Regulatory Approvals

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

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, 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 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...

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...

AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnoea (OSA) in adults, has obtained FDA 510(k)...

Respira Labs recently announced that it has developed a wearable device that continuously assesses lung function without the need for traditional pulmonary function tests. Mountain...

The InVisionOS officially received the clearance earlier this month and will be available in early 2022. PrecisionOS scored FDA 510(k) clearance for its InVisionOS tool that...