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Theradaptive Receives FDA Approval for Pivotal OsteoAdapt SP Trial in Spinal Fusion

Theradaptive Receives FDA Approval for Pivotal OsteoAdapt SP Trial in Spinal Fusion

Theradaptive Receives FDA Approval for Pivotal OsteoAdapt SP Trial in Spinal Fusion
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enVVeno Medical Secures FDA IDE Approval for Pivotal Study on Non-Surgical Venous Valve

enVVeno Medical Secures FDA IDE Approval for Pivotal Study on Non-Surgical Venous Valve

enVVeno Medical Secures FDA IDE Approval for Pivotal Study on Non-Surgical Venous Valve
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Adagio Medical to Present at BofA Securities 2026 Healthcare Conference Highlighting Cardiac Arrhythmia Innovations

Adagio Medical to Present at BofA Securities 2026 Healthcare Conference Highlighting Cardiac Arrhythmia Innovations

Adagio Medical to Present at BofA Securities 2026 Healthcare Conference Highlighting Cardiac Arrhythmia Innovations
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FDA and Paradigm Health Collaborate to Modernize Clinical Trial Data Review

FDA and Paradigm Health Collaborate to Modernize Clinical Trial Data Review

FDA and Paradigm Health Collaborate to Modernize Clinical Trial Data Review
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enVVeno Medical Secures FDA IDE Approval for Non-Surgical Venous Valve Study

enVVeno Medical Secures FDA IDE Approval for Non-Surgical Venous Valve Study

enVVeno Medical Secures FDA IDE Approval for Non-Surgical Venous Valve Study
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Adagio Medical to Present at BofA Securities 2026 Health Care Conference

Adagio Medical to Present at BofA Securities 2026 Health Care Conference

Adagio Medical to Present at BofA Securities 2026 Health Care Conference
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Adagio Medical to Present at BofA Securities 2026 Healthcare Conference

Adagio Medical to Present at BofA Securities 2026 Healthcare Conference

Adagio Medical to Present at BofA Securities 2026 Healthcare Conference
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NeuroPace's RNS System Shows Significant Seizure Reduction in Epilepsy Patients

NeuroPace's RNS System Shows Significant Seizure Reduction in Epilepsy Patients

NeuroPace's RNS System Shows Significant Seizure Reduction in Epilepsy Patients
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FDA Approves Brain-Zapping Device as Alternative to SSRIs for Depression

FDA Approves Brain-Zapping Device as Alternative to SSRIs for Depression

The FDA has approved a new device, the Flow FL-100, which offers a novel approach to treating depression. Developed by Swedish company Flow Neuroscience, this device uses transcranial direct-current stimulation (tDCS) to deliver weak electrical currents to the brain. It is designed to be used at home under remote supervision and is seen as a potential alternative to traditional antidepressants like Prozac. The device has been available in Europe for some time and is now cleared for use in the U.S. as a first-line treatment option. While the device showed modest improvements in a U.S. trial, with 58% of users experiencing some response, experts caution that it is still in the early stages of development and should not be seen as a replacement for antidepressants.
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Berlin Heals Reports Positive Results from CMIC-III Heart Failure Study

Berlin Heals Reports Positive Results from CMIC-III Heart Failure Study

Berlin Heals Holding AG has presented positive results from its CMIC-III First-In-Human study at the Heart Rhythm Society's Congress in Chicago. The study evaluated a less invasive approach to implanting the cardiac microcurrent (CMIC) device, showing significant improvements in left ventricular ejection fraction, 6-minute walk test, quality of life, and New York Heart Association class. The CMIC system was implanted via an outpatient procedure, enhancing safety and accessibility for heart failure patients. Berlin Heals plans to expand the study to include patients with mildly reduced ejection fraction and launch a double-blind sham-controlled trial across Western Europe.
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Shoulder Innovations Launches InSet I-135RFX Humeral Stem, Expanding Surgical Options

Shoulder Innovations Launches InSet I-135RFX Humeral Stem, Expanding Surgical Options

Shoulder Innovations Launches InSet I-135RFX Humeral Stem, Expanding Surgical Options
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Motif Neurotech Receives FDA Approval for Clinical Trial on Depression Treatment

Motif Neurotech Receives FDA Approval for Clinical Trial on Depression Treatment

Motif Neurotech, a company specializing in brain-computer interface (BCI) technology for mental health, has received approval from the U.S. Food and Drug Administration (FDA) to begin its first clinical trial. The trial, known as the RESONATE Early Feasibility Study, will evaluate the Motif XCS System, a wirelessly powered implant designed to deliver electrical stimulation to a specific brain region. This stimulation aims to reduce symptoms of depression in adults who have not found relief from two or more medications. The study will be conducted at eight leading medical institutions, including Baylor College of Medicine and Massachusetts General Brigham. The primary goal is to assess the safety and effectiveness of the device over a 12-month period.