Abk Biomedical Inc. has completed an oversubscribed $30 million series C funding round to support IDE approval for Eye90 microspheres designed to improve outcomes for patients with liver cancer. The departure point for the technology’s development is U.S. FDA-cleared Y90 technology such as Boston Scientific’s Therasphere and Sir-Spheres developed by Sydney, Australia-based Sirtex Medical Ltd. “They are the only radioembolization microspheres on the market and that is the clinical space in which we will be submitting our IDE application,” Abk chief business officer Gary Donofrio told BioWorld. “Hopefully we’ll get approvals for the pivotal study and eventually to market in that space. It’s going to be great to be able to innovate and improve on what’s already been done there.”
Seven new U.S. medtechs are poised to make a splash in the diagnosis and treatment of nervous system disorders thanks to funding under a new program within the National Institutes of Health (NIH) Blueprint for Neuroscience Research called Blueprint Medtech.
Mainstay Medical Holdings plc released data from a one-year, real-world, study of patients implanted with a neurostimulation device to treat chronic lower back pain.
Ricoh USA Inc. recently received U.S. FDA clearance for craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling technology, using 3D printing technology developed by Eden Prairie, Minn.-based Stratasys Inc. for patient-specific representations of tissue and bone. The Ricoh 3D for Healthcare platform is described as an end-to-end workflow solution for designing and producing 3D-printed anatomic models for the mouth, jaws, face, skull and other CMF structures.
Uromems SAS reported the successful completion of the first-in-human implant of a smart, automated artificial urinary sphincter (AUS) device for treating stress urinary incontinence (SUI). This initial pilot study recently saw the first male patient implanted with the Uroactive System at Paris’s La Pitié-Salpêtrière University Hospital and is considered by the company to be a key milestone in the technology’s development.
Endologix LLC reported 12-month results from the second of two studies of a fully percutaneous, transmural arterial bypass therapy for treating peripheral arterial disease. Presented at this month's annual Vascular Interventional Advances Conference in Las Vegas, the Detour-2 study revealed technical success in 100% of treated patients using the system which also surpassed a 30-day, major adverse event rate of just 7%.”
Rapidai Inc. received U.S. FDA 510(k) clearance for release of intracranial hemorrhage (ICH) triage technology that reduces notification fatigue in doctors swamped by calls to treat hemorrhages that turn out to be false positives. In a test sample sent to the regulatory agency, the artificial intelligence (AI)-powered system demonstrated a sensitivity rating of 97% detecting genuine hemorrhages and 100% specificity for a false positive rate of zero.
Cardiai Inc. has developed a small, portable monitor that continuously measures patients’ blood pressure (BP) at regular intervals for up to seven days, well beyond the single measurements historically done in a doctor’s office.
Argá Medtech SA said patients in the first stage of enrollment for a first-in-human clinical trial have been safely and effectively treated with an ablation system for treating atrial fibrillation (AF). The Coherent Sine Burst Electroporation (CSE) system uses a pulsed field ablation (PFA) sine waveform and single, configurable (circular, linear, and focal) ablation catheter to better treat patients suffering from AF.
GE Healthcare has introduced an all-digital PET/CT System featuring a new category of digital BGO (crystal-based gamma ray detection) employing a smaller crystal size to deliver greater spatial resolution than other digital scanners. Pitched at the European Association of Nuclear Medicine’s annual meeting in Barcelona on Oct. 16, Omni Legend was designed to accelerate scan times and has demonstrated, according to GE Healthcare global chief marketing officer Sonia Sahney, “impressive small lesion detectability.”
