相关临床试验
13
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
1946
已完成
6
46.1%
招募中
7
53.9%
暂无批准数据
- Stryker received FDA De Novo authorization on July 17 for SportSuite Vision, the first surgical application authorized for intraoperative use with Apple Vision Pro. - The first procedure using SportSuite Vision, a hip arthroscopy, was successfully completed at Duke Health, a leading academic medical center. - SportSuite Vision brings arthroscopic video, HipCheck, HipMap, and CT imaging into a customizable spatial computing environment to streamline operating room workflows. - The technology aims to reduce reliance on traditional monitors and support a more ergonomic, connected digital operating room for surgeons.
- McKesson disclosed unauthorized access and data exfiltration from third-party applications in an SEC filing on August 28, 2026, after detecting the intrusion on August 25, 2026. - The extortion group ShinyHunters claims it stole roughly 284 million data records from McKesson's Snowflake and Salesforce environments, a figure representing database rows rather than confirmed unique patients. - Hackers say they used vishing calls to hijack Okta single sign-on accounts, then moved laterally into cloud systems over a four-day window between August 21 and August 25. - ShinyHunters demanded a ransom of $55,236,150 with a 72-hour deadline; McKesson reportedly never responded, and the company has declined to confirm how many individuals were affected.
- ARPA-H has awarded Siemens Healthineers up to $31.1 million over five years to develop autonomous, remote endovascular robotics for acute ischemic stroke treatment. - The technology aims to enable robots to perform mechanical thrombectomy without direct human input, expanding access beyond comprehensive stroke centers. - Siemens Healthineers will contribute $5.4 million as a cost share, bringing total combined investment to as much as $36.5 million. - The funding is part of ARPA-H's Autonomous Interventions and Robotics (AIR) program, which awarded up to $175.3 million across multiple recipients including Philips and Magnendo.
- Wolfe Research upgraded Abbott Laboratories to Outperform from Peer Perform, setting a $130 target price on the healthcare and diagnostics company. - AbbVie was also upgraded to Outperform from Peer Perform at Wolfe Research, with a $300 target price objective. - The upgrades came as markets rallied broadly after consumer price index data landed in line with expectations at 3.4% year-over-year. - Stryker was cut to Peer Perform from Outperform at Wolfe Research, while Monopar Therapeutics was downgraded to Neutral from Overweight at Cantor Fitzgerald.
- A series of cyberattacks on medtech sponsors, including Boston Scientific and Medtronic, has exposed how sponsor-hosted eClinical infrastructure failures can disrupt active clinical trials mid-study. - When sponsor IT systems go down, sites lose simultaneous access to EDC, IRT/RTSM, eISF, and monitoring dashboards, creating a source documentation crisis and a cascade of protocol deviations. - ICH E6(R3) Section 5.5 and FDA guidance place the contingency-planning burden on sponsors, yet most site SOPs lack a pre-authorized decision tree for initiating backup protocols during an outage. - Sites and sponsors need cyberattack-specific contingency plans, including pre-authorized backup procedures and communication channels independent of the sponsor's compromised IT environment.
- The global 3D printing medical devices market is projected to grow from USD 3.71 billion in 2025 to USD 18.61 billion by 2035, at a CAGR of 17.49%. - Key drivers include rising demand for patient-specific implants and prosthetics, increased use of surgical guides and anatomical models, and advances in biocompatible materials. - Major players such as Stratasys, 3D Systems, and Materialise are launching new multi-material and workflow automation technologies to expand clinical applications. - Technologies including selective laser sintering, bioprinting, and AI-powered design software are enabling better patient outcomes at reduced costs and faster treatment times.
- Johnson & Johnson is acquiring Atraverse Medical to add a transseptal access portfolio for minimally invasive cardiac procedures to its MedTech division. - The company has entered a partnership with Viz.ai to integrate AI-based neurovascular imaging into its existing brain health solutions. - These strategic moves strengthen J&J's position in cardiovascular and neurovascular care, aligning with industry trends toward less invasive treatments and AI-driven clinical support. - The acquisitions complement J&J's existing cardiac platforms including Abiomed, Shockwave, and CARTO electrophysiology systems.
- PROMISE III trial demonstrates that transcatheter arterialization of deep veins (TADV) significantly improves quality of life measures in chronic limb-threatening ischemia patients with no other treatment options. - Six months after TADV, patients reported substantial reductions in circulation concerns (90% to 45%), sleep problems (85% to 40%), and daily wound burden (79% to 39%). - The procedure achieved 81% amputation-free survival at 6 months and 86.5% limb salvage rate, offering hope for patients previously facing amputation. - Pain scores decreased significantly from a median of 6 to 2 on a 0-10 scale, while 80% of patients showed healed or healing wounds at 6 months.
- Stryker announced the limited market release of Mako RPS, a handheld robotic system for total knee replacement that combines robotics with familiar power tool functionality. - The FDA-cleared device features intraoperative planning and robotically enabled saw technology with active adjustment capabilities that respond to surgeon hand movements. - Mako RPS targets surgeons who prefer manual procedures over traditional robotic-arm systems, with particular interest from outpatient facilities and ambulatory surgery centers. - The system is compatible with Stryker's Triathlon Total Knee System and integrates with the company's Q Guidance System platform for comprehensive surgical support.
- TSC Life announced FDA clearance for pediatric use of its Fluido® Compact Fluid Warming System, allowing official marketing to hospitals for pediatric patients in the U.S. and Canada. - The system addresses critical hypothermia risks in pediatric surgery, with the device suitable for newborns weighing as little as 7.7 pounds and offering normothermic flow rates starting at 5ml/min. - Clinical evidence demonstrates that one unit of refrigerated blood or one-liter crystalloid at room temperature can reduce mean body temperature by 0.25°C, reinforcing the need for active fluid warming. - The compact system has been proven globally with over 10,000 units installed worldwide over more than 10 years of market adoption in Europe and other regions.
