相关临床试验
5
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
3
60.0%
Unknown
2
40.0%
暂无批准数据
- Cook Medical and Siemens Healthineers have partnered to develop the Interventional MRI Suite (iMRI), described as the first integrated, ionizing radiation-free solution for minimally invasive procedures. - The technology combines MRI's soft tissue contrast with real-time imaging capabilities, allowing clinicians to detect smaller lesions and tumors while providing immediate diagnostic results during the same procedure. - The iMRI suite targets applications in interventional oncology, pediatrics, and structural heart procedures, offering radiation-free precision guidance that could transform current diagnostic and treatment paradigms. - Unlike traditional MRI processes that require patients to wait months for results, the new system enables same-day diagnosis and treatment, with patients receiving immediate confirmation of cancer detection and intervention.
- Basecare Medical's GEMS culture medium (VitBase) has received NMPA approval, marking the first domestic registration of this internationally recognized embryo handling solution in China. - The approval breaks a 30-year monopoly by international manufacturers in China's embryo culture medium market and establishes Basecare as one of few companies with CE, FDA, TGA, and NMPA certifications. - The localized production is expected to enhance supply chain security, reduce treatment costs, and improve accessibility for Chinese IVF patients while maintaining international quality standards. - VitBase represents the first of 11 GEMS series products to receive Chinese registration, with the complete product line covering the entire assisted reproduction process.
- Piccolo Medical has received FDA 510(k) clearance for its second-generation SmartPICC Stylet and PM2+ System, marking a significant advancement in peripherally inserted central catheter placement technology. - The SmartPICC technology provides real-time bedside catheter tip confirmation using cardiac electrical activity, eliminating the need for confirmatory chest X-rays and reducing patient care delays. - The system incorporates proprietary ionic dilution technology for PICC navigation, offering clinicians real-time guidance during catheter insertion and immediate detection of improper vascular advancements. - Piccolo Medical has partnered with Spectrum Vascular as the exclusive North American distributor to commercialize this comprehensive vascular access solution.
- Cook Medical has recalled nearly 27,000 Beacon Tip 5.0 Fr Angiographic Catheters due to tip separation issues that have caused three serious injuries. - The FDA classified this as a Class I recall, the most serious type, warning that continued use could result in severe complications including sepsis, embolism, or cardiac arrhythmia. - The company identified the fault as resulting from process deviation by one specific operator and has instructed customers to immediately quarantine unused devices. - This marks the third recall of Beacon devices by Cook Medical, with previous recalls occurring in 2015 and 2016 for similar tip separation issues.
- FUJIFILM Irvine Scientific has agreed to sell its Medical Media Business Unit to European private equity firm Astorg, with the transaction expected to close on April 1, 2025. - The Medical Media Business Unit specializes in products for in vitro fertilization (IVF), infertility research, and cytogenetic analysis, expanding Astorg's reproductive health business portfolio. - This acquisition integrates with Astorg's growing MedTech platform, which recently added Hamilton Thorne and Cook Medical's Reproductive Health business. - The sale allows FUJIFILM Irvine Scientific to focus on its core life sciences operations and accelerate investments toward market growth in cell culture solutions.
- A recent analysis highlights concerns regarding the safety data of inferior vena cava (IVC) filters, devices implanted to prevent blood clots. - The analysis points to potential flaws in the clinical trial design that may have obscured critical safety issues with the IVC filter. - Lack of transparency from both the FDA and device manufacturers regarding safety data raises concerns about patient safety and informed consent.
- A study reveals significant safety risks associated with Cook Medical's Celect filter, designed to prevent blood clots from reaching the lungs. - Internal documents from Cook Medical omitted substantial risks, including deaths and serious complications, during the FDA approval process. - Yale Law School's Media Freedom and Information Access Clinic (MFIA) played a crucial role in unsealing documents related to the Celect filter. - The study highlights the need for greater transparency in medical device regulation and the importance of public access to critical health information.
• Zenflow has raised $24 million in Series C funding to support the FDA Pre-Market Approval (PMA) submission for its Spring System, a BPH treatment. • The Spring System is designed to alleviate urinary obstruction by gently propping open the urethra, preserving natural anatomy and function. • Clinical trial data demonstrates promising outcomes in symptom relief, urinary flow rates, and preservation of sexual function, with a strong safety profile. • Cook Medical's investment reflects confidence in Zenflow's technology and commitment to providing patient-friendly BPH treatment options.
- Endospan has concluded enrollment in the primary arm of the TRIOMPHE study, evaluating the NEXUS stent graft for aortic arch disease treatment. - The NEXUS device, already CE marked in Europe, aims to provide a less invasive, off-the-shelf solution for complex aortic arch pathologies. - The TRIOMPHE trial, conducted across 30 US and one New Zealand site, will monitor patient safety and efficacy for one year. - Early trial results suggest the NEXUS stent graft demonstrates safety in high-risk surgical patients, potentially revolutionizing aortic arch disease treatment.
- Cook Medical's Zilver PTX drug-eluting peripheral stent achieved FDA approval as the first device of its kind approved for peripheral artery use in the United States. - The device combines mechanical stenting with paclitaxel drug coating to reduce follow-up procedures by more than 50 percent in femoropopliteal artery treatment. - OhioHealth Riverside Methodist Hospital became the first U.S. institution to commercially implant the Zilver PTX stent following FDA approval. - The stent maintains arterial blood flow in seven out of ten patients through 24 months after implantation in the superficial femoral artery.
