NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first implant of its OneRF Ablation electrode. The OneRF Ablation system is FDA 510(k) cleared to create radiofrequency nervous tissue lesions for functional neurosurgical procedures. The electrodes are a thin-film, sEEG-guided RF system that records the electrical activity and ablates nervous tissue with the added benefit of temperature control. […]
FDA clears Spirair’s SeptAlign system to treat nasal septal deviation
Spirair today announced it received FDA 510(k) clearance for its SeptAlign system to treat nasal septal deviation. The SeptAlign system uses the company’s bioabsorbable implant to straighten minor cartilaginous septal deviation. The implant won FDA clearance in August 2023. Nasal septal devition is one of the most common causes of nasal airway obstruction, making breathing […]
Abbott warns on electromagnetic interference in some Aveir leadless pacemakers
Abbott recently issued an urgent field safety notice warning physicians that some Aveir leadless pacemakers may have electromagnetic interference. The Abbott Park, Illinois-based company warned that a subset of Aveir VR LSP112V devices manufactured with firmware version 19.05.00 have the potential for electromagnetic interference that could cause an inadvertent mode change. So far, the company […]
FDA clears AngioDynamics’ AlphaVac F18 to treat pulmonary embolism
AngioDynamics this week announced it received FDA 510(k) clearance for its AlphaVac F18 system to treat pulmonary embolism (PE). The expanded FDA indication allows for the use of AlphaVac F18 system for the treatment of PE. The new indication expands the device’s use in the non-surgical removal of thrombi or emboli from the venous vasculature. […]
Henry Schein completes TriMed majority interest acquisition, adds orthopedic extremities to portfolio
Henry Schein today announced it completed the acquisition of majority interest in TriMed. Melville, N.Y.-based Henry Schein announced the acquisition in December last year. The addition of TriMed strengthens Henry Schein’s extremities portfolio. Santa Clarita, California-based TriMed makes orthopedic devices for the lower extremities (foot and ankle) and upper extremities (hand and wrist). “With this […]
WAT Medical wins FDA nod for OTC migraine preventative device
WAT Medical this week won FDA clearance for over-the-counter use of its HeadaTerm 2 wearable anti-migraine device. HeadaTerm 2 uses neuromodulation technology. It releases targeted electrical impulses that increase the pain tolerance of the wearer. It is FDA-cleared for the preventative treatment of migraine headaches and is available without a prescription in the U.S. HeadaTerm2 […]
Moon Surgical expands surgical robot indications to gynecological laparoscopy
Moon Surgical today announced its Maestro surgical robot is being used clinically in gynecological laparoscopic procedures. The Paris-based company’s surgical robot has routinely been used by eight surgeons in two facilities in France across 20 different clinical indications, including abdominal and bariatric. The recent gynecological use was for hysterectomy, cystectomy, adnexectomy and ovariectomy procedures. Surgeons […]
AngioDynamics settles patent litigations with BD’s Bard
AngioDynamics entered into a settlement agreement with BD to resolve all patent litigations with Bard. Under terms of the agreement, BD will grant a license to AngioDynamics under certain of BD’s port patents. AngioDynamics will grant BD a license under certain of AngioDynamics’ catheter payments. AngioDynamics will also make a one-time payment of $7 million, […]
GE HealthCare closes MIM Software acquisition
GE HealthCare this week announced it closed its acquisition of MIM Software. The Chicago-based imaging company previously announced the buy in January. GE HealthCare funded the acquisition — for which financial terms were not disclosed — with cash on hand. MIM Software provides AI-based software for radiation oncology, molecular radiotherapy, diagnostic imaging and urology. The […]
GE HealthCare names new chief communications officer
GE HealthCare today announced it appointed Rana Strellis as chief corporate marketing and communications officer. Strellis replaces Danielle Halstrom who transitioned to the same role at the GE HealthCare Foundation two weeks ago. She will drive the company’s corporate brand, reputation and narrative forward internally and externally. “Rana brings a wealth of functional expertise in […]
FDA wants to ban electrical stimulation devices for self-injurious, aggressive behavior
In a rare move, the FDA is taking steps to ban electrical stimulation devices (ESDs) for self-injurious or aggressive behaviors. Owen Faris, acting director of the Office of Product Evaluation and Quality (OPEQ) in the FDA’s Center for Devices and Radiological Health, announced the proposal this week, marking the second attempt by the agency to […]