Regulatory Approvals

Glaukos Announces FDA 510(k) Clearance of iPRIME™

Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal...

Endotronix announces FDA approval for PROACTIVE-HF pivotal trial design change

Endotronix has announced that the US Food and Drug Administration (FDA) has granted approval for an amendment to the company’s PROACTIVE-HF study, a pivotal...

Manus receives FDA Breakthrough Designation for NMP device

Manus Neurodynamica, which develops and markets products and technologies for neuromotor assessment, has been granted Breakthrough Designation by the U.S. Food and Drug Administration (FDA) for...

Implicity receives FDA clearance for AI-Powered ECG analyser

Implicity has announced US Food and Drug Administration (FDA) clearance for a novel medical algorithm that analyses ECG data from implantable loop recorders (ILRs). “This...

ClaroNav Kolahi Receives Chinese Regulatory Clearance for Navient Neuro-navigation System

ClaroNav Kolahi Inc, a subsidiary of ClaroNav Inc, has received Chinese regulatory clearance from the National Medical Products Administration (NMPA) to market and sell its...

Intuitive Secures FDA Clearance for 8 mm SureForm 30 Curved-Tip Stapler

Intuitive (Nasdaq: ISRG) has today announced that the U.S. Food & Drug Administration (FDA) cleared the company’s fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads...

Immunexpress’ rapid sepsis test receives FDA clearance

Immunexpress, a molecular diagnostic company focussed on improving outcomes for suspected sepsis patients, has received 510(k) clearance from the U.S. Food and Drug Administration...

Cork-based Gasgon Medical wins Seedcorn Investor prize

Cork-based medtech firm Gasgon Medical has been named the overall winner of the InterTradeIreland Seedcorn Investor Readiness Competition, pocketing a cash prize of €100,000. Press...

Sound Life Sciences scores FDA 510(k) for smart device respiratory monitoring app

The prescription app uses a smartphone or smart speaker to measure breathing. Sound Life Sciences scored FDA 510(k) clearance for its prescription app that uses...
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