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Diagnostics & Healthcare News

Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Owlet (NYSE: OWLT, “the Company”), the pioneer of smart baby monitoring, announces clearance from the U.S. Food and Drug Administration (“FDA”) of BabySat™, the first medical pulse-oximetry device featuring its advanced, wire-free sock design. Owlet is a leader in infant...

June 20, 2023

Diagnostics & Healthcare News

Cala® Launches The Cala kIQ™ System, Offering Meaningful Tremor Relief for Patients With Essential Tremor and Now Parkinson’s Disease

Cala, the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ™ System, the first and only FDA-cleared wearable device that delivers effective therapy for...

June 15, 2023

Diagnostics & Healthcare News

FDA Clears CorNeat EverPatch, World’s First Non-degradable, Synthetic Tissue Substitute for Ophthalmic Surgery

CorNeat Vision’s EverPatch, a synthetic tissue substitute, has been granted 510(k) clearance by the US Food & Drug Administration (FDA). The CorNeat EverPatch is the first synthetic, non-degradable tissue-integrating matrix for use in ophthalmic surgeries. It is composed of a non-woven,...

June 13, 2023

Diagnostics & Healthcare News

Avails Medical’s eQUANT™ System Submitted to FDA for 510(k) Clearance

Avails Medical, a pioneer in rapid, automated and fully electrical antibiotic susceptibility testing (AST) solutions announced today the submission of its eQUANTTM system for FDA 510(k) clearance. The eQUANT system provides a standardized inoculum (0.5 McFarland equivalent) directly from a positive...

June 12, 2023

Diagnostics & Healthcare News

Biosency detects early COPD exacerbations thanks to Bora care®, a predictive digital medical device

The American Thoracic Society International Conference (ATS 2023) took place in Washington, D.C. from 19 to 24 May 2023. During the conference on 23 May, French MedTech Biosency unveiled its latest clinical results demonstrating the ability of its BVS3 technology to predict acute COPD (chronic obstructive...

May 26, 2023

Diagnostics & Healthcare News

iHealthScreen Inc. Announces FDA 510K Submission for iPredict™ AMD tool

iPredictTM AI Eye Screening System provides fully automated age-related macular degeneration (AMD) screening, including retinal imaging and immediate reporting of actionable results. Using the iPredictTM System, primary care and various specialty practices can accurately and efficiently screen people over 50 for AMD and...

May 24, 2023

Diagnostics & Healthcare News

Bionix® Introduces IsoMark™ A Revolutionary Patient Marking Device for Radiation Oncology Treatment

For more than a decade, Bionix has supplied the radiation oncology sector of the healthcare industry with Accu-Tatt®, an all-inclusive, sterile, single-use tattooing device that marks targeted areas on a patient’s body for proper alignment during radiation therapy procedures. Working...

May 15, 2023

Diagnostics & Healthcare News

Sibel Health Announces a New FDA-Clearance for Advanced Wireless Monitoring in Neonates and Infants

Sibel Health, an award-winning digital health company spun out of the Querrey Simpson Institute for Bioelectronics at Northwestern University, announces a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any...

May 10, 2023

Diagnostics & Healthcare News

Clinical Study Results of the BlueWind System for Patients with Overactive Bladder Featured at the 2023 AUA Annual Meeting

BlueWind Medical, Ltd., the developer of a transformative implantable tibial neuromodulation therapy for Overactive Bladder (OAB), today announced results from the OASIS pivotal trial evaluating the safety and efficacy of the BlueWind System in the treatment of OAB. The results...

May 1, 2023