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 […]
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 […]
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 […]
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 […]
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 […]
GE HealthCare adds MIM Software to Elekta collaboration
GE HealthCare announced today that it expanded its relationship with Elekta with more collaboration on software for radiation oncology. Together, the companies aim to accelerate innovation in software to improve workflows, increase throughput and enhance user experience. They expect to enable greater precision in radiation therapy treatment with less time at the hospital for patients. […]
CroíValve is set to challenge as tricuspid regurgitation treatment space heats up
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]