Proscia’s Concentriq AP-Dx, a diagnostic software solution, revolutionizes pathology by offering an intuitive platform for viewing, interpreting, and managing whole slide images, driving efficiency and confidence among pathologists while streamlining collaboration. Supported by a multi-site clinical study, Concentriq AP-Dx’s 510(k) clearance confirms its non-inferiority to traditional glass slide reads, marking a significant milestone in improving cancer diagnosis and supporting laboratories in meeting the growing demands of precision medicine. With CE-IVDR certification and global licensing, Proscia continues to lead the digital pathology revolution, addressing the increasing pressure on pathologists and enhancing patient care worldwide.
ResMed (NYSE: RMD) introduces its AirCurve 11 series in the U.S., featuring bilevel positive airway pressure devices designed to improve comfort and compliance in sleep apnea therapy. With advanced technology including inspiratory and expiratory pressure adjustments, as well as personalized ventilation algorithms, the AirCurve 11 aims to align with patients’ natural breathing patterns while providing remote monitoring and management capabilities through integrated digital features like AirView and myAir. This latest innovation reflects ResMed’s commitment to patient-centric care and enhancing the therapy experience for individuals managing sleep apnea.
The medical technology industry continues to face job cuts in 2024, with companies like Illumina, Cue Health, Livanova, and Zimmer Biomet reducing their workforce amid economic pressures. Despite a positive economic outlook reported by some companies, layoffs persist, reflecting ongoing challenges in the industry, as highlighted by MedTech Dive’s coverage of recent layoffs.
Tuesday, February 13th
Mainstay Medical’s ReActiv8 Restorative Neurostimulation system receives FDA approval for full-body MRI compatibility, enabling safe scans for patients with chronic low back pain implanted with the device, expanding access to comprehensive imaging options. CEO Jason Hannon highlights the significance of this approval, emphasizing the device’s broadened safety profile and plans to pursue conditional MRI compatibility in other regions.
CMR Surgical introduces vLimeLite, an integrated fluorescence imaging system designed to visualize Indocyanine green (ICG) during surgery, providing surgeons using Versius Plus robotic system enhanced visualization of vessels, blood flow, and tissue perfusion. This significant update to Versius aims to address surgeons’ needs, offering a choice of viewing modes and ICG colors, with Gloucestershire Royal Hospitals NHS Trust being the first to install vLimeLite for upper GI surgeries, showcasing its potential to improve surgical outcomes.
GEDiCube, a subsidiary of Renovaro specializing in AI, has signed a letter of intent to acquire 75% of Cyclomics, a cancer diagnostic company, with plans to integrate their portfolios to advance AI-powered early cancer detection. Cyclomics’ technology, including CyclomicsSeq for early cancer recurrence monitoring and CyclomicsSeq TP53 for detecting oncogenic DNA mutations, is expected to complement GEDiCube’s AI platform, enabling more accurate and widespread cancer monitoring.
Wednesday, February 14th
Sparrow BioAcoustics introduces Stethophone™, an innovative software transforming smartphones into medical-grade stethoscopes, enabling users to capture, analyze, and share critical heart health data remotely. With FDA clearance for both medical professionals and consumers, Stethophone marks a milestone in personalized heart health, offering sophisticated bioacoustics technology and advanced visualizations to enhance diagnostic accuracy and efficiency. As Sparrow commemorates the launch on Valentine’s Day, CEO Mark Attila Opauzsky emphasizes the company’s dedication to empowering individuals in the fight against heart disease, with plans for future iterations integrating artificial intelligence functionalities.
Sunset HealthCare, a Chicago-based HME supplier, has entered a distribution agreement with Belluscura to offer the X-PLOR portable oxygen concentrator to over 1,600 customers, with plans to include the DISCOV-R POC later in 2024. Belluscura also appointed Konstantin Grey as VP of North American Sales, leveraging his extensive DME industry experience to drive growth and foster partnerships like the one with Sunset HealthCare, expanding Belluscura’s distribution network and bringing innovative products to the market.
Abbott and Fujirebio have joined forces to develop a research-use-only neurofilament-light chain (Nf-L) biomarker assay for Abbott’s Alinity i instruments, aiming to support research in various neurological diseases like multiple sclerosis and Alzheimer’s. This partnership marks Abbott’s commitment to enhancing diagnostics and therapeutics by exploring new biomarkers and making them accessible through its Alinity i platform, ultimately aiming to advance neuroscience research and improve patient care.
Thursday, February 15th
Merit Medical Systems has obtained FDA 510(k) clearance for its Scout MD surgical guidance system, expanding its oncology portfolio with a focus on improving the diagnosis and treatment of breast cancer and other soft tissue cancers. The Scout MD system features radar localization technology and multiple reflector configurations to precisely pinpoint tumor locations, potentially reducing the need for repeat surgeries and minimizing damage to surrounding healthy tissue, according to Merit’s CEO Fred P. Lampropoulos.
Inspira Technologies has obtained US patent approval for its orbiting blood oxygenation delivery system (VORTX), a crucial component of its INSPIRA ART500 device, designed to provide oxygen directly into the blood of awake patients. This patented system aims to revolutionize blood oxygenation technology by eliminating the use of fiber membranes, potentially reducing harmful effects associated with traditional oxygenators, according to Inspira CEO Dagi Ben-Noon. The INSPIRA ART500, equipped with Inspira’s HYLA blood sensor, promises continuous and precise blood parameter monitoring, with the HYLA sensor line achieving 95% accuracy compared to conventional blood gas analyzers, offering versatile and real-time data collection for various medical procedures.
A consortium including experts from University Hospitals Birmingham NHS Trust, the University of Birmingham, and industry partners Neotherix and Keighleycolo has developed a novel device called the “Seton-Scaffold Device” to treat anal fistulas, a condition affecting over 12,000 people a year in the UK. The device, funded by the NIHR invention for innovation (i4i) programme, combines a bioresorbable scaffold to heal the fistula with a thin seton for drainage, aiming to provide a less invasive and more effective alternative to current treatments, with potential for commercialization and global impact.
Friday, February 16th
AngioDynamics continued its streamlining efforts by completing the sale of its Picc and Midline product portfolios to Spectrum Vascular for up to $45 million in cash, alongside discontinuing the sale of other product lines, aiming to optimize its product portfolio and strengthen its strategic focus. President and CEO Jim Clemmer stated that these actions are part of the company’s transformation plan to concentrate on driving growth and profitability within specific high-growth markets, emphasizing research and development of specialty products.
The Wyss Center is developing AI algorithms that decode brain signals to control a lightweight exosuit, known as the Synapsuit project, aiming to support arm and hand movement in real-time for individuals with movement disorders. Collaborating with partners like Neurosoft Bioelectronics, the project seeks to advance brain-computer interface technology to restore functional mobility to those with severe upper-limb motor disabilities, combining flexible electrodes, neuro-AI decoders, and a soft exosuit for practical daily use.
Boston Scientific has successfully conducted the first post-FDA approval cases in the U.S. with its Farapulse pulsed field ablation system for treating atrial fibrillation (AFib), marking a significant milestone for the company. The approval allows for the use of Farapulse in isolating pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib, positioning it as a potentially transformative therapy option for patients with this condition.
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