Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system. Lightning Flash 2.0 represents the next generation of the company’s computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE). The system features Lightning Flash algorithms designed for increased […]
Vascular
Concept Medical enrolls first patient in drug-coated balloon study
Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system. MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey. The balloon […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
Nectero Medical closes $96M Series D
Nectero Medical announced today that it closed a Series D financing round to support its abdominal aortic aneurysm treatment. Norwest Venture Partners led the round. Boston Scientific, BioStar Capital, Cadence Healthcare Ventures, Aphelion Capital and other firms contributed large investments to the $96 million money raise. The funds add to a $19.5 million Series C […]
Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope
Synaptive Medical announced today that it received FDA 510(k) clearance for its near-infrared fluoresence visualization module on its robotic exoscope. The Toronto-based company can now add its Modus IR module to the existing fluorescence offering on the 4K, 3D Modus X system. Modus IR bolsters the capabilities of the exoscope across all neurosurgical procedures, as […]
Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold
Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Inari Medical has positive ClotTriever data
Inari Medical announced positive two-year interim results from the CLOUT registry evaluating its ClotTriever system. Principal investigator Dr. David Dexter of Sentara Vascular Specialists in Norfolk, Virginia, presented the data at the American Venous Forum. Results represent the largest prospective, multi-center, two-year dataset in deep-vein thrombosis (DVT) since the ATTRACT trial, Inari said in a […]
Boston Scientific has positive Agent DCB study results
Boston Scientific reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB). The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to […]
Nanoflex Robotics announces first U.S. surgical robot installation
Nanoflex Robotics announced today that it installed its first remote-ready robotics system for neurovascular procedures in the U.S. The installation took place at The Jacobs Institute, a nonprofit medical device innovation center in Buffalo, New York. Zurich, Switzerland-based Nanoflex designed its robotic system with a compact magnetic field generator and a navigation control unit. These […]
Gradient begins pulmonary artery denervation trial in the U.S.
Gradient Denervation Technologies announced today that it won FDA approval to begin an early feasibility study in the U.S. The PreVail-PH2 study evaluates its minimally invasive, ultrasound-based device for treating pulmonary hypertension with associated heart failure. Paris-based Gradient already enrolled the first patient at Duke University Hospital in Durham, North Carolina. Dr. Marat Fudim and […]
Endologix picks former Medtronic leader as new chief commercial officer
Endologix announced today that it appointed Mike Mathias as its new chief commercial officer (CCO), effective immediately. Mathias brings 30 years of experience leading commercial organizations within the cardiovascular area. He most recently served as VP of commercial operations at Limflow. He held that role from 2022 until Inari Medical acquired the chronic limb-threatening ischemia […]