NovaXS Biotech announced that it unveiled the new prototype for its needle-free injection therapy smart medical device. Formed at the University of California, Berkeley, NovaXS designed its patent-pending Telosis technology to administer a narrow stream of medication without a needle in 0.3 seconds and to analyze injection data to allow for smarter health decisions. Get […]
SpineX enrolls first patient in spinal neuromodulation technology trial
SpineX announced today that it enrolled the first patient in its pivotal trial evaluating the Scone neuromodulation device. Los Angeles-based SpineX will evaluate the safety and effectiveness of the non-invasive spinal neuromodulation technology for the treatment of neurogenic bladder. The first patient was enrolled at the Rancho Research Institute of the Rancho Los Amigos National […]
GE Healthcare’s Carescape ventilator battery recall is Class I
The FDA issued a notice today labeling the recall of GE Healthcare’s (NYSE:GE) Carescape R860 ventilator as Class I, the most serious kind. GE Healthcare recalled the Carescape R860 ventilator backup batteries, including replacement backup batteries, because the batteries may run out before they are expected to do so. If the ventilator is running on […]
Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon
Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. Get the full story at our sister site, Drug […]
Centerline Biomedical raises $33M Series B
Centerline Biomedical announced that it closed a $33 million Series B equity financing, led by Cleveland Clinic. GE Healthcare, RIK Enterprises, JobsOhio, Jumpstart Ventures and G2 Group Ventures all participated in the financing, which will be used to help propel the Cleveland-based company into new surgical applications, accelerate its commercial sales and add to its […]
Memic completes first robotic-assisted transvaginal hysterectomy procedures with Hominis
Memic Innovative Surgery announced today that the first U.S. patient procedures were completed with its Hominis system for robotic-assisted transvaginal hysterectomy. HCA Florida Kendall Hospital and The Women’s Hospital at Jackson Memorial successfully completed the first U.S. patient procedures using Hominis, the first and only FDA-authorized surgical robot that features miniature humanoid-shaped arms, with shoulder, […]
‘Multiple disruptions’ slow timeline for Titan Medical’s Enos robotic surgery platform
Titan Medical (Nasdaq:TMDI) announced today that it updated the FDA submission timeline for its Enos robotic surgery platform. “Multiple disruptions” have resulted in an updated FDA investigational device exemption (IDE) submission timeline for the Enos robotic single access surgery system, with the Toronto-based company now expecting the IDE submission to come in mid-2023, rather than […]
Philips updates on testing results for recalled ventilators
Royal Philips (NYSE:PHG) says only a small portion of returned respiratory devices displayed the sound abatement foam degradation that sparked a massive recall. Repeated ozone cleaning may have made the problem worse. Those were some of the major takeaways from an update Philips provided today on a comprehensive test and research program it implemented after […]
Varian wins FDA IDE for Flash radiation therapy
Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical research program. Flash therapy, an experimental treatment modality, was designed to deliver radiation therapy at ultra-high dose rates in typically less than one second. The Siemens Healthineers company will conduct the feasibility study of Flash therapy for the treatment […]
Virpax to pursue over-the-counter pathway for topical spray treatment for osteoarthritis pain
Virpax Pharmaceuticals (Nasdaq:VRPX) announced today that it will pursue a direct to over-the-counter (OTC) regular pathway for Epoladerm. Berwyn, Pennsylvania–based Virpax designed the Epoladerm investigational pre-filled topical spray analgesic product for the non-addictive management of chronic pain associated with osteoarthritis (OA) of the knee. Get the full story at our sister site, Drug Delivery Business News.
Inovio names new chief medical officer
Inovio (Nasdaq:INO) announced today that it appointed Dr. Michael Sumner as its new chief medical officer (CMO). Sumner will oversee Inovio’s clinical-stage pipeline of DNA medicines, global clinical development, clinical operations and biostatistics efforts, along with regulatory affairs, pharmacovigilance and medical affairs. He will also serve on the company’s executive leadership team and report to President […]
