Today (August 26th), Ansukang Medical (Suzhou) Co., Ltd. (hereinafter referred to as “Ansukang Medical”) announced the completion of a new round of 100 million yuan financing. The round of financing is jointly invested by Taiping Innovation, Junlian Capital, and Shengjing Jiacheng. The funds raised from the financing will mainly be used for promoting the market of unmanned ultrasonic knives, building a new generation of energy platforms, and preparing production capacity. Founded in 2020, Ansukang Medical has been focusing on the research and development of innovative medical devices since its establishment. It is an innovative medical device company based on its own core technology system, committed to providing Chinese medical workers with better and more convenient medical devices. At present, the main product launched by Ansukang Medical is the new generation of non host ultrasonic knife, which is also the world’s first split type non host ultrasonic knife. Compared with similar ...
On August 22nd, the National Medical Products Administration announced that it has recently approved the registration applications for two innovative products, the “Transcatheter Aortic Valve System” of Beijing Balance Medical Technology Co., Ltd. (hereinafter referred to as “Balance Medical”). The transcatheter aortic valve system is mainly used to treat aortic valve stenosis, and there are two main treatment options: surgical thoracotomy for valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). TAVR can be roughly divided into ball expanding and self expanding instruments. Compared to SAVR, TAVR has the characteristics of no need for thoracotomy and extracorporeal circulation, minimal trauma, and fast recovery, providing a safer treatment option for high-risk surgical patients. However, in the Chinese market, the penetration rate of TAVR is still relatively low, far below the global level, and a large amount of demand has not been met, with broad prospects. According to Frost&Sullivan data, there were ...
The White House might soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. By Katie AdamsThe White House could soon finalize a rule that will either save or cost patients billions of dollars in prescription drug costs. The rule concerns “copay accumulators,” which are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Typically, when patients receive copay assistance from pharmaceutical companies, the amount paid by the manufacturer helps reduce the patient’s out-of-pocket costs. But with copay accumulators, the assistance from the drugmaker is not counted toward the patient’s maximum limit on out-of-pocket expenses. In September of last year, Judge John D. Bates of the U.S. District Court for the District ...
The US Food and Drug Administration (FDA) has approved ARS Pharmaceuticals‘ neffy (epinephrine nasal spray) 2mg for the emergency treatment of allergic reactions (type I). The indications include life-threatening anaphylaxis in adults and children weighing a minimum of 30kg. Previously, only injectable epinephrine was available for such patients. Anaphylaxis is a severe allergic reaction that can quickly become fatal, necessitating immediate medical intervention. Common triggers include certain foods, medications and insect stings, with symptoms such as hives, swelling, and difficulty breathing typically manifesting within minutes of exposure. The approval of neffy is supported by data from four clinical studies involving 175 healthy adults. These studies compared the blood concentration levels of epinephrine after administering neffy or traditional epinephrine injections. The findings indicated that neffy delivers comparable epinephrine levels to those of injectable products. In addition to matching the epinephrine blood concentrations, neffy demonstrated similar increases in blood pressure and heart ...
Barrett’s esophagus is a condition where the lining of the esophagus changes due to chronic gastroesophageal reflux. Individuals with Barrett’s esophagus are at a slightly increased risk of developing esophageal cancer and require regular surveillance endoscopies. During these procedures, gastroenterologists collect numerous biopsies from the affected tissues. These samples are then cut into thin sections and placed on glass slides for examination under a microscope by pathologists. However, the tissue sections that pathologists view represent only about 1% or less of the actual biopsies and provide just a two-dimensional view, which can be misleading. Researchers are now conducting clinical studies of archived tissues from patients with the condition to develop computational 3D pathology methods for Barrett’s esophagus risk stratification. The research team at UW College of Engineering (Seattle, WA, USA) had previously invented 3D pathology methods to assess prostate cancer risk and shifted their focus on gastrointestinal applications of their ...
Many common tests for infectious diseases work by detecting either antigens related to the virus or antibodies created in response to the infection. These tests, which now include widely used COVID-19 rapid antigen tests, offer the advantages of speed and broad availability. However, polymerase chain reaction (PCR) tests still surpass these in terms of accuracy, reaching nearly 100%. PCR tests, considered the gold standard in infectious disease diagnostics, excel because they detect a pathogen’s genetic material like RNA directly. This capability increases specificity, reducing the likelihood of false positives. PCR can also amplify minimal amounts of genetic material, allowing it to detect infections at very low levels. Yet, PCR requires specialized skills and expensive equipment, which limits its availability, particularly in low-resource settings. Researchers at the University of Connecticut (Storrs, CT, USA) have now developed a platform technology that incorporates PCR-like capabilities within a handheld device, as detailed in ...
The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
Pneumococcus is the leading cause of pneumonia, meningitis and sepsis worldwide A study, published in Nature, has revealed a new way to map the spread and evolution of pathogens, as well as their response to vaccines and antibiotics, using anonymised mobile phone data, to help predict and prevent future outbreaks. The study involved researchers from the Wellcome Sanger Institute, the University of the Witwatersrand, the National Institute for Communicable Disease, South Africa and the University of Cambridge, as well as partners from the Global Pneumococcal Sequencing project. Infectious diseases, including tuberculosis, HIV and COVID-19, have multiple strains or variants that circulate simultaneously. The leading cause of pneumonia, meningitis and sepsis worldwide, the bacterium Streptococcus pneumoniae (pneumococcus) has over 100 types and 900 genetic strains globally. Researchers integrated genomic data from 6,910 pneumococcus samples collected in South Africa between 2000 and 2014 with anonymised human travel patterns collected by Meta2 using ...
The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were ...
A drug approved to treat certain autoimmune diseases and cancers successfully alleviated symptoms of a rare genetic syndrome called autoimmune polyendocrine syndrome type 1 (APS-1). Researchers identified the treatment based on their discovery that the syndrome is linked to elevated levels of interferon-gamma (IFN-gamma), a protein involved in immune system responses, providing new insights into the role of IFN-gamma in autoimmunity. The study, led by researchers at the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, was published today in the New England Journal of Medicine. In a three-stage study, conducted in mice and people, the researchers examined how APS-1 causes autoimmune disease. The syndrome is marked by dysfunction of multiple organs, usually beginning in childhood, and is fatal in more than 30% of cases. This inherited syndrome is caused by a deficiency in a gene that keeps the immune system’s T cells from attacking cells of ...
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