| |

U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD

Non-Invasive, Self-Neuromodulation, Adjunct to Standard of Care Therapy Using Amygdala Derived EEG-fMRI Pattern Biomarkers to Help Patients with PTSD GrayMatters Health (GMH), developer of digital self-neuromodulation therapies for mental disorders, has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its flagship product, Prism for PTSD, the first non-invasive, self-neuromodulation adjunct digital…
| |

Understand your body better with the new ECG App from Garmin

FDA-cleared and clinically-validated app lets Venu 2 Plus customers record an ECG and check for signs of atrial fibrillation right from their smartwatch Garmin announced the ECG App, an FDA-cleared app for the Venu 2 Plus smartwatch that allows users to record their heart rhythm and check for signs of atrial fibrillation (AFib) anytime, anywhere….
|

AliveCor Lists its Industry-leading KardiaMobile 6L in Epic’s App Orchard Marketplace

KardiaMobile 6L personal ECG now integrated into Epic EHR AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, announced that KardiaMobile 6L, the most clinically-validated six-lead personal ECG device, is now available via KardiaPro on Epic’s App Orchard Marketplace for hospitals, health systems and providers. The integration will enable even more healthcare providers around…
|

Aidoc Releases the First ‘OS’ Unifying AI Across Enterprise Imaging to Address Technical Barriers of Using AI

Health networks can now continuously expand their AI stack without overhauling their IT infrastructure with each new tool Aidoc, a provider of artificial intelligence (AI) solutions for medical imaging, announced the release of the first AI Operating System (OS) allowing for the clinical use of numerous AI applications over one unified system. To complement its…

Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESA (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine

TRUDHESA Is the First and Only Therapeutic to Use POD technology to Deliver Dihydroergotamine Mesylate (DHE) to the Vascular-Rich Upper Nasal Space Impel NeuroPharma, Inc., a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, announced that the U.S….
| |

Q&A: FDA Panel Member Tells Healthline Why He Resigned Over Alzheimer’s Drug Approval

An interview between Healthline and former FDA panel member. Dr. Aaron S. Kesselheim, MPH, began advising the Food and Drug Administration (FDA) in 2015, and then joined one of its advisory panels as a permanent member in 2019. At that time, he was ready to use the skills he’d acquired in a successful medical career…
|

BioIntelliSense Announces FDA Clearance of the BioSticker™, the First Single-Use Medical Device Enabling 30 Days of Continuous Vital Signs Monitoring

An effortless patient experience combined with actionable clinical intelligence to bring medical-grade care to the home BioIntelliSense, Inc., a continuous health monitoring and clinical intelligence company, today announces the U.S. commercial launch of its medical grade Data-as-a-Service (DaaS) platform and FDA 510(k) clearance of the BioSticker™ on-body sensor for scalable remote care. BioIntelliSense offers a…