This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Valcare Medical a has received approval from the US Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) application to initiate an Early Feasibility Study (EFS) of the AMEND™ Trans-Septal System....
Epredia has received clearance from the U.S. Food and Drug Administration (FDA) for its E1000 Dx Digital Pathology Solution (E1000 Dx). This 510(k) clearance allows the technology to be used clinically in the United States....
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....
