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.
JUNE Medical has launched the eVeck Colposcopy Plume Evacuation Kit for the safe and efficient removal of surgical plume. Surgical plume is an unavoidable result of interventional procedures where diathermy, electrosurgery, laser and ultrasonic devices cut into tissue. It can release an unpleasant odour but, more importantly, can contain toxic, infectious or carcinogenic material – such as hydrogen peroxide gas, HPV or SARS-CoV-2 – that could be hazardous to theatre staff or indeed the patient. As a result, exposure to surgical plume has been linked to eye, nose and throat irritation, nausea, headaches, coughs, nasal congestion, asthma, and asthma-like symptoms.
The single use eVeck Kit comes ready assembled, with an integrated HEPA pre filter, a flexi connector that fits assorted speculum models, and tubing that links to a plume evacuation system and is reinforced to prevent crushing and kinking.
Renowned electro surgery consultant Steve Veck has worked on the project, advising medical device specialist Mosaic Surgical. He said: “Surgical plume is an inevitable consequence of procedures that use electrosurgical techniques, and there is clear evidence showing the dangers it presents to personnel. Despite this, the most efficient removal methods are not mandatory in every territory, or for every case. The eVeck eliminates this issue by attaching directly to the speculum, positioning it close to the surgical site to clear all the damaging materials before staff and patients can be exposed to them.”
Angela Spang, CEO of JUNE Medical, commented: “We are delighted to be able to offer this simple but vital solution that can prevent surgical teams from being exposed to the hazards of surgical plume. We hope that more widespread use of the eVeck Kit will have a significant long-term effect on improving the health of healthcare professionals.”
For more information, visit: junemedical.co.uk/eveck
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Canon Medical Systems USA recently launched SOLTUS 500 Mobile Digital X-ray, giving facilities access to a portable X-ray system that is equipped with enhancements that can streamline bedside exams to help improve workflow and productivity. This will help facilities that require rapid imaging exams performed in a variety of complex situations, often at the patient’s bedside.
The FDA-cleared SOLTUS 500 has a compact design with advanced features that promote efficiency and patient safety, without compromising image quality. Features include:
For more information, visit: us.medical.canon
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Medela Healthcare mobile suction devices – a safer alternative to wall vacuum – can help expand critical care capacity and support UK hospitals in the fight against COVID-19.
Used worldwide, the company’s portable medical suction machines are designed to provide crucial suction and fluid removal during respiratory treatment provided with ventilators.
Traditionally, hospitals ensure a patient’s airway is clear by utilising suction that relies on central wall piped vacuum. However, guidance published by the National Health Service advises hospitals against using piped vacuum to support infectious disease units to reduce the risk of virus spread and cross-contamination.
A previous study looking at contamination rates for wall-mounted suction units discovered contamination on over 30% of devices. Hence, portable medical suction machines are recommended for COVID-19 care. Medela offers a range of portable suction pumps which are available with a virus filter capable of reducing cross-contamination from COVID-19 with filtration efficiency of greater than 99.9%.
These compact devices offer flexibility to hospitals while reducing the risk of viral transmission. When used with disposable collection systems, portable suction machines reduce staff exposure to hazardous fluids, while devices equipped with virus filters further reduce risk of cross-contamination and viral exposure to staff.
Standard of care in the ICU requires each patient to be provided with a single suction device, which helps to decrease the risk of lung infections, prolonged hypoxia, and pooling of secretions in the lung.
For more information, visit: https://covid19. medelahealthcare.com/solutions
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Sony has introduced the LMD-X3200MD 32-inch medical grade LCD monitor with 4K HDR colour imaging. Its sleek design is optimized for hospital operating rooms, surgical centres and clinics.
It is designed to minimize reflected glare in brightly lit ORs, and the panel structure achieves clear, high-contrast images by controlling reflection and minimizing light dispersion in the LCD panel. This allows application of the monitor under various lighting conditions and avoids the need for ongoing adjustment of the monitor in the OR to remove potentially distracting reflections from surgical lights.
The LMD-X3200MD LCD panel and signal processing technology provide a wide colour gamut that complies with the ITU-R Recommendation BT.2020. Offering a wider colour gamut than the BT.709, colour reproduction is significantly improved with realistic visualisation. HDR technology also allows images to be produced with a wider range of brightness level, greater contrast, and rich colours. When receiving HLG (Hybrid Log-Gamma) signals from an HLG-compatible imaging system, users can simply select HLG in monitor gamma setting mode to display HDR images.
“We understand the critical importance in providing a surgeon with the highest quality image that enables greater depiction of finer anatomical structures through a simplified application,” explained Claire Bregeon, Product Marketing Manager for Healthcare at Sony Professional Solutions Europe. ‘‘With 4K resolution combined with HDR, you can see more detail in a dark body cavity and in bright areas with light reflections on membrane surfaces. If the surgeon sees better – they can perform better.”
The LMD-X3200MD also benefits from Sony’s unique A.I.M.E. (Advanced Image Multiple Enhancer) that allows you to adjust the view to enhance structure and colour for more comfortable viewing. This technology has been recently improved with new features including shadow enhancement and noise reduction. Parameters can also be set directly via the button on the front panel.
For more information, visit: www.sony.net
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Biotronik has introduced a new injectable cardiac monitor (ICM). The BIOMONITOR IIIm is equipped with a unique algorithm that significantly reduces false positive atrial fibrillation (AF) detections due to ectopic beats.
Physicians can lose time reviewing these nonactionable episodes. Research shows that 52% of false positive AF episodes occur due to premature ectopic beats, which can be falsely detected as AF.
According to Biotronik, the new device can achieve a 72% reduction in false positives while maintaining 100% of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy. This will make physicians’ workload more efficient.
These new features are supported by image quality comparable to those recorded on a gold-standard 12-lead ECG.
BIOMONITOR IIIm is also the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.
For more information, visit: www.biotronik.com/en-de/products/arrhythmiamonitoring/ biomonitorIIIm
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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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