Don Tracy, Associate Editor The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets. Johnson & Johnson (J&J) announced that it has agreed to terms on acquiring Shockwave Medical, an intravascular lithotripsy (IVL) technology company focused on coronary artery disease (CAD) and peripheral artery disease. According to J&J, the deal is a part of its strategy to enhance the profile of its MedTech division, with an emphasis on the area of cardiovascular intervention. Shockwave Medical’s IVL technology is described as a minimally invasive treatment for calcified artery diseases that can also lead to reduced blood flow, pain, or heart attacks. Under terms of the deal, J&J is expected to acquire all outstanding shares of the company for $335.00 per share in cash.1 “Shockwave offers a truly differentiated opportunity to further enhance our leadership position in medtech, expand into additional high-growth segments, ...
The discomfort associated with traditional blood draws leads to a significant issue: approximately 30% of diagnostic tests prescribed by physicians are never completed by patients. This avoidance is often due to the fear of pain from needle sticks and a reluctance to visit medical facilities where there’s a perceived risk of encountering illness. Now, a virtually pain-free, low-cost, easy-to-use, whole blood and plasma collection and dispensing system solves the problem of the physical pain of a traditional blood draw, making it easier, cheaper, and faster to potentially receive a diagnosis. RedDrop Dx’s (Fort Collins, CO, USA) innovative blood collection device, RedDrop One, aims to enhance blood collection technology and patient care practices. With its user-centric design, RedDrop One eliminates many of the drawbacks associated with traditional blood collection methods, allowing for the collection of larger blood volumes more efficiently and with significantly less discomfort for the patient. This device is ...
Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
The Medicines and Healthcare products Regulatory Agency (MHRA) is warning the public not to buy counterfeit or unbranded anti-choking devices as they do not comply with device regulations and could cause harm. It is estimated that over 10,000 counterfeit or unbranded anti-choking devices, also known as airway clearance devices, choking rescue devices or emergency first aid devices, have been purchased by the public within the last two years based on listings found across online marketplaces like Amazon and eBay, and drop-shipping websites. There are currently two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA to be used after Basic Life Support protocols have been attempted and failed. Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to resolve the blockage and may worsen the situation by pushing obstructions further down the airway passage. ...
Identifying biomarkers for various cancers and diseases often relies on cell-free DNA, RNA, and extracellular vesicles. Traditionally, separating blood plasma to detect these markers requires centrifugation, spinning blood to isolate cells from plasma. Yet, even after multiple centrifugation cycles, some cells and platelets remain in the blood plasma, potentially releasing unwanted biological materials that can affect diagnostic accuracy. Researchers have now developed a compact, coin-sized chip capable of extracting blood plasma directly from a sample within 30 minutes, resulting in a more convenient and user-friendly option than the currently laborious centrifugation method. The chip named ExoArc, developed by scientists at Nanyang Technological University (NTU, Singapore), offers a one-step solution to achieve over 99.9% purity by efficiently removing blood cells and platelets. This advance promises quicker and more reliable clinical analysis of critical biomarkers. To demonstrate its utility, the team developed a portable prototype device (measuring 30cm x 20cm x 30cm) ...
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics. Traditionally, exosomes are isolated through ultrasound centrifugation, a process that requires eight hours or more, requires large sample volumes, and often harms the integrity of these delicate structures. Alternative methods also present challenges, including low purity and yield. Now, researchers have devised a diagnostic technique that employs sound waves to spin a single water droplet at speeds reaching 6,000 revolutions per minute, thereby facilitating the separation of tiny biological particles for exosome-based diagnostics. This novel approach involves a lightweight disk atop the spinning droplet and featuring etched channels that incorporate star-shaped nanoparticles designed for the label-free identification of exosomes. This method surpasses traditional techniques in efficiency, requiring less time and smaller sample volumes, and minimizes damage to the exosomes. It represents a significant ...
Today, the U.S. Food and Drug Administration (FDA) announced it is requesting $7.2 billion as part of the President’s fiscal year (FY) 2025 proposed budget. This funding will allow the agency to enhance food safety and nutrition, advance medical product safety, help support supply chain resiliency, strengthen the agency’s public-health and mission-support capacity, and modernize the FDA’s infrastructure and facilities. The request includes an increase of $495 million—or 7.4 percent above the FY 2023 funding level. The FDA’s request reflects the agency’s top priorities in key areas of importance for human and animal health. “The FDA continues to protect the health and well-being of millions of people,” said FDA Commissioner Robert M. Califf, M.D. “This new funding request will help us build on our accomplishments and also modernize our agency and operations as we plan for the future. Our request for critical investments will help us address our most urgent ...
Currently, mammography is the standard method for breast cancer diagnosis, but it has several limitations. The primary concern with mammograms is their lack of infallibility. False negatives can occur when normal breast tissue conceals cancer, and false positives may arise from anomalies that resemble cancer but are benign, causing unnecessary anxiety for patients. Additionally, the radiation involved in these tests could potentially contribute to the development of cancer over time. Now, a pain-free, low-cost, sensitive, radiation-free device that can detect breast cancer in urine with a sensitivity of 88.33% could bring about a shift in the diagnostic approach toward this disease. The Blue Box Biomedical Solutions (Barcelona, Spain) has developed an affordable, user-friendly, and portable device that can detect breast cancer using a urine sample. This device, known as the Blue Box, employs an innovative eNose (electronic nose) to detect the smell of urine. It features a chemical sensor array ...
Dive Brief The Food and Drug Administration has categorized Smiths Medical’s correction of more than 50,000 syringe pumps in the U.S. as a Class I recall. Smiths Medical, which became part of ICU Medical in a $2.35 billion takeover in January 2022, wrote to customers in December after identifying software problems that could cause its Medfusion 4000 syringe pump to fail. There has been one reported injury linked to the problem. The recall is the latest in a series of regulatory actions related to Smiths Medical. ICU Medical was still working to resolve a warning letter sent to Smiths Medical in 2021 and was facing falling sales of acquired products as of Sept. 30, according to its most recent quarterly results filing. Dive Insight The Class I recall applies to Model 4000 syringe pumps distributed between November 2010 and July 2023. The devices are designed to administer fluids such as ...
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