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 ...
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 ...
Today, the U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device industry, is part of the agency’s multi-pronged approach to reducing the use of ethylene oxide (EtO) where possible and further supports the agency’s efforts to advance medical device supply chain resiliency. Effective sterilization processes are necessary for certain devices to be safe because sterilization inactivates or kills potentially harmful microorganisms. In addition to effectively inactivating or killing potentially harmful microorganisms, sterilization processes must ...
Dive Brief The Food and Drug Administration posted a draft guidance on Monday clarifying how it evaluates real-world data in its decisions to clear or approve medical devices. The draft is an update to a final guidance in 2017 and includes more detail on how the agency assesses the relevance and reliability of real-world data, study design elements and recommendations on documentation for FDA review. An omnibus spending bill passed at the end of 2022 required the FDA to issue a draft guidance on the use of real-world data in premarket submissions. Two years after the public health emergency ended, the law also requires the FDA to specify how many requests for clearance or approval it has received and how many of those applications were approved or denied when real-world evidence was submitted. Dive Insight The 21st Century Cures Act, signed into law in 2016, created a framework for the ...
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 ...
Dive Brief CooperCompanies bought some of Cook Medical’s obstetrics, doppler monitoring and gynecology surgery products for $300 million, the companies announced on Wednesday. The acquisition follows an attempt by Cooper to acquire Cook’s reproductive health business, which was scrapped amid scrutiny from the Federal Trade Commission. The assets included in the purchase do not include any of the fertility products the companies had discussed in the original deal, Cooper said. Dive Insight Cooper paid $200 million upfront and will pay two more annual installments of $50 million each. In exchange, it will acquire Cook’s Bakri postpartum balloon, cervical ripening balloon, doppler blood flow monitor portfolio and other surgical products. Cooper CEO Al White said in the deal announcement that the acquired devices “are highly synergistic” with the company’s current portfolio and will strengthen its position in fertility and women’s health. San Ramon, California-based Cooper’s surgery segment includes fertility, gynecology and ...
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