相关临床试验
36
7 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）
4
11.1%
已完成
22
61.1%
尚未招募
3
8.3%
招募中
3
8.3%
撤回
4
11.1%
暂无批准数据
- Jaguar LAA, Inc. has acquired assets related to the Laminar program from Johnson & Johnson, which is exiting the left atrial appendage closure market. - The Laminar program uses a catheter-based approach with rotational motion to close and eliminate the LAA while leaving minimal device exposure in the left atrium. - Jaguar was formed in partnership with Santé Ventures and members of the Laminar management team, with Santé leading company formation and financing. - The program still faces development and regulatory review, with the timeline to a US approval bid not yet set and financial terms undisclosed.
- 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.
- Aqua Medical treated its first West Coast patient (second overall in the U.S.) in the FDA-approved IDE RESTORE-I trial of its investigational PIMA procedure for type 2 diabetes. - The procedure was performed at Hoag Hospital by Dr. Jennifer Phan, who becomes the first woman interventional endoscopist in the U.S. to perform PIMA. - Aqua Medical named Bob Haggerty as CEO, a veteran who scaled radiofrequency ablation for Barrett's Esophagus into a $40 million business. - The PIMA procedure uses radiofrequency vapor ablation delivered through a standard endoscope, requiring no surgery or fluoroscopy, targeting inadequately controlled type 2 diabetes.
- Boston Scientific's MANDARIN (S6371) trial compares TheraSphere glass bead radioembolization against conventional artery-based chemoembolization in Chinese liver cancer patients who cannot undergo surgery. - The interventional, randomized, parallel-design study with no blinding is now listed as completed, with its most recent update filed on 10 August 2026. - Positive results could strengthen TheraSphere's adoption and pricing power in China and other Asian markets, where interventional oncology competition is intense. - Boston Scientific is also advancing a separate post-approval multicompartment dosimetry study for TheraSphere, currently not yet recruiting.
- The global heart valve devices market was valued at USD 11.87 billion in 2025 and is forecast to reach USD 24.95 billion by 2032, expanding at an 11.2% CAGR. - Transcatheter aortic valve replacement (TAVR) is the strongest adoption signal, with over 80,000 U.S. procedures performed annually in 2023 and projections exceeding 190,000 by 2029. - TAVR procedures demonstrate a 30-day mortality rate of approximately 2–3%, compared with 5–8% for traditional open-heart surgery, reshaping the hospital business case. - Recent regulatory milestones include JenaValve's FDA premarket approval for the Trilogy system and Genesis MedTech's NMPA approval for the J-Valve Transfemoral TAVI System in China.
- 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.
- Late August 2026 saw a coordinated wave of cyberattacks on healthcare and critical infrastructure, disrupting medical care and compromising patient data. - Boston Scientific suffered a major hack that disrupted customer order processing and halted activation of new remote patient monitoring systems. - McKesson faced a breach by the ShinyHunters group, which claimed to have exfiltrated hundreds of millions of patient records and demanded a $55 million ransom. - Experts argue that resilience, not prevention alone, now defines healthcare security, with constant low-level disruptions eroding clinical workflows and patient safety.
- Penumbra received FDA clearance for THUNDERBOLT, the first computer-assisted vacuum thrombectomy (CAVT) platform designed for acute ischemic stroke treatment. - The device introduces modulated aspiration technology that detects, fatigues, and completely ingests clots at the occlusion site, enabling faster and more complete clot removal. - The clearance represents a positive milestone for Boston Scientific, which agreed to acquire Penumbra for approximately $14.5 billion in January 2026. - Analysts estimate THUNDERBOLT could contribute approximately $100 million in incremental revenue to Boston Scientific over time.
- Collate, an AI startup founded by Surbhi Sarna, raised $95 million in Series A funding led by Redpoint Ventures, bringing total funding to $125 million at a valuation approaching $1 billion. - The company's GxP-compliant AI platform automates regulatory documentation and clinical trial paperwork, reporting time savings of 50% to 90% and accuracy rates above 90%, often closer to 97%. - Since signing its first customer in May 2025, Collate has onboarded approximately 50 life sciences customers, including large pharmaceutical companies, medical device manufacturers, and publicly traded biotech firms. - Sarna predicts that within six to nine months, the majority of the world's life sciences companies will adopt AI for documentation workflows, calling the sector the "AI battleground of 2026."
- NinaMED Pty Ltd, a newly formed Australian medical device company, secured $13.75 million in financing led by SPRIM Global Investments to develop the NiNA System®, a non-invasive, at-home therapy for overactive bladder. - The NiNA System® targets the saphenous nerve through wearable neuromodulation technology, offering a drug-free alternative for the estimated 550 million people worldwide affected by overactive bladder. - The company obtained exclusive global licensing rights from Toronto-based EBT Medical and appointed Ian Meredith, former Boston Scientific executive, as Board Chair to lead commercialization efforts. - The financing will accelerate clinical development, support an Investigational Device Exemption application, and build operations in Australia for worldwide commercialization of this novel therapeutic approach.
