MedTech News
.................... by Andrew Celentano
ZEISS CLINIC 360 receives FDA 510k clearance, amplifying patient care through simplified clinical insights
The ZEISS CLINIC 360 all-in-one browser-based software solution aggregates clinical data at scale and powers advanced analytics for streamlined ophthalmic workflows, providing clinicians with more time for personalizing patient care.
Enveda’s exercise-simulating obesity tablet clears early clinical test
Touting an “exceptional” gastrointestinal safety profile for its oral obesity drug candidate in a study of healthy volunteers, Enveda plans to test the asset in people stopping GLP-1 treatment.
Cell-preservation technique could make CAR-T cell therapy more accessible
MIT researchers’ approach, which uses naturally occurring sugars as antifreeze, could make it easier for hospitals to deploy this type of cancer treatment.
FDA clears Empatica’s platform for Parkinson’s monitoring
Empatica’s platform enables continuous tracking of symptoms such as bradykinesia, dyskinesia and sleep quality.
Masimo’s brain function monitor secures CE mark
The approval covers smartSedLine monitor availability in applicable European markets.
NORROY BIOSCIENCE Granted FDA Breakthrough Therapy and Fast Track Designations for Kidney Cancer Imaging Product
WUXI, China, Aug. 19, 2026 /PRNewswire/ — NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY’s 68Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (ccRCC).
Empatica Receives FDA Clearance for Parkinson’s Monitoring
BOSTON, Aug. 19, 2026 /PRNewswire/ — Empatica, a leader in digital biomarker development and clinical-grade wearable technology, today announced that the Empatica Health Monitoring Platform for Parkinson’s has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Doctors may now see the hidden signs of sudden cardiac death
Each year, roughly 2% to 5% of the population is affected by mitral valve prolapse (MVP) and mitral regurgitation (MR). These conditions can affect the heart’s rhythm and have been linked to sudden cardiac death, particularly in advanced stages of the disease, through the development of abnormal electrical activity. MVP causes the valve to bend backward as the heart contracts, while MR affects the valve’s ability to close fully, leading to blood leaking backward.