AtaCor Medical announced today that it completed a $28 million Series C financing round to support its cardiac pacing and defibrillator technology. Arboretum Ventures led the financing round. Existing investors Longview Ventures, Hatteras Venture Partners, Catalyst Health Ventures and BayMed Venture Partners participated, too. San Clemente, California-based AtaCor plans to use the funds to support […]
Latest News on MassDevice
FDA wants to advance health equity through home-based care
The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans. The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and […]
Blue Arbor wins FDA breakthrough nod for neuromuscular interface
Blue Arbor Technologies announced today that it received FDA breakthrough device designation for its Restore neuromuscular interface system. The FDA also accepted the system into its Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. TAP provides early and frequent strategic engagement from the FDA, patients, providers and payers. It facilitates rapid development and widespread […]
Boston Scientific stock is up as Farapulse drives Q1 beat, raised guidance
Boston Scientific shares got a boost this morning on first-quarter results that came in ahead of the consensus forecast. Shares of Boston Scientific ticked up nearly 7% to $73.66 apiece in early-morning trading today. They got as high as $74.39 during the day, marking a 52-week best for the company. MassDevice’s MedTech 100 Index — […]
FDA clears Sail Fusion’s BowTie Sacroiliac Fusion System
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 […]
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 […]