Medtronic (NYSE:MDT) today announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology. The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization. Medtronic said in a news release that 87% […]
FDA clears automated insulin pump from Beta Bionics for type 1 diabetes
The FDA announced today that it cleared the Beta Bionics iLet ACE automated insulin pump and iLet dosing decision software. FDA clearance covers the devices for people 6 years of age and older with type 1 diabetes. Combined with a compatible, FDA-cleared integrated continuous glucose monitor (iCGM), they form the iLet Bionic Pancreas. Using an […]
Vicarious Surgical promotes John Mazzola to COO
Vicarious Surgical (NYSE:RBOT) announced that it promoted John Mazzola to the role of chief operating officer (COO). Mazzola joined the Waltham, Massachusetts-based surgical robotics company in March 2022 as SVP of operations. He brings with him more than 35 years of experience in the medical device industry. That includes involvement in more than 25 medical […]
Virtual Incision submits surgical robot for FDA de novo review
Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo review. Lincoln, Nebraska-based Virtual Incision seeks authorization to market MIRA for use in bowel resection procedures. The submission follows a completed FDA investigational device exemption (IDE) study. FDA approved the IDE supplement for MIRA in April 2022. MIRA could […]
Abbott, Stereotaxis ink robotic surgery partnership
Stereotaxis (NYSE:STXS) announced today that it has entered into a collaboration with Abbott (NYSE:ABT) to take robotic electrophysiology to the next level. The collaboration aims to integrate the Abbott EnSite X EP system — a 3D heart mapping system — with Stereotaxis’ robotic magnetic navigation systems. Bringing the Abbott cardiac mapping system together with Stereotaxis’ […]
Cadence Neuroscience raises $26M to support epilepsy neuromod therapy
Neurmodulation technology developer Cadence Neuroscience announced that it secured $26 million in a Series B financing round. The Angelini Lumira Biosciences Fund led the round. It also included new investors F-Prime Capital, LivaNova USA, Angelini Ventures, Spectrum Financial Services and Mayo Clinic. Series A lead investor, Jazz Venture Partners, also contributed. In connection with the […]
Study supports smart blood glucose meter from LifeScan
LifeScan today announced positive data from a study of real-world evidence supporting its Bluetooth-connected blood glucose meter. Evidence from more than 55,000 people with diabetes demonstrated sustained improvements in readings in range. The analysis focuses on changes over 180 days. LifeScan published results in the peer-reviewed journal Diabetes Therapy. The company’s OneTouch Bluetooth-connected blood glucose […]
FDA approves next-gen MicroPort CRM pacemakers
MicroPort CRM announced today that it received FDA approval for its Alizea and Celea implantable pacemakers. The cardiac rhythm management subsidiary of MicroPort Scientific said its newly approved devices are the longest-lasting pacemakers for their size on the market today. They offer a volume of just 11cc and a projected longevity of 13 years. Additionally, […]
Paradromics raises $33M, wins FDA breakthrough nod for brain-computer interface tech
Paradromics announced today that it raised $33 million in a Series A funding round and garnered an FDA breakthrough device designation. Austin, Texas-based Paradromics develops a high data-rate brain-computer interface (BCI). The company sees its latest financial and regulatory progress as a positive step into the competitive BCI market. Paradromics plans to use the funding […]
FDA clears insertable cardiac monitor from Abbott
Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. […]
HeartBeam submits AIMIGo vector ECG for FDA 510(k) clearance
HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) application to the FDA for its AIMIGo system. AIMIGo, a personal, portable vector electrocardiogram (VECG) system assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-sized VECG recording device and cloud-based software. The system can deliver critical data to clinicians in real-time outside […]
