Part of Medtronic, Inc.
Clinical Trials
56
11 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
10
17.9%
Completed
29
51.8%
Enrolling By Invitation
1
1.8%
Recruiting
7
12.5%
Terminated
3
5.4%
Unknown
2
3.6%
Withdrawn
4
7.1%
No approval data available
- Medtronic received FDA clearance for the LigaSure RAS Maryland jaw device, the first robotically driven LigaSure instrument, for use with its Hugo robotic-assisted surgery system. - The instrument seals and cuts vessels, thick tissue and lymphatics up to 7 mm in diameter, sealing vessels in about 2 seconds while limiting thermal spread. - The clearance brings to the U.S. a capability already available in Europe, where Medtronic obtained CE mark for the robotic vessel-sealing technology in 2025. - Hugo is currently cleared in the U.S. for urologic procedures, with 510(k) filings pending for general and gynecologic surgery indications.
- Immunic, Inc. has appointed Chitrang Davé as its newly created Chief Data and Digital Officer, effective September 1, 2026, reporting directly to CEO Erik Lundgren. - The role will establish enterprise-wide data, analytics, AI, and digital capabilities to support the potential NDA submission and commercialization of vidofludimus calcium (IMU-838) in multiple sclerosis. - Top-line data from the Phase 3 ENSURE trials in relapsing MS are expected by year-end 2026, with a confirmatory Phase 3 program in progressive MS advancing. - Davé brings more than 25 years of data and analytics leadership experience from Avidity Biosciences, Edwards Lifesciences, and Medtronic.
- 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.
- Medtronic is approaching a technical breakout as its diabetes-focused spinoff, MiniMed, reaches a record high, according to Investor's Business Daily. - The stock movement reflects investor interest in Medtronic's restructuring and the separation of its diabetes care business into MiniMed. - The report frames the development within technical trading analysis rather than new clinical or regulatory data. - No new efficacy, safety, or trial data are presented in the source material.
- Amgen filed an 8-K with the SEC on July 31, 2026, confirming attackers exfiltrated patient PHI, proprietary data, and R&D information from third-party cloud environments. - The breach is linked to the ShinyHunters threat group, which had targeted Amgen as early as January 2026 and uses SSO vishing to compromise vendor helpdesks. - Under HIPAA, the 60-day patient notification clock may have started from the vendor's discovery date, not Amgen's; no patient notification timeline has been announced. - Healthcare records command up to $250 each on dark web markets, and stolen PHI enables highly targeted social engineering against patients.
- Venus Medtech has completed patient enrollment in the PREVAILS study, a pivotal confirmatory trial for the Venus-PowerX transcatheter aortic valve system in patients with severe aortic stenosis. - Venus-PowerX is the world's first self-expanding dry-valve TAVR device capable of full retrieval even after 100% deployment, with real-world data already emerging from Argentina, Chile, and Venezuela. - Data from the single-arm, objective-performance-criterion trial will support simultaneous regulatory submissions to China's NMPA and for CE marking in Europe under the stricter EU MDR 2017/745 framework. - The device enters a market dominated by Edwards Lifesciences ($4.5 billion in 2025 TAVR sales, over 60% share), with differentiation hinging on whether the retrieval mechanism translates into measurable clinical safety advantages.
- Linking individual-level randomized clinical trial data with real-world data enables extended follow-up, capture of outcomes not collected in trials, and accelerated real-world evidence generation without additional participant burden. - Deterministic linkage remains the most commonly published method, while privacy-preserving record linkage and tokenization are gaining traction but remain underrepresented in published RCT linkage projects. - Four case studies spanning vaccines, RSV, and transcatheter aortic valve replacement demonstrate that linkage can reproduce randomized treatment effects and assess transportability, though linkage rates vary widely by payer infrastructure. - Successful RCT–RWD linkage requires prospective alignment of decision context, quantitative reporting of linkage performance, traceable governance documentation, and operational planning integrated into trial design.
- The global ENT devices market was valued at USD 24.89 billion in 2025 and is projected to reach USD 44.91 billion by 2035, growing at a CAGR of 6.08%. - Hearing aids remain the largest product segment at approximately 32.40% share, while surgical ENT devices are the fastest-growing at roughly 6.52% CAGR. - North America held the largest regional share at approximately 37.60% in 2025, with Asia-Pacific emerging as the fastest-growing region at about 6.59% CAGR. - FDA over-the-counter hearing aid reform is expected to make an estimated 28 to 38 million Americans with untreated mild-to-moderate hearing loss newly reachable through consumer channels.
- 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.
