Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces. Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart. Looking at those two spaces in particular, here are five […]
Diagnostics
Samsung partners with Lunit on AI for enhanced chest screenings
Samsung announced today that it entered into a supply contract with Lunit to utilize its AI-powered solutions for chest screenings. Boston Imaging, the U.S. headquarters of Samsung’s digital radiography and ultrasound business, inked the deal. Lunit offers AI technology for cancer diagnostics and therapeutics. Together, they aim to enable faster and more accurate chest screenings […]
FDA clears Syngo Virtual Cockpit tech from Siemens Healthineers
Siemens Healthineers announced that the FDA cleared its Syngo Virtual Cockpit, a private, secure communication platform. The platform enables real-time image visualization, acquisition and collaboration between healthcare professionals across multiple sites. Siemens Healthineers designed the software so users can connect to CT, MR, PET and a number of other scanners. Scanners include those made by […]
HeartFlow earns reimbursement win for AI-based coronary solutions
HeartFlow announced today that the American Medical Association (AMA) transitioned reimbursement codes for its coronary artery disease assessment. The AMA changed the non-invasive, AI-based FFRCT treatment to a Category I Current Procedural Terminology (CPT) code. It went into effect on Jan. 1, 2024. Mountain View, California-based HeartFlow says the new code supports FFRCT as the […]
FDA clears AI-based lung analysis software from Thirona
Thirona announced today that it received FDA 510(k) clearance for the latest update of its AI-based LunQ clinical software. LungQ 3.0.0 utilizes AI to automatically segment the pulmonary segments and subsegments in the internal anatomy of the lung. The analysis includes the identification of structures like lobes, segments, subsegments, airways and fissures. It analyzes the […]
Court grants AliveCor stay in patent battle with Apple as PTAB investigation goes on
The United States District Court of the Northern District of California allowed AliveCor a stay in legal proceedings against tech giant Apple. AliveCor and Apple have a longstanding legal battle ongoing over the use of ECG technology for detecting AFib. Last week, the U.S. Patent Trial and Appeal Board’s (PTAB) agreed to institute three of […]
FDA clears DermaSensor AI-powered skin cancer detection device
DermaSensor announced today that the FDA cleared its real-time, non-invasive, AI-powered skin cancer evaluation system. Miami-based DermaSensor develops a handheld device that uses ESS, a form of optical spectroscopy. It takes noninvasive samples of tissue, capturing cellular-level information. The technology uses hundreds of wavelengths of light in a manner similar to how sonar uses sound. […]
Zoll wins regulatory nods for Thermogard temperature management system
Zoll this week announced it received FDA clearance and CE mark approval for upgrades to its Thermogard temperature management system. Upon these regulatory wins, Thermogard now offers the versatility of core and surface-based temperature management treatment options. The single, streamlined platform has solutions for personalized patient care with precise temperature control and intelligent analytics. “Thermogard […]
Endotronix submits pulmonary artery sensor for FDA premarket approval
Endotronix announced today that it submitted a premarket approval (PMA) application to the FDA for its Cordella system. Cordella, a pulmonary artery (PA) sensor system, enables proactive, data-driven heart failure (HF) management. It engages patients, reduces and prevents congestion and improves outcomes. The Cordella system delivers proactive PA pressure data and non-invasive vital health data […]
Nanowear wins FDA nod for AI-enabled wearable blood pressure monitor
Nanowear announced today that its SimpleSense nanotechnology-enabled wearable and software platform received FDA 510(k) clearance. The AI-enabled noninvasive, cuffless, continuous blood pressure monitor and diagnostic offers a tool in the diagnostic management of hypertension. It adds to the wearable platform’s previously cleared cardiopulmonary diagnostics. The FDA cleared it as software as a medical device (SaMD). […]
HeartFlow hits 250,000-patient mark
HeartFlow announced today that it surpassed 250,000 patients receiving its FFRCT Analysis for non-invasively diagnosing coronary artery disease. FFRCT Analysis and coronary computed tomography angiography (CCTA), provide an alternative to traditional ischemia testing methods. These methods include stress EKG, stress ECG, SPECT, PET and more. According to HeartFlow, these methods can result in false negatives […]