Paradromics demonstrated that its brain-computer interface implant could enable real-time speech communication, with its first early study participant able to choose her own words and answer open-ended questions. The woman received a diagnosis of a progressive motor neuron disease about 10 years ago, in a group of conditions that includes amyotrophic lateral sclerosis and primary […]
Clinical Trials
AiM Medical Robotics’ $2M NIH grant and other extra medtech news
AiM Medical Robotics recently received a $2 million Phase II Small Business Innovation Research (SBIR) award from the NIH”s National Cancer Institute to advance its MRI-guided neurosurgery robotics systems. “Receiving this award is significant well beyond the funding; it validates the clinical and business need through a highly rigorous peer review process and it enables […]
Intuitive draws on data from 14M cases to back da Vinci systems
A new comprehensive study of Intuitive Surgical‘s (Nasdaq:ISRG) da Vinci systems found significant improvements in patient outcomes compared to laparoscopic and open surgery. The study analyzed data from more than 14 million da Vinci, laparoscopic and open procedures to treat 13 non-cancerous conditions in gynecology, general surgery, bariatric surgery, urology, and hernia repair. Intuitive’s da […]
Petal Surgical says its first-in-human incisionless surgery is coming soon and offers a first glimpse of its system
Petal Surgical is “moving out of the lab” and toward human trials of its incisionless surgery platform in the near future, the surgical tech startup tells MassDevice. The histotripsy developer is almost finished with its controlled, in-vivo preclinical studies, saying they will yield a first-of-its kind dataset demonstrating “the extent to which [the] platform can […]
Philips says preliminary data backs its ultrasound tech’s mitral regurgitation tracking
Philips (NYSE: PHG) shared new clinical data supporting its AI-powered 3D Auto Color Flow Quantification (CFQ) technology for measuring mitral regurgitation. Mitral regurgitation is a common heart condition in which the mitral valve does not close tightly, allowing blood to leak or flow backward. This can lead to a number of risks for the patient, […]
CVRx earns new Medicare Advantage coverage policy for Barostim
CVRx (Nasdaq: CVRX) earned a new Medicare Advantage coverage policy from Devoted Health for its Barostim therapy, the company announced today. Barostim is an implantable pulse generator that electrically stimulates baroreceptors in the carotid artery to rebalance the nervous system and improve heart failure symptoms. The new policy covers the implant for patients with heart […]
FDA authorizes first-of-its-kind autonomous robotic blood draw device
The FDA granted de novo classification to a standalone robotic device that can draw blood from a patient’s arm without a hands-on operator. Dutch medical robotics company Vitestro developed the autonomous robotic phlebotomy device, called Aletta, to conduct every step of a blood draw, “from placing the tourniquet to applying the bandage,” the company says. […]
Sonorous Neurovascular enrolls first Canadian patient in pulsatile tinnitus study
Sonorous Neurovascular, a medical device company focused on solutions for cerebral venous diseases and neurovascular interventions, today announced the first patient enrollment in Canada under its international B-SILENT study. The enrollment took place at The Ottawa Hospital under principal investigator Dr. Robert Fahed. The B-SILENT study is evaluating the investigational use of the BosSTENT, Sonorous’ braided, self-expanding […]
Adagio treats first patient with next-gen low-temp ablation system
Adagio Medical (Nasdaq:ADGM) today announced the successful treatment of the first patient with its next-generation vCLAS technology. The treatment took place under the FDA’s Expanded Access authorization. It utilized the company’s Ultra Ultra-Low Temperature Ablation (ULTA) system. Laguna Hills, California-based Adagio said the patient presented with non-ischemic cardiomyopathy and a recent history of failed radiofrequency (RF) […]
enVVeno Medical wins FDA IDE for non-surgical transcatheter replacement venous valve
enVVeno Medical (Nasdaq:NVNO) announced today that it received FDA investigational device exemption (IDE) for its enVVe system. IDE allows Irvine, California–based enVVeno (formerly Hancock Jaffe) to begin the TAVVE pivotal trial for the system. It represents a first-in-class minimally invasive, non-surgical replacement venous valve for patients suffering from severe deep chronic venous insufficiency (CVI). enVVe, […]
MMI gets FDA green light to expand study of surgical robot in Alzheimer’s
Medical Microinstruments (MMI) announced today that the FDA approved a supplement to a study of its surgical robot in Alzheimer’s. The supplement allows the company to expand patient enrollment in the REMIND investigational device exemption (IDE) study. MMI can now increase enrollment beyond the initial five-patient cohort to a full early feasibility study population of […]
