Philips has unveiled the industry’s first vendorneutral, multimodality, radiology operations command center to add secure, digital, virtual scanner access to existing imaging installs across multiple systems and sites.
RheinCell Therapeutics, a developer and manufacturer of human induced pluripotent stem cells (iPSCs) as starting materials for cell therapies, has received Good Manufacturing Practice (GMP) certification and Manufacturing Authorization. This marks a landmark achievement for RheinCell, which is now among a select few iPSCs manufacturers to have received the critical certification.
Bittium, a leading specialist for secure communications, connectivity, and medical technology solutions, has released a new version of Bittium Cardiac Navigator Holter ECG Analysis Software. The new Bittium Cardiac Navigator 1.4. Software version brings improvements to the P-wave detection. This will enhance the analysis accuracy of atrial fibrillation. The new version includes also minimum and […]
Swiss MedTech start-up Advanced Osteotomy Tools (AOT) has received CE certification for its patented CARLO® system which cuts bones precisely and contact-free with a specialized laser using a robot. CARLO stands for Cold Ablation Robot-guided Laser Osteotome.
GE Healthcare says its Serena Bright is now available in the United States following U.S. FDA 510(k) clearance. Serena Bright is the industry’s first contrast-enhanced guided biopsy solution allowing clinicians to conduct breast biopsy exams with contrast guidance using the same mammography equipment as that used for screening or diagnostic mammography.
Typically, for lesions found with contrastenhanced mammography and not seen on ultrasound, clinicians will use other imaging guidance, such as MRI, for biopsy procedures. Following an abnormal mammogram, it can take several weeks to get an MRI biopsy.
As the backlog of cancer screenings caused by Covid-19 persists, delays in diagnosis will likely lead to presentation at more advanced stages and poorer clinical outcomes, with one study pointing to a potential increase of 33,890 excessive cancer deaths in the U.S. alone.
Serena Bright may help decrease these delays, allowing follow-up biopsy procedures to be done in a matter of days, rather than several weeks for MRI biopsy. When compared to MRI-biopsy guided therapy, the potential benefits of Contrast Enhanced Spectral Mammography (CESM) biopsy include shortened procedure time and improved overall patient experience.
Key to this technology’s application is GE Healthcare’s SenoBright HD CESM, a diagnostic breast exam with iodine-based contrast that provides high sensitivity for more accurate breast cancer diagnosis.
By highlighting areas of unusual blood flow to localize lesions that need to be biopsied, CESM biopsy – Serena Bright – provides excellent image quality to help improve clinical confidence.
For more information, visit: www.gehealthcare.com/products/ mammography/serena-bright
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Materials scientists from Nanyang Technological University, Singapore have invented a new type of surgical glue that can bond blood vessels and close wounds, even when their surfaces are wet.
Named CaproGlu, it is activated by a low dose of ultraviolet light that cures it in seconds, turning it from a liquid glue into a solid but flexible biorubber – a biocompatible material that can be resorbed by the tissue after a few weeks.
Unlike current bio-adhesives – which need two chemicals to be mixed prior to use – the CaproGlu is a one-pot liquid gel solution that comes ready-to-use.
In a study published in Biomaterials in July they showed in animal experiments that blood vessels can be rejoined with just four stitches and a mesh wrapper dipped in CaproGlu, compared to the usual eight stitches that are required for a reliable and unobstructed join. The authors estimate that this will reduce surgery time by 25 per cent, as surgeons spend less time and effort stitching up blood vessels and tissues.
They also showed that CaproGlu can also be used to deliver local anaesthetics or pain relief medication to tissues in the body, which may be useful both during and post operation.
The adhesion strength of CaproGlu was compared to other commercial bioadhesives on the market and was found to be three to seven times stronger, and is on a par with the shear strength of collagen and muscle tissue found in the human body.
CaproGlu combines two ingredients into a single-component formulation that does not require additives. The first is polycaprolactone – a biodegradable polymer which has been approved by the United States Food and Drug Administration for specific applications used in the human body – and the second: diazirine, a light-sensitive molecule that can form strong bonds when activated.
The research team have filed for a provisional patent for the biorubber glue.
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Masimo has received FDA clearance of the Rad-G Pulse Oximeter, a rugged handheld device that provides clinically proven SET pulse oximetry, respiration rate from the pleth (RRp), and other vital parameters for both spot-checking and continuous monitoring. With its long-lasting rechargeable battery, robust rubber casing, light weight, and a convenient new direct-connect sensor capable of monitoring both adults and children, Rad-G makes it easier for clinicians to quickly assess patients and make informed decisions anywhere pulse oximetry or vital signs checking is needed. Providing the ultimate in handheld versatility, Rad-G can be used in a variety of settings, including but not limited to physicians’ offices, outpatient services, long-term care facilities, wellness clinics, first-response scenarios, and limited-resource environments.
Launching alongside the device, the new multipurpose, direct-connect Rad-G Sensor is indicated for monitoring both adult and paediatric patients. By eliminating the need to stock and carry multiple sensor types, the Rad-G Sensor further increases Rad-G’s versatility and ease of use, especially in more challenging field environments. In addition to this innovative new sensor, Rad-G is compatible with the vast portfolio of Masimo reusable and single-patient-use sensors, maximizing its flexibility and offering clinicians the ability to customize the solution based on the unique needs of each care setting.
The high-resolution screen displays a continuous pleth waveform and its fully configurable, audible alarms help alert clinicians to changes in patient status that may require their intervention.
In addition to Masimo SET oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi), Rad-G is also notable for its ability to use the same sensor to monitor respiration rate from the plethysmograph, with RRp. SpO2 and PR monitoring on Rad-G is provided using clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry.
For more information, visit: www.masimo.com
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Philips has introduced OmniWire, the world’s first solid core pressure wire for coronary artery interventional procedures.
Its breakthrough solid core construction enables physicians to more easily manoeuvre the wire in the patient’s circulatory system to measure blood pressure along the vessel and guide the delivery of catheters and stents.
The new wire supports iFR (instant wave-Free Ratio) measurements, the only resting index supported by randomized controlled outcome trials, as well as FFR (fractional flow reserve) measurements. It also integrates with the Philips IntraSight interventional applications platform, which can co-register iFR data onto the angiogram to precisely identify the parts of vessels requiring treatment.
Traditional pressure wires use a hollow metal tube (hypotube) to house the wiring that transmits the pressure information. Due to their thin walls, these wires can be challenging to manoeuvre and can sometimes kink, potentially becoming damaged during the procedure. OmniWire is the world’s first solid core pressure guidewire, using advanced conductive ribbons embedded in its outer polymer layer to communicate pressure information. The distal part of the wire is made from Nitinol, a super-elastic, durable material that is commonly used in non-diagnostic, interventional ‘workhorse’ guide wires. The proximal part of the wire is constructed from a highstrength cobalt alloy that provides the high durability required for complex and multi-vessel cases.
Commenting on the device, Dr. Jasvindar Singh, director of the catheterization lab at Barnes Jewish Hospital and associate professor at Washington University in St. Louis, U.S., who performed the first human case with OmniWire in the United States, said: “I have been very impressed with the handling of OmniWire, the new solid core design performed beautifully, and I was able to navigate the difficult case easily. We used iFR co-registration and found that the patient needed a stent. I was then able to perform the whole procedure working over OmniWire. This is truly an innovation in percutaneous coronary interventions.”
OmniWire has received clearance from the U.S. FDA and approval from the Japan Pharmaceuticals and Medical Devices Agency.
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Siemens Healthineers has introduced the Biograph Vision Quadra, a CE-marked positron emission tomography/computed tomography (PET/CT) scanner that is designed for clinical use as well as translational research.
In addition to the 3.2 mm silicon photomultiplier (SiPM) detector technology and Time of Flight (ToF) performance that are cornerstones of the established Biograph Vision PET/CT scanner, the Biograph Vision Quadra has an extended 106 cm axial field of view (FoV) – four times the PET axial FoV of the Biograph Vision 600. These technological features deliver significantly increased effective sensitivity and enable the clinician to image the average patient dynamically from the top of the head to the thigh in just one position. With the scanner’s extended axial FoV, the clinician can examine patient anatomy during radiopharmaceutical uptake over time. The combination of SiPM detectors and extended axial FoV permits more anatomical coverage in one bed position than a standard PET/CT scanner, enabling fast scanning at low patient radiation dose.
“The Biograph Vision Quadra is an order of magnitude more powerful than current state-of-the-art clinical scanners available today,” said James Williams, Head of the Molecular Imaging business at Siemens Healthineers. “This scanner will open possibilities for the imaging of complex and subtle biological processes that are key to the understanding of both physiology and pathophysiology alike.”
For more information, visit: www.siemens-healthineers.com/nl/molecularimaging/ pet-ct/biograph-vision-quadra
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Biotech scientists have developed a new polymeric heart valve, called the PoliValve, with a life span potentially longer than current artificial valves.
The PoliValve will also prevent the need for the millions of patients with diseased heart valves to require life-long blood thinning medication.
There are two artificial valves currently available for patients with diseased heart valves; both have limitations either in durability or in biocompatibility. Biological valves are made from fixed pig or cow tissue and have good biocompatibility, but limitations in durability of 10 to 15 years. Mechanical valves have very good durability, but poor biocompatibility and patients must take daily blood thinning drugs to prevent blood clots.
The PoliValve, created by Prof. Geoff Moggridge, Dr Marta Serrani and Dr Joanna Stasiak at Cambridge’s Department of Chemical Engineering and Biotechnology, and Prof. Raimondo Ascione, Head of the Translational Biomedical Research Centre (TBRC) at the University of Bristol, is made from a special co-polymer and is designed to resemble the flexibility, biocompatibility and durability of a natural heart valve. They have spent three years conducting developmental work and extra-vivo and in-vivo testing on the new PoliValve.
The device combines excellent durability with biocompatibility, addressing the limitations of current biological and mechanical artificial valves. It is made through a simple moulding process; hence it also reduces markedly manufacture and quality control costs.
Initial testing in animal has been undertaken at Bristol’s TBRC facility as a first mandatory in-vivo testing step to ensure safety. Long-term in-vivo testing is already planned and funded as a necessary additional step before bringing it to market.
According to the ISO standards a new artificial heart valve must withstand a minimum of 200 million repetitions of opening and closing during bench testing (equivalent to five-year life span) to be tested in humans. The new Cambridge- Bristol polymeric valve has comfortably surpassed this.
Prof. Ascione noted: “The transformational PoliValve results from an advanced Bristol/ Cambridge-based biomedical cross-fertilisation between experts in biomaterials, computational modelling, advanced preclinical development/ testing and clinical academics understanding the patient needs. The new valve could help millions of people worldwide and we aim to test in patients within the next five years.”
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April 2024
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