Search results for "FDA clearance"

Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access

Beyond FDA Clearance: 'MedTech Insight 2026' Navigates U.S. Hospital Procurement and Global Market Access

Securing regulatory clearance for a medical device in overseas markets is a major milestone, but it does not guarantee supply contracts with foreign...
Roen Surgical’s Kidney Stone Robot Zamenix Secures US FDA Clearance

Roen Surgical’s Kidney Stone Robot Zamenix Secures US FDA Clearance

Zamenix, a kidney stone surgery robot developed by medical robotics company Roen Surgical, has received Class II clearance from the U. S.
SK Biopharm Receives FDA Approval for Clinical Trial Plan of Alpha-emitting Radiopharmaceuticals

SK Biopharm Receives FDA Approval for Clinical Trial Plan of Alpha-emitting Radiopharmaceuticals

SK Biopharm announced on the 12th that it has received approval from the U.S. Food and Drug Administration for the...
VOYXACT Preserves Kidney Function for Two Years in Phase 3 IgA Nephropathy Trial

VOYXACT Preserves Kidney Function for Two Years in Phase 3 IgA Nephropathy Trial

Otsuka Pharmaceutical’s VOYXACT (active ingredient: sibeprenlimab) demonstrated long-term kidney protection by...
Samsung Medical Center Adopts Next-Generation Da Vinci 5 Robot to Advance Lung and Esophageal Cancer Surgery

Samsung Medical Center Adopts Next-Generation Da Vinci 5 Robot to Advance Lung and Esophageal Cancer Surgery

Samsung Medical Center has introduced the latest robot-assisted surgery platform, the Da Vinci 5, for lung and...
Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical Cuts Off Hospital Sales After Domestic Nabota Vials Surface in the U.S.

Daewoong Pharmaceutical announced on July 23 that it has severed supply transactions with a domestic medical...
Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

Anchoring the U.S. Supply Chain: GC Green Cross Expands 30-Year Cytiva Partnership to Secure Alyglo Production

GC Green Cross has secured priority access to critical manufacturing consumables to stabilize the production of Alyglo,...
MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

MediPost Begins Pivotal U.S. Phase 3 Trial for Regenerative Knee Therapy Cartistem

South Korean biotechnology company MediPost has entered full-scale Phase 3 clinical testing in the United States for...
Celltrion Advances Next-Generation Immuno-Oncology Candidate with Strong Preclinical Results

Celltrion Advances Next-Generation Immuno-Oncology Candidate with Strong Preclinical Results

Celltrion has announced promising preclinical data for its investigational immuno-oncology candidate, CT-P72/ABP-102,...
Expanded Health Insurance Coverage Lowers Barrier to Care for Rare Heart and Kidney Disorder

Expanded Health Insurance Coverage Lowers Barrier to Care for Rare Heart and Kidney Disorder

Patients suffering from light-chain amyloidosis, a rare and debilitating blood disorder that causes abnormal proteins...