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 […]
Latest News on MassDevice
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) […]
Hyalex Orthopaedics announces first cases with synthetic knee cartilage implant
Hyalex Orthopaedics announced today that patients successfully received knee implants as part of its first-in-human clinical trials. The procedures came as part of two prospective, studies for the Hyalex Knee Cartilage System in the U.S. and Europe. Sites for both studies already enrolled and treated patients with the synthetic cartilage technology. The technology has FDA […]
Titan Medical progresses with Conavi merger
Titan Medical today provided a progress update regarding its planned merger with surgical guidance technology company Conavi Medical. The companies entered into a definitive amalgamation agreement to combine in an all-stock transaction last month. They aim to commercialize Conavi’s Novasight Hybrid system for guiding common minimally invasive coronary procedures. Conavi Medical designs, manufactures and markets imaging […]
Neuromod startup IVEAcare raises $27.5M, names CEO
Minneapolis-based neuromodulation technology developer iVEAcare announced today that it raised $27.5 million in a Series A financing round. iVEAcare spun out from NuXcel, a medical device accelerator. It seeks to develop and commercialize next-generation neuromodulation technologies to treat chronic diseases. The company also named Todd Kerkow as its new president and CEO. A medical device […]
Stryker previews next-gen monitor/defibrillator
Stryker this past week previewed a next-generation monitor/defibrillator after picking up a supplemental FDA approval. According to BTIG analyst Ryan Zimmerman, the orthopedic giant previewed the system at the Fire Department Instructors Conference (FDIC) in Indianapolis. The new LifePak 35 system received U.S.-only FDA clearance via a premarket approval (PMA) supplement on April 12. Zimmerman said […]