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Device Pipeline and Approvals

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Symphony Thrombectomy system: ©Imperative Care
Imperative Care wins FDA Clearance for device to treat pulmonary embolism

September 2nd 2025

Imperative Care's Symphony Thrombectomy System gains FDA clearance, advancing pulmonary embolism treatment with enhanced control and faster recovery options.

OTC glucose monitor launches: ©Andrey Popov - stock.adobe.com
Signos launches first FDA-cleared over-the-counter glucose monitoring system for weight management

August 25th 2025

O3 Regional Oximetry receives FDA Clearance for expanded parameters: ©Masimo
Masimo wins FDA Clearance for expanded parameters for its O3 Regional Oximetry device

August 19th 2025

AI-powered prostate cancer tool authorized: ©Drmicrobe - stock.adobe.com
FDA grants De Novo authorization for first AI-powered prostate cancer prognostic tool

August 13th 2025

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August 13th 2025

More News

FDA approves marketing of at-home STI test: ©Pawel - stock.adobe.com

FDA approves marketing of first at-home test for chlamydia, gonorrhea, and trichomoniasis

Todd Shryock
March 28th 2025

Test is designed for females regardless of symptoms and gives results in about 30 minutes

FDA layoffs delaying medical device reviews: ©Arakillustrations - stock.adobe.com

FDA layoffs delaying medical device reviews

Todd Shryock
March 27th 2025

Media report highlights how FDA workloads have increased, and delays for new technology approvals will likely suffer

FDA approves new fetal monitor: ©Faustasyan - stock.adobe.com

New technology aims to standardize and modernize maternity care

Todd Shryock
March 25th 2025

FDA approves Dawes-Redman CTG analysis for U.S. use, enhancing fetal monitoring

U.S. Food and Drug Administration controversial layoffs (FDA) © Tada Images - stock.adobe.com

FDA layoffs spark industry, lawmaker backlash over risks to patient safety

Austin Littrell
February 21st 2025

AdvaMed, Senate Democrats warn of regulatory slowdowns and public health threats following mass layoffs at the FDA.

AI-powered rib fracture detection technology receives FDA clearance: ©Crystal Light - stock.adobe.com

Aidoc secures FDA clearance for AI-powered rib fracture detection

Todd Shryock
February 19th 2025

Triage solution is built on existing AI engine

AI-powered screening shows promising results: ©Анна Ковальчу - stock.adobe.com

AI-powered diabetic retinopathy screening shows promising results

Todd Shryock
February 13th 2025

Autonomous solution doesn’t require dilation in vast majority of cases

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