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The FDA is rolling out AI tools agency-wide by June 30, 2025, to streamline scientific reviews and reduce task time from days to minutes.

The FDA is modernizing the 510(k) Premarket Notification Program with new submission pathways, digital tools, and updated guidances to enhance medical device safety and effectiveness.

Medtronic has announced FDA approval of its Omniasecure defibrillation lead, a device that connects to implantable cardioverter...

Senseonics is partnering with Sequel Med Tech to integrate its year-long Eversense 365 continuous glucose monitor with Sequel’s automated insulin delivery system, Twiist.

Abbott has integrated its Libreview software with Epic’s electronic health record (EHR) system, allowing clinicians across the U.S. to...

Intuitive Surgical has received FDA clearance for its da Vinci Single Port system to perform transanal rectal procedures, allowing access...

The FDA has approved nearly 1,000 AI-enabled medical devices in the past decade, marking a significant shift toward smarter, more efficient, and personalized healthcare technologies.

Researchers used surgical videos and AI similar to ChatGPT to train a robot to perform basic surgical tasks with precision and adaptability, potentially transforming robotic surgery.

Medtronic’s Simplera Sync glucose sensor has been FDA-approved for use with its 780G insulin pumps, marking a key step in the company’s push to grow its diabetes business through smarter, more integrated insulin delivery.

The FDA issued an early alert for BD’s PowerPICC catheters due to cracking and leakage risks, prompting a recall after reports of 10 serious injuries linked to material fatigue.

Field Medical raised $40 million to advance its pulsed field ablation technology for ventricular tachycardia, aiming to address a major unmet need in cardiac arrhythmia treatment.

Medtronic has filed for FDA clearance to make its MiniMed 780G insulin pump interoperable with glucose sensors developed by Abbott, a...

Properly classifying your medical device is a crucial first step in the FDA approval process, as it determines regulatory requirements, timelines, and the appropriate pathway for market entry.

The FDA 510(k) review process follows four main stages—Acknowledgment, Acceptance, Substantive Review, and Decision Letter—each with specific timelines and expectations that determine whether a device is cleared for market.

Precision Neuroscience has received FDA clearance for its Layer 7 Cortical Interface, a brain implant that can be used for up to 30 days to map brain activity, marking a key step toward developing its wireless brain-computer interface system.

A robust Quality Management System (QMS) is essential for medical device manufacturers to ensure compliance with regulatory standards, improve product quality, and manage risk throughout the product lifecycle.

Edwards Lifesciences has received CE mark approval in Europe for its Sapien M3 transcatheter mitral valve replacement system, expanding its mitral and tricuspid therapy portfolio as it targets $2 billion in global sales by 2030.

Illumina and Tempus AI have partnered to expand the use of genomic testing and precision medicine beyond oncology into broader disease areas like cardiology, neurology, and rare disorders.

Understanding whether your medical device qualifies for the 510(k), PMA, or De Novo FDA pathway is crucial for ensuring a smooth, compliant market entry based on its risk level, novelty, and intended use.

Ceribell has gained FDA 510(k) clearance to use its Clarity seizure detection algorithm on pediatric patients aged one year and older....