Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US...
Medical Device
Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits
China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the...
Acotec’s Vericor-S2 Coronary Microcatheter Approved by NMPA
Acotec Scientific Holdings Ltd (HKG: 6669) has announced that its Vericor-S2 coronary microcatheter has received...
NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices:...
NAMSA to Acquire WuXi AppTec’s US Medical Device Testing Business
US-based medical device contract research organization (CRO) NAMSA is set to acquire the medical device...
US BIS Imposes Export Controls on Biotech Lab Instruments
The Department of Commerce’s Bureau of Industry and Security (BIS) of the United States last...
Boston Scientific’s FARAPULSE and WATCHMAN FLX Studies Show Positive Results
US major Boston Scientific Corporation (NYSE: BSX) has announced the presentation of positive results from...
Medtronic Secures Exclusive Distribution Rights for Contego’s Neuroguard and Excipio
US-Irish firm Medtronic (NYSE: MDT) has entered into an exclusive distribution agreement with Contego Medical,...
Roche’s VENTANA Kappa and Lambda Dual ISH Test Gains FDA Clearance
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing...
MGI Tech’s DNBSEQ-E25 Receives NMPA License as World’s First Self-Luminescent Sequencer
China-based gene sequencing specialist MGI Tech Co., Ltd has announced that it has received a...
Medtronic’s BrainSense Technologies Win EU, UK CE Mark for Parkinson’s Treatment
US-Irish firm Medtronic (NYSE: MDT) has announced that it has received CE (Conformité Européenne) Mark...
CBC Group’s R-Bridge Healthcare Fund Boosts Mirxes with $40M for Cancer Detection Expansion
CBC Group’s R-Bridge Healthcare Fund has made a significant investment of USD 40 million in...
Johnson & Johnson MedTech’s Dual Energy Catheter Gains CE Mark
US major Johnson & Johnson MedTech has announced that its Dual Energy THERMOCOOL SMARTTOUCH SF...
Roche Gains FDA 510(k) Clearance for Roche Digital Pathology Dx with VENTANA DP 600
Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced an additional 510(k) clearance from the...
Medtronic’s Harmony TPV System Gains CE Mark for Minimally Invasive Heart Valve Treatment
US-Irish firm Medtronic (NYSE: MDT) has announced that its Harmony Transcatheter Pulmonary Valve (TPV) System...
GE Healthcare’s Allia IGS Pulse Receives NMPA Clearance for Launch in China
US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced...
Eyebright Medical’s Loong Crystal PR Receives NMPA Class III Medical Device Approval
China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050) has announced that it has received...
Shengwei Kunteng Raises RMB 200 Million in Series A Financing for POCT Development
China-based Hunan Shengwei Kunteng Biotechnology Co., Ltd has announced that it has raised close to...
Balance Medtech’s Interventional Pulmonary Valve Receives Fast-Track Designation from NMPA
China’s Beijing Balance Medical Technology Co., Ltd. (SHA: 688198) has announced that it has received...
Grand Pharmaceutical Initiates Study on GPN00289 for Liver Cancer Treatment
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the first patient enrollment in...