This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Shockwave Medical has introduced the Shockwave Javelin Peripheral IVL Catheter in the United States. This innovative intravascular lithotripsy (IVL) platform is designed to modify calcium and navigate through severely narrowed vessels in patients with peripheral artery disease (PAD). ...
Discure Technologies, a clinical-stage medical device company focused on developing treatments for degenerative disc disease and other orthopaedic conditions, has been accepted into the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle (TPLC) Advisory Programme (TAP). ...
ABANZA, a pioneer in advanced soft tissue repair solutions, has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its WasherCap™ Mini fixation system. This innovative device is designed for a range of orthopaedic procedures...
Navi Medical Technologies has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Neonav® ECG Tip Location System. This approval enables its use in hospitals across the United States, improving vascular...
Neuvotion, an early-stage medical device company specialising in AI-driven neuromodulation technologies, has received FDA 510(k) clearance for its first product, NeuStim™. This non-invasive, wearable device provides precise electrical muscle stimulation without the need for surgery...
RapidAI, a global leader in AI-driven medical imaging analysis and coordinated care, has received FDA 510(k) clearance for Lumina 3D™. This is the first automated 3D imaging reconstruction solution designed to replace manual processes...
Beckman Coulter Diagnostics has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Access p-Tau217/β-Amyloid 1-42 plasma ratio test. This blood test is designed to help healthcare professionals identify amyloid pathology associated...
Modella AI, a company specialising in generative and agentic artificial intelligence for biomedicine, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its advanced AI-driven diagnostic tool, PathChat DX....
Alleviant Medical Gains FDA Breakthrough Designation for Heart Failure Technology Alleviant Medical, Inc., a private medical device company specialising in no-implant atrial shunt technology for heart failure, has announced two significant developments from the US Food and Drug Administration (FDA). ...
Simpson Interventions has reached significant development milestones in the field of cardiovascular interventional devices. The company’s innovative Acolyte™ Image-Guided Crossing and Re-Entry Catheter System has been granted an Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA). ...
