Medical device company Perfuze reported on Wednesday the receipt of the US Food and Drug Administration's (FDA) Breakthrough Device Designation for its Millipede CIS technology.
According to the company, Millipede CIS is an innovative catheter technology that is designed to remove clots from the brain following an acute ischemic stroke. The technology aims to provide superior clinical outcomes in shorter procedural times, resulting in safe, cost-effective therapy.
The FDA's Breakthrough Device Designation recognises the novelty of the company's Millipede technology and its potential to offer significant advantages over existing alternatives for treatment of acute ischemic stroke. The goal is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and de novo marketing authorisation.
An ischemic stroke occurs when a blood vessel in the brain is blocked by a clot, preventing blood flow. Stroke is the second leading global cause of death and a leading cause of disability, according to the World Health Organization (WHO).
Airiver medical receives FDA approval for central airway stenosis trial
Talphera reaches enrollment milestone in NEPHRO CRRT pivotal trial
QT Imaging signs exclusive USD33m distribution deal with Gulf Medical in Saudi Arabia
Novocure submits FDA PMA for Tumor Treating Fields therapy in pancreatic cancer
Covalon Technologies secures DTC eligibility to expand US investor access
Navamedic ASA secures final approvals for Flexilev in OraFID across Nordic markets
Oncopeptides partners with SD Pharma to expand Pepaxti access in Spain
Aptar launches bio-based nasal spray pump with Haleon's Otrivin brand
PharmaJet signs MOU with Egyptian UPA and EVA Pharma to introduce needle-free vaccine delivery
Alcon to acquire LumiThera and its FDA-authorised photobiomodulation device for dry AMD treatment
Predictmedix AI launches mobile diabetes screening platform in India
Navamedic's medical device OraFID approved as primary package for a pharmaceutical product
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions