On February 1, 2024, Fapon, a global leading life science company, and Bio Farma, a state-owned pharmaceutical holding company in Indonesia specializing in vaccines, life science products, and other pharmaceuticals, signed a memorandum of understanding to formalize their commitment to strengthening medical innovations in Indonesia. In doing so, the memorandum will further solidify Fapon’s global ecosystem for diagnostics and medical treatment. Jielun ZHU, Chief Financial Officer and Chief Investment Officer of Fapon, I.G.N. Suharta Wijaya, Finance and Risk Management Director of Bio Farma and Sri Harsi Teteki, Medical, Institutional and Governance Relations Director of Bio Farma attended the official signing ceremony. The partnership between Fapon and Bio Farma focuses on developing biological medicines and technologies, medical devices, and IVD solutions with an emphasis on healthcare localization. The goal is to foster a synergistic collaboration between the two companies, drive medical innovation and technology transfer, and boost the development of healthcare ...
Dive Brief Medical devices patients can use at home, such as infusion pumps and ventilators, are the top health technology hazard of 2024, a nonprofit patient safety organization said Wednesday. ECRI named at-home devices as the top hazard in response to examples of harms such as medication errors with the use of infusion pumps that suggest products “may be too complex for laypeople to use safely and effectively.” The group identified inadequate or onerous device cleaning instructions as the second biggest hazard of the year, reflecting evidence that reprocessing failures can spread infections. Dive Insight ECRI publishes a list of what it considers the top 10 health technology hazards each year. Devices given emergency authorization during the COVID-19 pandemic and cybersecurity threats topped its lists in 2021 and 2022, respectively, but the nonprofit has since focused on dangers related to at-home products. Last year, Philips’ recall of millions of respiratory ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has set out a regulatory roadmap to enable safe access to medical technology, including artificial intelligence (AI) and diagnostics. The Roadmap Towards the Future Regulatory Framework for Medical Devices will support the development of new regulations that will prioritise patient safety and help ensure individuals continue to have access to the devices they need without delay, while enhancing the UK’s position as “a world-leading environment for medical technology innovators,” the MHRA said. The roadmap is also set to offer “significant new opportunities for patients and healthcare” by enhancing the UK’s ability to benefit from advancing medical technology such as implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease. Dr Laura Squire, the MHRA’s MedTech regulatory reform lead and chief officer of healthcare, quality and access, said: “Today’s exciting medical technology advances offer important new opportunities for ...
Early detection, diagnosis, and treatment can significantly improve the survival and quality of life of cancer patients. Tumors continuously release fragmented genomic DNA into the bloodstream, although existing testing methods may find the signal too weak to be picked up in the early stages. Now, a revolutionary multi-cancer early detection solution leverages highly sensitive multi-omics technology to detect early cancer signals as well as predict the tissue of origin (TOO). Geneseeq Technology Inc.’s (Toronto, Canada) CanScan multi-cancer early detection solution is designed to enhance the early detection, diagnosis, and treatment of various cancers. This innovative solution harnesses the power of low-depth whole-genome sequencing (WGS) applied to circulating cell-free DNA (cfDNA) from a single tube of peripheral blood. It efficiently extracts genetic and fragmentomic features to identify early cancer signals with a high specificity of 99% and accurately predicts the TOO of cancers, thereby informing subsequent diagnostic and treatment strategies. Particularly ...
The era of medical insurance access management has arrived, the catalog of consumables has been dynamically adjusted, and many places have clearly supported the entry of new technologies and new consumables into medical insurance. 1. Original, patented and centralized purchasing consumables will be included in the medical insurance catalog with priority Recently, the Shaanxi Provincial Medical Insurance Bureau issued the “Notice of the Shaanxi Provincial Medical Insurance Bureau on Further Improving the Payment Management of Medical Insurance Medical Consumables” (hereinafter referred to as the “Notice”). It is clarified that the implementation of the access management of the medical insurance medical consumables catalog will be promoted and the province’s unified catalog of medical insurance medical consumables will be steadily formulated. According to the “Notice”, the payment management of medical insurance medical consumables must follow four principles: first, ensuring basics, second, encouraging innovation, third, being fair and open, and fourth, dynamic adjustment. ...
Drugdu.com expert’s response: In the Latin American region, several notable medical equipment trade shows attract industry professionals from around the globe. These events provide excellent opportunities for showcasing new technologies, networking with industry leaders, and gaining insights into the latest market trends. Some of the prominent trade shows in the Latin American medical equipment sector include: Hospitalar: Held in São Paulo, Brazil, Hospitalar is one of the most significant healthcare fairs in Latin America, offering a comprehensive showcase of medical equipment, hospital furniture, pharmaceutical products, and more. Meditech: This trade show takes place in Bogotá, Colombia, and focuses on medical technology and healthcare solutions, drawing exhibitors and attendees from various countries. Expo Med: Located in Mexico City, Mexico, Expo Med serves as a key event for medical device and supply professionals in Mexico and Central America, featuring a wide range of medical products and equipment. FIME (Florida ...
Drugdu.com expert’s response: Exporting medical equipment requires a thorough understanding of the regulatory requirements of both the exporting and importing countries, and involves several steps and essential documents: 1.Regulatory Compliance Compliance with Exporting Country Regulations: Ensure the medical equipment meets the regulatory standards of the country of origin. Compliance with Importing Country Regulations: Understand and comply with the medical device regulations of the destination country, which may include certifications like CE Marking (for Europe) or FDA approval (for the United States). 2.Essential Documents Export License: Depending on the type of equipment and the destination, an export license may be required. Commercial Invoice: Details the transaction between the exporter and importer. Packing List: Describes the contents and packaging details of the shipment. Bill of Lading or Airway Bill: Used for the shipment of goods. Certificate of Origin: States where the equipment was manufactured. Product Certifications: Documents like CE Certificate or FDA ...
Hunan Kecheng Instrument Equipment Co., Ltd., a leading manufacturer of medical centrifuges, is delighted to showcase its extensive range of products, including high-speed centrifuges, low-speed centrifuges, refrigerated centrifuges, blood bank centrifuges, and more. Our centrifuges are designed to cater to the needs of hospital laboratories, medical laboratories, and beauty institutions worldwide. Understanding that choosing the right centrifuge can be challenging, our low-speed centrifuges are tailored for hospital laboratories, especially for vacuum blood collection tube separation. We offer a unique solution with an automatic uncapping feature post-centrifugation, enhancing efficiency and reducing manual effort. Our patented rotor design for automatic uncapping includes multiple capacities, catering to different hospital requirements. Our product line includes: TD4K blood card special centrifuge: Ideal for blood type serology, routine blood tests, and immunoassays. TD4B cell smear centrifuge: Extensively used in immune blood laboratories for red blood cell serology and antigen identification. 3-5N urine sediment centrifuge: A ...
BY CHRIS NEWMARKER Microbot Medical today announced the successful completion of its pivotal pre-clinical study of its Liberty endovascular robotic surgical system. The study, performed under good laboratory practice (GLP) and essential for the company’s investigational device exemption (IDE) submission, took place under rigorous FDA guidelines. The study involved pigs. In this study, three interventional radiologists performed 96 robotic navigations using Liberty. They used the system to control various commercially available intravascular catheterization devices. They then microscopically examined and evaluated the target vessels and surrounding tissue. Microbot Medical officials think Liberty’s remote operation could enable it to democratize endovascular interventional procedures. “I am very pleased with the positive outcomes of the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, chief medical officer of Braintree, Massachusetts–based Microbot Medical. “This gives us confidence to move forward to the next stage of human clinical study.” Microbot Medical CEO ...
Dive Brief Vivos Therapeutics has received 510(k) clearance for the use of its oral devices in adults with severe obstructive sleep apnea (OSA). The Food and Drug Administration ruling, which comes 11 months after Vivos received clearance for an oral appliance in mild-to-moderate OSA, gives the green light to an application that was previously only possible off-label. The company’s trio of devices, called Complete Airway Repositioning and/or Expansion (CARE) oral appliances, include the DNA, mRNA and mmRNA products. Vivos’ share price increased nearly 834% to $41 when the market closed on Wednesday. The medtech company’s market capitalization was approximately $30.8 million even after the latest jump in its stock, according to Nasdaq. Dive Insight Vivos sells a set of airway repositioning and expansion devices for treating dentofacial abnormalities and OSA. The company has worked to add clearances to use more of the devices in the treatment of OSA, winning a ...
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