相关临床试验
64
15 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
进行中（未招募）
14
21.9%
已完成
37
57.8%
尚未招募
1
1.6%
招募中
7
10.9%
终止
3
4.7%
撤回
2
3.1%
暂无批准数据
- UBS raised its price target on Johnson & Johnson to $320 per share from $280, citing an inflection to 8%-plus top-line growth for the rest of the decade. - Analysts highlight Darzalex as the dominant first-line standard of care in multiple myeloma, projecting $22 billion to $23 billion in peak annual sales. - J&J's immunology franchise, including Tremfya and newly approved Icotyde, is positioned as a key growth driver, with Icotyde viewed as a potential $10 billion-plus opportunity. - The firm notes no major near-term patent cliffs, with Darzalex's U.S. exclusivity extending to 2029 and an anticipated gradual erosion curve rather than a cliff.
- A 46-year-old triple-negative breast cancer patient became the first in the U.S. to undergo single-port robotic nipple-sparing mastectomy at a community hospital outside a clinical trial at Sutter's Alta Bates Summit Medical Center. - The FDA cleared the da Vinci single-port surgical system for nipple-sparing mastectomies in December 2025, based on a 53-patient randomized trial showing no difference in short-term safety compared to traditional procedures. - A 2024 JAMA Surgery case series of 20 women reported that 95% of breast-skin sensation and 55% of nipple sensation were preserved after the single-port robotic procedure. - The technique is limited to a select group of patients based on cancer type, location, breast size and shape, and is not suitable for most women with breast cancer.
- The FDA cleared Johnson & Johnson's OTTAVA robotic-assisted surgery system, establishing the company's presence in the surgical robotics market. - The approval provides J&J with a potential long-term growth platform alongside its established pharmaceutical and medical-device businesses. - Analysts view OTTAVA as a growth catalyst rather than a serious competitive threat to Intuitive Surgical, suggesting market expansion potential. - J&J's oncology strategy is also emerging as a prominent growth engine, with the company emphasizing cancer treatments in its investment thesis.
- Abbott Laboratories reported FY 2025 revenue of nearly $44.3 billion with a net margin of approximately 14.7%, while completing its acquisition of Exact Sciences to expand into cancer diagnostics. - Intuitive Surgical achieved FY 2025 revenue close to $10.1 billion, representing approximately 20.5% growth, with a net margin of nearly 28.4% and a debt-free balance sheet. - Abbott faces headwinds including product liability exposure, $20 billion in acquisition-related debt, and FDA regulatory scrutiny, while Intuitive Surgical confronts tariff impacts and increasing RAS market competition. - Both companies remain leaders in their respective niches, with Abbott offering diversified stability and dividends versus Intuitive Surgical's high-growth, razor-and-blades recurring revenue model.
- Johnson & Johnson's Ottava Robotic Surgical System successfully met all primary safety and performance endpoints in the FORTE trial, a prospective study of 30 patients undergoing Roux-en-Y gastric bypass surgery. - Patients lost an average of 30 pounds (13.6kg) within 30 days post-surgery, with no conversions to open surgery reported during the procedures. - The company has submitted a De Novo application to the FDA based on these results and preclinical data, seeking approval for multiple gastrointestinal procedures including gastric bypass, sleeve surgeries, and upper abdominal operations. - The Ottava system features four robotic arms integrated into a standard surgical table, designed to fit existing hospital infrastructure and remove practical barriers to robotic surgery adoption.
- Restore Robotics received FDA 510(k) clearances for remanufacturing two additional da Vinci Xi robotic surgical instruments, expanding its portfolio of cost-effective alternatives to new equipment. - The company aims to transform robotic surgery economics by enabling healthcare providers to significantly reduce costs while maintaining surgical performance and reliability standards. - Through partnership with Encore Medical Device Repair, the expanded remanufacturing program offers hospitals meaningful cost reductions, increased sustainability, and seamless workflow integration.
- The FDA has granted 510(k) clearance for Intuitive Surgical's da Vinci 5 robotic system to perform certain cardiac procedures, including mitral valve repair and internal mammary artery mobilization for cardiac revascularization. - The approval marks a strategic re-entry into cardiac surgery for Intuitive Surgical, expanding the company's addressable market in a field where robotic-assisted minimally invasive surgery penetration remains low. - The da Vinci 5 features enhanced capabilities including 10,000-times greater computing power, smart instruments capturing over 1,000 data points per second, and advanced imaging for improved vessel visualization. - Intuitive Surgical plans to collaborate with a limited number of U.S. centers through 2026 to establish initial cardiac programs, supported by specialized training and cardiac-specific instrument development.
- The FDA has cleared Intuitive Surgical's da Vinci 5 robot for nine cardiac procedures including mitral valve repair, cardiac revascularization, and septal defect repairs. - The clearance covers non-force feedback instruments such as forceps, dissectors, and scissors for minimally invasive cardiac surgery applications. - Surgeons worldwide performed approximately 17,000 cardiac procedures using da Vinci systems in 2025, demonstrating growing adoption of robotic cardiac surgery. - Intuitive plans a measured rollout with comprehensive training and education support, while continuing to seek approval for force feedback instruments in cardiac applications.
- Swiss medtech company Distalmotion raised $150 million in Series G financing led by Revival Healthcare Capital to accelerate U.S. commercial expansion of its DEXTER surgical robot. - DEXTER has received three FDA authorizations for gallbladder, hysterectomy, and hernia repair procedures, with the compact mobile system designed to integrate into existing operating rooms without structural modifications. - The company is targeting the fast-growing ambulatory surgery center market, where DEXTER's streamlined design offers advantages over larger robotic platforms that require dedicated infrastructure. - DEXTER has already treated nearly 3,000 patients across Europe and the United States, demonstrating clinical adoption of the platform's seamless transition between laparoscopic and robotic surgical modes.
- SS Innovations successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025, meeting FDA requirements for usability and patient safety. - The company switched from a de novo request to the 510(k) regulatory pathway to potentially save time and costs, with submission planned for Q4 2025. - Based on standard FDA review timelines, the company expects potential clearance in the first half of 2026, which would enable market entry to compete with Intuitive Surgical. - The SSi Mantra system has demonstrated clinical success with 125 installations across six countries and over 6,000 surgical procedures performed to date.
