隶属于 xsensio sa
相关临床试验
3258
324 进行中
药物批准
8
批准总数
监管机构
1
监管机构数
成立时间
1889
Unknown
13
0.4%
已完成
1913
58.7%
Enrolling By Invitation
103
3.2%
尚未招募
62
1.9%
No Longer Available
4
0.1%
终止
299
9.2%
招募中
508
15.6%
暂停
17
0.5%
Approved For Marketing
1
0.0%
撤回
179
5.5%
进行中（未招募）
159
4.9%
- More than 90 lawsuits have been filed in New Jersey state court against Novo Nordisk on behalf of patients who developed NAION after taking Ozempic or Wegovy. - The European Medicines Agency concluded in June 2025 that NAION is a very rare side effect of semaglutide, while the FDA continues investigating without requiring a US label warning. - Denmark has paid more than $1.5 million to 27 patients who developed vision loss after Ozempic or Wegovy, with 38 additional cases still under review. - Evidence on causality remains mixed, with studies reporting risk increases from roughly two-fold to nearly eight-fold while a Novo Nordisk-supported study found no increased risk.
- CorTec received a second FDA Breakthrough Device Designation for its Brain Interchange brain-computer interface, this time covering communication for people with non-progressive quadriplegia. - The designation covers use of the implantable BCI to let people with paralysis in all four limbs control a computer cursor through neural signals. - The first designation, granted in April 2026, covered stroke motor rehabilitation, which remains CorTec's lead clinical program in an IDE study at the University of Washington.
- Bayesian Health's FDA-cleared continuous sepsis monitor received a New Technology Add-on Payment (NTAP) under CMS's FY 2027 Inpatient Prospective Payment System Final Rule. - Beginning October 1, 2026, hospitals can receive up to $61.84 per eligible case across an estimated 739 MS-DRGs, making it the first reimbursement pathway for presuspicion sepsis monitoring. - The approval builds on FDA clearance in April 2026 and a Nature Medicine study showing an 18.2% mortality reduction and antibiotics delivered a median of 1.85 hours sooner. - Sepsis claims 270,000 US hospital lives annually and drives over $50 billion in yearly costs, with each hour of delayed treatment reducing survival by up to 7.6%.
- Optiscan Imaging has initiated a 35-patient US head and neck cancer imaging study at Mayo Clinic Rochester, with patient recruitment now underway. - The study will evaluate the InVue™ and InForm™ platforms for assessing surgical margins during head and neck tumour resections across in vivo and ex vivo settings. - Resulting data are intended to support Optiscan's planned US FDA regulatory submissions for both platforms later in 2026. - Head and neck cancer is the seventh most common cancer globally, with roughly 890,000 new cases and 450,000 deaths annually, and up to 50% of patients experience recurrence.
- NeuroOne received ISO 13485 certification, enabling international commercialization of its OneRF Brain and Trigeminal Neuralgia Ablation Systems and Evo diagnostic lines. - Third-quarter fiscal 2026 product revenue reached $2.0 million, up 16% year over year, with product orders of $2.7 million, up 43%. - The Journal of Neurosurgery published a Mayo Clinic Jacksonville study showing OneRF procedures may be performed without interfering with implanted neuromodulation hardware. - NeuroOne's robotic-assisted StereoCED intracranial drug delivery platform is expected to be ready for investigational human clinical studies by the end of September.
- The FDA authorized Vitestro's Aletta, the first standalone robotic device that draws blood from a patient's arm without hands-on operator intervention. - Aletta uses near-infrared light, Doppler ultrasound, robotics, and AI to locate veins, insert the needle, and complete the blood draw autonomously. - One phlebotomist can oversee up to three Aletta devices, which may help address the growing shortage of trained phlebotomists in the U.S. - Clinical data showed successful blood draw rates comparable to or better than trained human phlebotomists, with device-related adverse events uncommon and mild.
- An international Mayo Clinic-led study published in JAMA Neurology found IL-6 receptor blockers tocilizumab and satralizumab substantially reduced relapses in MOGAD patients. - The observational study evaluated 116 patients across multiple centers in North and South America, making it the largest real-world evaluation of IL-6 receptor blockade in MOGAD to date. - No therapies are currently approved specifically for preventing MOGAD relapses, and these findings offer guidance while randomized clinical trials remain underway. - The medications demonstrated a generally favorable safety profile, though infections remain an important consideration for clinicians managing treatment.
- The FDA granted accelerated approval in August 2026 to an iberdomide-based regimen for relapsed multiple myeloma, marking the first time MRD-negative complete response entered regulatory decision-making. - Anti-CD38-based quadruplet regimens (Dara-VRd and Isa-VRd) now anchor frontline therapy, with 4-year PFS of 84% versus 68% for VRd in the PERSEUS trial. - CAR-T and bispecific antibodies have moved into early relapse, with MajesTEC-3 showing 3-year PFS of 83.4% versus 29.7% for teclistamab-daratumumab over standard daratumumab-based regimens. - The AQUILA trial established daratumumab as the first approved therapy for high-risk smoldering myeloma, improving 5-year PFS from 40.8% to 63.1%.
- Transcripta Bio has raised $24 million since its Series A to advance IND-enabling studies across its four-program pipeline targeting neurological and neuromuscular diseases. - Mayo Clinic and Omnimed join existing investors JAZZ Venture Partners, BlueYard Capital, and life sciences family offices as the company prepares for human clinical trials. - The company's closed-loop discovery engine uses transcriptomic signature matching with a machine learning system trained on over one billion gene responses to de-risk drug development. - Pipeline programs span Myotonic Dystrophy, Facioscapulohumeral Muscular Dystrophy (FSHD), Autism Spectrum Disorder (ASD), and Huntington's Disease (HD), with clinical preparation underway in ASD and FSHD.
- Traci Tamiko Eto, former Mayo Clinic Director of Research Operations, filed a federal lawsuit alleging she was fired after flagging serious AI safety violations including data manipulation and patient privacy breaches. - The lawsuit claims researchers on Mayo's MAYA digital assistant concealed a 67% error rate by deleting unfavorable results, with 10 internal whistleblower reports raising similar alarms. - Eto alleges she uncovered unauthorized AI deployment in clinical workflows, unapproved cardiac surgery using an investigational device abroad, and improper genome data sharing without patient consent. - Mayo Clinic stated it is "committed to the responsible development and deployment of AI" but has not yet filed a formal response to the lawsuit, which seeks damages and a jury trial.
