medical device guru

Diagnostics & Healthcare News

New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy

Eyenuk, a global artificial intelligence (AI) digital health company, and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, has received U.S. Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with...

June 22, 2023

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

Resource Library

A Candid Conversation with Our CEO and Founder on Conquering Remote Work Challenges | Legacy MEDSearch

Written by: Melissa King and Paula Rutledge Legacy MedSearch has more than 35 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the...

June 20, 2023

Cardiovascular / Cardiology

FDA Approves Innovative 4D Flow MRI Blood Flow Analysis Software from Cardio Flow Design Inc.

The US Food and Drug Administration has approved the use of iTFlow® in blood flow analysis. The FDA approval is significant as it recognizes the safety and effectiveness of iTFlow® in analyzing blood flow through 4D Flow MRI data, with...

June 19, 2023

Orthopedics and Spine

Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System

Centinel Spine®, LLC, (“the Company”) a leading global medical device company addressing cervical and lumbar spinal disease by providing the most robust and clinically-proven total disc replacement technology platform in the world (prodisc®), today announced the completion of enrollment in...

June 16, 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

Surgery and Surgical Robotics

Surmodics Receives FDA 510(k) Clearance for Pounce™ LP Thrombectomy System

Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ LP (Low Profile) Thrombectomy System. Introduced in 2021, the Pounce...

June 14, 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