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'김갑성' 기자의 전체기사

iotaMotion Receives FDA Clearance for Expanded Pediatric Us…

ST. PAUL, Minn., Jan. 14, 2026 -- iotaMotion, Inc., creator of iotaSOFT®, the first and only FDA cleared robotic-assisted cochlear implant insertion system, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded pediatric use of its iotaSOFT® Insertion System. The system is now cleared for use in patients four years of age and older, extending access to robotic-assisted cochlear implantation for school-aged children. "Receiving FDA clearance for expanded pediatric use marks a significant milestone for iotaMotion and for families navi
- 김갑성 기자
- 2026-01-14 21:03
Lynx Analytics Introduces Lumen, an Agentic AI Framework to…

LOS GATOS, Calif., Jan. 14, 2026 -- Lynx Analytics today announced Lumen, a specialized Agentic AI framework designed to help pharmaceutical and biotech organizations generate strategic, decision-ready insights from complex scientific and commercial information. Built specifically for life sciences workflows, Lumen enables companies to deploy AI agents across a wide range of real-world use cases — from rapidly distilling lengthy clinical or market research documents, to generating dynamic HCP personas and personalized engagement strategies, to powering natural-lan
- 김갑성 기자
- 2026-01-14 21:00
Head-to-Head Real-World Data: Cadonilimab Outperforms PD-…

HONG KONG, Jan. 14, 2026 -- Akeso, Inc. (9926.HK) announced the presentation of a real-world study at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), comparing cadonilimab plus chemotherapy against a PD-1 inhibitor plus chemotherapy for the first-line (1L) treatment for advanced gastric (G) or gastroesophageal junction (GEJ) cancer with PD-L1 CPS <5 (a propensity-matched, retrospective cohort study). The study results showed that the cadonilimab regimen, compared to the PD-1 monoclonal antibody regimen, significantly prolonged patients' o
- 김갑성 기자
- 2026-01-14 11:54
Enhanced Genetype colorectal cancer risk test released -…

MELBOURNE, Australia, Jan. 14, 2026 -- Rhythm Biosciences Ltd ('RHY', the 'Company' or the 'Group') (ASX: RHY), a transformative, predictive cancer diagnostics technology company is pleased to announce the commercial launch of its updated geneTypeTM Colorectal Cancer (CRC) Risk Assessment clinical test ("geneTypeTM CRC"), a significant advancement in personalised cancer risk prediction. The updated test incorporates additional clinical and lifestyle risk factors alongside the established 140-SNP polygenic risk score (PRS), delivering improved predictive accuracy across both
- 김갑성 기자
- 2026-01-14 11:40
Celltrion presents innovative drug pipeline and U.S. manufac…

Celltrion outlines a blueprint for innovative drug development built on its antibody expertise The company highlights its business strategy to scale U.S. manufacturing and R&D capabilities, strengthening its global supply chain, production and operations INCHEON, South Korea, Jan. 14, 2026 -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today presented key strategic priorities and clinical development updates for its innovative drug pipelines including antibody-drug conjugates (ADCs) and multi-specific antibodies (msAbs) at the 44th Annual
- 김갑성 기자
- 2026-01-14 09:18
Teoxane to Launch First APAC Regional Academy in Bangko…

New hub strengthens Teoxane's commitment to scientific education and clinical partnerships across Asia-Pacific GENEVA, Jan. 14, 2026 -- Teoxane opens its first APAC Regional Academy in Bangkok, Thailand this January, expanding its global medical-education network. Located on Level 12 of One Bangkok Tower 4, the hub offers a modern environment designed to support high-quality clinical training. Purpose-built as a regional center of excellence, the Academy will upskill licensed aesthetic practitioners through science-based education, hands-on technique, and expert
- 김갑성 기자
- 2026-01-14 08:15
DNV SUPPORTS NOUL IN IVDR CERTIFICATION FOR AI-BASED MEDICAL DIAGN…

SEOUL, South Korea, Jan. 14, 2026 -- DNV, the independent global assurance and risk management provider, is partnering with Korean AI-driven blood and cancer diagnostics company Noul to certify their malaria diagnosis, blood cell morphology and cervical cancer testing solutions, under the European Union's In Vitro Diagnostic Medical Device Regulation (IVDR). The EU's IVDR provides a regulatory basis for establishing the safety and effectiveness of new in-vitro diagnostic (IVD) devices. Most IVD devices require a certificate of compliance with the IVDR to receive a CE
- 김갑성 기자
- 2026-01-14 08:00
DNV, 노을(Noul)의 AI 기반 체외진단의료기기 대한 EU IVDR 인증 심사 진행

서울, 대한민국 2026년 1월 14일 -- 글로벌 인증기관(Notified Body, NB)인 DNV가 AI 기반 혈액 및 암 진단 플랫폼 기업 '노을(Noul)'의 주요 제품군에 대해 유럽연합(EU)의 체외진단의료기기 규정(IVDR)에 따른 인증 심사를 진행한다고 밝혔다. 이번 심사 대상은 노을의 혁신적인 miLab™ 플랫폼을 기반으로 하는 말라리아 진단용 miLab™ MAL 카트리지, 혈구 형태 검사용 miLab™ BCM 카트리지, 자궁경부암 검사용 miLab™ CER 카트리지 등 총 세 가지 솔루션이다. 노을의 miLab™ 플랫폼을 기반으로 하는 이 솔루션들은 통합 시료 전처리부터 디지털 이미징, AI 분석 기능을 단일 기기에 결합한 것이 특징이다. 이러한 기술적 결합을 통해 확보한 뛰어난 휴대성은 도심의 최첨단 병원뿐만 아니라 의료 인프라가 제대로 구비되지 않은 아프리카 등 오지의 시골 진료소에 이르기까지, 장소에 구애받지 않고 전 세계 모든 의료 환경에서 일관된 고품질 검사와 효율적인 워크플로우를 가능하게 한다. EU의 IVDR은 체외진단의료기기(IVD)의 안전성과 유효성을 철저히 검증하기 위
- 김갑성 기자
- 2026-01-14 08:00
Rakuten Medical and LOTTE Biologics Sign Manufacturing A…

SEOUL, South Korea, Jan. 14, 2026 -- Rakuten Medical, Inc. and LOTTE Biologics today announced that they have signed a biopharmaceutical contract manufacturing agreement during the J.P. Morgan Healthcare Conference in San Francisco to strengthen Rakuten Medical's production capabilities for its innovative oncology therapy, Alluminox® platform-based photoimmunotherapy. Under the agreement, LOTTE Biologics will provide advanced manufacturing services for monoclonal antibody intermediates and their conjugates, supporting Rakuten Medical's global clinical development an
- 김갑성 기자
- 2026-01-14 07:34
Firstsource Acquires TeleMedik To Bolster Digital Offerings a…

MUMBAI, India and DALLAS, Jan. 14, 2026 -- Firstsource Solutions Limited (NSE: FSL) (BSE: 532809), a leading global provider of business management services and an RP-Sanjiv Goenka Group company, today announced the acquisition of TeleMedik, a Puerto Rico based pioneer in the development and implementation of technological solutions. The acquisition significantly strengthens Firstsource's end-to-end clinical and utilization management capabilities, expands its footprint across payer-provider networks, and further enriches the company's fully integrated and differentiated Business Proc
- 김갑성 기자
- 2026-01-14 03:19

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발행인 : 최희정 | 편집인 : 김갑성 |
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