This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
CGBIO has received Investigational Device Exemption approval from the US Food and Drug Administration for its bone graft substitute, NOVOSIS PUTTY. This approval allows the company to begin clinical trials in spinal fusion procedures in the United States....
Proprio has received its second 510(k) clearance from the FDA for its surgical guidance platform, Paradigm. This new clearance allows the inclusion of intraoperative measurements, making Paradigm...
Innoblative Designs has received Investigational Device Exemption approval from the U.S. Food and Drug Administration. This regulatory milestone allows the company to begin a feasibility study in the United States to assess the safety and effectiveness of its SIRA®...
Anuncia Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its ReFlow® EVD. This device is designed to improve external ventricular drains (EVDs), which are used to manage brain...
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...
