EndoQuest Robotics announced today that it received FDA investigational device exemption (IDE) for a study of its surgical robot. The IDE allows the Houston, Texas-based company to evaluate its Endoluminal Surgical (ELS) system in colorectal surgery. Its landmark multi-center, open-label study looks at the the ELS system’s safety and performance in robotic endoscopic submucosal dissection […]
About Sean Whooley
Pentax wins FDA nod for new models of endoscopes
Pentax Medical announced today that it earned FDA 510(k) clearance for new models of its i20c video endoscope series. The new models — the Video Colonoscope EC34-i20cL, Video Upper GI Scope EG27‑i20c and Right/Left Wheel Extender OE-B17 — work in combination with the Pentax Medical Inspira Video Processor EPK-i8020c. They support healthcare professionals in detection, diagnosis […]
Siemens Healthineers acquires Novartis molecular imaging business
Siemens Healthineers announced today that it completed the acquisition of Advanced Accelerator Applications Molecular Imaging from Novartis. The newly acquired unit is a European manufacturing and distribution network of diagnostic radiopharmaceuticals for positron emission tomography (PET) scans. According to a news release, it will be known as “Advanced Accelerator Applications, a Siemens Healthineers company.” Reports first […]
Terumo, Medis announce strategic partnership to enhance cardiovascular care
Terumo Health Outcomes and Medis Medical Imaging today announced a strategic partnership to enhance cardiovascular care in the U.S. The companies plan to utilize Terumo’s ePRISM proprietary clinical decision support platform with Medis’ quantitative flow ratio (QFR) technology — a non-invasive software solution for assessing angiography-derived coronary physiology. They plan to pilot the use of […]
Second Heart Assist concludes mechanical circulatory support trial
Second Heart Assist announced today that it completed the third in a planned series of studies for its mechanical circulatory support device. Whisper, a catheter-based, minimally invasive device, utilizes a stent cage fitted with a motorized impeller. It aids in providing circulatory support throughout a patient’s body. The system is intended for use in patients […]
Microbot Medical submits Liberty surgical robot to FDA
Microbot Medical (Nasdaq:MBOT) announced today that it submitted an FDA 510(k) premarket notification for its Liberty surgical robot. Microbot designed its Liberty single-use endovascular surgical robot for potential use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure and physical strain on physicians. […]
Medtech M&A could be on the rise in 2025
Analysts from Bank of America predict a favorable environment for mergers and acquisitions in the medtech space in 2025. Travis Steed, Stephanie Piazzola, Craig Bijou and Enjia Cao say 2024 was “a typical year” in terms of M&A in medtech. They tracked 19 acquisitions of note with around $25 billion in disclosed deal price. Some […]
SetPoint Medical submits neuromod device to FDA
SetPoint Medical announced today that it filed with the FDA for premarket approval (PMA) of its neuroimmune modulation device. The Valencia, California-based company develops the system as a potential first-of-its-kind treatment for moderate-to-severe rheumatoid arthritis (RA). Its target population are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). SetPoint designed […]
Stereotaxis wins approval in China for magnetic ablation catheter
Stereotaxis (NYSE:STXS) announced today that its Magbot magnetic navigation ablation catheter received regulatory approval in China. This nod comes just weeks after the company won approval from China’s National Medical Products Administration for the Genesis robotic magnetic navigation (RNM) system. St. Louis, Missouri-based Stereotaxis aims to accelerate access to its minimally invasive technology in China. […]
Cala Health raises $50M growth round
Cala Health announced today that it raised a $50 million growth financing round to support its TAPS therapy. Vertex Growth Fund and Nexus NeuroTech Ventures co-led the financing round. All existing investors, including Action Potential, Johnson & Johnson, Lightstone, Lux, GV (Google Ventures), OSF Ventures, Ascension Ventures, TriVentures, Reimagined Ventures, Peak6 and Fiscus also participated. […]
Vicarious Surgical CFO departs, surgical robot timeline is unchanged
Vicarious Surgical (NYSE:RBOT) announced that CFO William Kelly plans to leave the company to pursue other career opportunities. Kelly joined the Waltham, Massachusetts-based company as CFO in January 2021. About four years later, Kelly expects to depart on Jan. 2, 2025. He plans to assist the company to ensure minimal disruption and a successful transition […]
