwhT ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#getinge hashtag#stent

The covered stent system is intended for use with patients suffering from aortoiliac occlusive disease (AIOD), including lesions at the aortic bifurcation.

The regulatory approval shows that the system aligns with the EU’s medical device regulations.

Getinge said that its Advanta V12 covered stent system features versatility, precision, and predictability.

Read more

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.

The ZEISS Medical Technology Surgery Optimizer the Apple Vision Pro could revolution not only ophthalmology but how we look at surgical video going forwards

??Is the new Apple Vision Pro a game changer in ophthalmology? Paired with the The ZEISS Medical Technology Surgery Optimizer the Apple Vision Pro could revolution not only ophthalmology but how we look at surgical video going forwards. See renowned ophthalmologist Tommy Korn, MD, tests the ZEISS Medical Technology Surgery Optimizer app for the Apple Vision Pro. The ZEISS Medical Technology Surgery Optimizer is an AI-powered application that radically simplifies the entire process of storing, reviewing and accessing surgical videos, and that allows you to gain insights into your cataract surgeries. Find out more here: https://lnkd.in/eErc9ZPq Video Courtesy of ZEISS Medical Technology ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#zeissmedicaltechnology hashtag#applevisionpro

Paired with the The ZEISS Medical Technology Surgery Optimizer the Apple Vision Pro could revolution not only ophthalmology but how we look at surgical video going forwards.

领英推荐

See renowned ophthalmologist Tommy Korn, MD, tests the ZEISS Medical Technology Surgery Optimizer app for the Apple Vision Pro.

The ZEISS Medical Technology Surgery Optimizer?is an AI-powered application that radically simplifies the entire process of storing, reviewing and accessing surgical videos, and that allows you to gain insights into your cataract surgeries.

Read more

Medtronic unveils next-gen GI Genius software, partners with ModMed

????? Medtronic unveils next-gen GI Genius software, partners with ModMed The healthcare technology company has introduced ColonPRO, the new-generation software for the GI Genius intelligent endoscopy system. GI Genius is a computer-aided detection (CADe) system that uses AI to identify colorectal polyps and was well-researched with more than 30 academic and real-world publications. The ColonPRO software allows the GI Genius system to boost AI-driven polyp detection. The system is supported by a dataset that is double the size of the previous one, which enables a notable improvement in its detection capabilities and reduction in false positives. In addition, the GI Genius system incorporates a new feature that automates physicians’ workflow, reduces documentation, and enables future integration with electronic health records. The system also comes with enhancements to the user interface, to facilitate the development of third-party applications through the AI Access platform, which was introduced last year. Medtronic Endoscopy business president Raj Thomas said: “Through our collaboration with ModMed, we can continue to help gastroenterologists achieve greater efficiency by streamlining workflows and leveraging augmented decision-making, freeing up valuable time for patient care. “We are committed to working with industry leaders and focusing on where we can best offer innovation, addressing unmet clinical needs and elevating the standard of care.” ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#medtronic hashtag#endoscopy

The healthcare technology company has introduced ColonPRO, the new-generation software for the GI Genius intelligent endoscopy system.

GI Genius is a computer-aided detection (CADe) system that uses AI to identify colorectal polyps and was well-researched with more than 30 academic and real-world publications.

The ColonPRO software allows the GI Genius system to boost AI-driven polyp detection.

Read more

AI Image Guided therapy is changing the way we look at precision care

?? hashtag#AI Image Guided therapy is changing the way we look at precision care The emergence of image-guided therapy shows just what's possible in the delivery of precision care. GE HealthCare’s ASSIST solutions combine advanced imaging, digitisation and hashtag#AI solutions to make it possible to treat many conditions, like prostate artery embolization, with little to no surgical incisions. The technology allows for more accurate targeting and monitoring of the treatment processes, leading to better outcomes for patients. By integrating imaging, navigation and therapy delivery, image-guided therapy is revolutionising minimally invasive procedures and making personalised data driven care more common. Video Courtesy of GE HealthCare ?? Follow Medical Device Developments to receive the latest medical device news daily and to subscribe to our weekly newsletter hashtag#MedicalDeviceDevelopments hashtag#gehealthcare hashtag#prostatesurgery hashtag#personalisedhealthcare


The emergence of image-guided therapy shows just what's possible in the delivery of precision care.

GE HealthCare’s ASSIST solutions?combine advanced imaging, digitisation and #AI solutions to make it possible to treat many conditions, like prostate artery embolization, with little to no surgical incisions.

The technology allows for more accurate targeting and monitoring of the treatment processes, leading to better outcomes for patients.

Read more

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Until next week.

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