Medical Device Developments Weekly
Medical Device Developments
Latest news and insight on innovations in the Medical Device sector.
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:
Tyber Medical, LLC Medical Receives FDA Clearance on Plating System Line Extension
This additional clearance expands Tyber Medical, LLC Medical products’ healing capabilities and adds to their restorative portfolio.
The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, nonunions and fusions in the hand, wrist, foot and ankle.
The Anatomical Plating System provides versatility, precision and efficiency in one system, and is offered in both titanium and stainless-steel.
Visage Imaging Launches Visage Ease VP for Apple Vision Pro
Designed to take advantage of the unique capabilities of Apple Vision Pro, Visage Ease VP supports immersive, spatial experiences for diagnostic imaging and multimedia.
Visage Ease VP includes all the proven functionality of Visage Ease?, plus the exciting addition of Visage’s powerful cinematic rendering engine for stunning volume-rendered images in immersive space.
Anywhere, on-the-go access with Visage Ease VP has additional flexibility with virtual screens at more than 4K resolution per eye, the independence from environmental lighting restrictions, and the ability to interact with imaging seamlessly in your physical space.
Philips receives FDA clearance for X11-4t Mini 3D TEE ultrasound transducer
The Philips Mini TEE ultrasound transducer is a cardiovascular ultrasound technology designed for early diagnosis of structural heart disease.
The FDA clearance will allow the use of Philips ’ new X11-4t Mini 3D TEE transducer to serve more patients with enhanced cardiac care and overall comfort.
It has been authorised to be used on paediatric patients as small as 5kg, adults who are at complications risk, and complex cases like intensive care unit (ICU) patients.
Toku Eyes secures CE and UKCA mark approvals for CLAiR technology
Toku Eyes CLAiR technology provides rapid, accurate, non-invasive CVD risk assessments using standard retinal images captured during a routine eye exam.
The retina, which lies in the back of the eye, is the only part of the vascular system that can be photographed easily and non-invasively.
The AI-powered technology identifies elevated levels of cardiovascular risk by analysing the smallest changes in the retina and its vasculature.
Edwards Lifesciences gets FDA nod for Evoque tricuspid valve replacement system
The Evoque system comprises a nitinol self-expanding frame, intra-annular sealing skirt and tissue leaflets made from the company’s tested bovine pericardial tissue.
Edwards Lifesciences is offering the tricuspid valve replacement system in three different sizes, all of which are delivered through the same low-profile transfemoral 28F system.
The system is indicated for improvement of health status in patients with symptomatic severe TR despite optimal medical therapy (OMT), who are eligible for valve replacement procedures.
The FDA approval for the Evoque tricuspid valve replacement system follows a?CE Mark approval, granted in October last year.
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Boston Scientific secures FDA approval for Farapulse PFA System
Boston Scientific's Farapulse PFA System is designed to deliver pulsed field energy, optimise cardiac PFA therapy, and provide a simplified user experience.
It is indicated for the isolation of pulmonary veins during the treatment of drug-refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (AF).
The PFA System primarily contains three components, the Farawave Ablation Catheter, the Farastar Ablation Generator, and the Faradrive Steerable Sheath.
The Faradrive Steerable Sheath is complemented by the VersaCross Connect Access Solution to provide safe and effective access to the left side of the heart during procedures.
Hologic, Inc. secures FDA nod for Genius system to detect cervical cancer
Hologic, Inc.'s Genius Digital Diagnostics System comprises the Genius Digital Imager for image acquisition and the Genius Cervical AI algorithm for image analysis.
It also comes with the Genius Image Management Server for image storage and the Genius Review Station for local or remote case review.
With the FDA approval, Genius becomes the first and only FDA -approved digital cytology system to combine artificial intelligence (AI) with advanced volumetric imaging technology.
The complete system, which helps identify pre-cancerous lesions and cervical cancer cells, is scalable and designed to fit the present and future needs of laboratories, said Hologic.
Synchron acquires equity stake in thin-film maker Acquandas GmbH
Acquandas GmbH specialises in providing thin film components to the healthcare industry, particularly to medical device OEMs, and other industrial markets.
As part of the transaction, Synchron ’s CEO and founder Thomas Oxley will be appointed to the Acquandas GmbH Governance Council, and Synchron CTO Riki Banerjee as a board observer.
Based in New York City, Synchron is a neurotechnology company that develops an endovascular BCI to restore brain functionality in patients with severe paralysis.
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