Sail Fusion today announced it received FDA 510(k) clearance for its BowTie Sacroiliac Fusion System. The Del Mar, California-based sacroiliac device company designed the device to incorporate intra-articular and transfixing components. BowTie minimizes tissue disruption, thoroughly prepares the joint, and provides rigid fixation to enable robust arthrodesis. “There hasn’t been meaningful differentiation in the SI […]
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Medtronic names new chief regulatory officer
Medtronic officials today shared that the medtech giant named Yarmela Pavlovic as its new chief regulatory officer. Pavlovic posted the news on LinkedIn: “I’m excited to share that I’ve recently been named chief regulatory officer for Medtronic. Medtronic products touch the lives of 74 million patients per year, and I’m honored to continue to support […]
Front Line Medical wins CE mark for COBRA-OS device
Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device. The CE mark gives EU medical providers access to the Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS). The device already has FDA clearance and Health Canada approval. “The CE marking of the COBRA-OS is momentous for our company, as […]
Non-insulin, basal CGM use exceeds analysts’ expectations, Dexcom and Abbott to benefit
William Blair analyst Margaret Kaczor reported surprise at the increase in users of CGM within the non-insulin and basal insulin populations. Kaczor expects Dexcom and Abbott to benefit from the trend with their next-generation CGM offerings after meetings with both companies’ management. Both companies launched next-gen CGMs in recent years (Dexcom G7 and Abbott FreeStyle […]
FDA clears Epitel remote monitoring tech, AI detection platform
Epitel announced today that it received FDA 510(k) clearance for two new patient-focused brain health offerings. The FDA cleared the Remi remote EEG monitoring system for ambulatory use and the Remi Vigilenz AI for event detection. Remi for ambulatory use allows for EEG recording in outpatient and home environments for an extended duration. Vigilenz AI […]
Vantage MedTech names Jim Bartel as CEO
Vantage MedTech today announced it appointed Jim Bartel as CEO. Bartel has more than 25 years of leadership experience within the medical device and contract manufacturing industries. He has held various roles in leading marketing, business development and sales teams. Most recently, Bartel was CEO and board member of Waltek, a private equity-owned casting and […]
Neuronoff hits first-in-human milestone for Injectrode neuromod
Neuronoff announced today that it completed the first-in-human clinical trial evaluating its flagship Injectrode neuromodulation product. The Cleveland-based company designed Injectrode to treat chronic pain. The LIFE (lumbar Injectrode feasibility evaluation) trial evaluated Injectrode’s safety and effectiveness, meeting all goals, the company said. Injectrode placement comes through an 18-gauge needle (no incisions) under local analgesia […]
Thermedical completes feasibility study to use SERF with PFA
Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system. Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT). According to Thermedical, SERF (saline-enhanced radio frequency) ablation provides a new, more efficient form of biological […]
FDA clears computer-assisted thrombectomy system from Penumbra
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 […]
Exo adds AI-powered cardiac, lung apps to handheld ultrasound
Exo announced today that it launched its FDA-cleared cardiac and lung AI applications for the Iris handheld ultrasound device. The company now has FDA clearance for five different applications on Iris — cardiac, lung, bladder, hip and thyroid. It expects to double that number by 2025. Iris delivers high-performance medical imaging at a fraction of […]
Medtronic launches next-gen surgical aortic tissue valve
Medtronic today announced the launch of its next-generation Avalus Ultra surgical aortic tissue valve. The medtech giant designed the valve to facilitate ease of use at implant and lifetime patient management. It offers clear visibility for future valve-in-valve procedures and straightforward sizing. Other features of Avalus Ultra include a low profile and a polyetheretherketone (PEEK) […]