Latest Headlines

  1. FDA Clears Mariner Endosurgery’s Augmented Surgical System

    Following months of review, the US Food and Drug Administration cleared Mariner Endosurgery’s LaparoGuard Augmented Surgical Navigation system for use in US operating rooms.

  2. Excelitas Technologies To Acquire Axsun Technologies

    Excelitas Technologies® Corp., a global technology leader focused on delivering innovative, customized photonic solutions, today announced that it has signed a definitive agreement to acquire Axsun Technologies (Billerica, MA USA).

  3. Garmin Health, ActiGraph Partner On Wearable Solutions For Clinical Trials

    Garmin International, Inc., a unit of Garmin Ltd., today announced a collaboration with ActiGraph to explore creation of innovative health and activity monitoring solutions that would utilize Garmin wearables and ActiGraph‘s CentrePoint data analytics platform for academic research, clinical trials, and remote patient monitoring.

  4. FDA Clears Mobile Medical App That Helps Patients With Opioid Use Disorder Stay In Recovery

    Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates) in an outpatient treatment program for individuals with opioid use disorder (OUD).

  5. FDA Clears Bittium’s ECG Device For Detection Of Arrhythmias

    The new waterproof Bittium Faros ECG devices, Bittium Cardiac Navigator and Bittium Cardiac Explorer analysis software received FDA 510(k) medical device clearances in United States. The FDA 510(k) clearance received by the Bittium Faros ECG device includes the built-in algorithms for detection of arrhythmias.

  6. Bay Labs, Edwards Lifesciences Collaborate On AI Software To Improve Heart Disease Detection

    Bay Labs, a medical technology company at the forefront of applying artificial intelligence (AI) to cardiovascular imaging, announced recently a collaboration with Edwards Lifesciences focused on improving the detection of heart disease.

  7. Hologic Launches Three-In-One Omni Hysteroscope

    Hologic, Inc. announced recently the U.S. launch of its Omni hysteroscope, an innovative three-in-one modular scope with advanced visualization capabilities designed for both diagnostic and therapeutic hysteroscopic procedures.

  8. FDA Clears iCAD’s AI For Digital Breast Tomosynthesis

    iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today announced clearance by the United States Food and Drug Administration (FDA) for their latest, deep-learning, cancer detection software solution for digital breast tomosynthesis (DBT), ProFound AI™, clearing the technology for commercial sales and clinical use in the United States.

  9. Luma Therapeutics Launches In-Home Treatment For Plaque Psoriasis

    Luma Therapeutics, a company dedicated to eradicating suffering from inflammatory skin disease, recently announced the launch of an innovative light-based therapy for the treatment of plaque psoriasis.

  10. Subtle Medical’s AI Imaging Solution Gains FDA 510(k), CE Mark Approval

    Subtle Medical, a privately-held medical device company focused on improving medical imaging efficiency and patient experience with innovative deep learning imaging technologies, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtlePETTM.