medical device guru

Cardiovascular / Cardiology

Cardio Diagnostics Holdings Inc to Debut PrecisionCHD™ at the American College of Cardiology’s 72nd Annual Scientific Session

Cardio Diagnostics Holdings Inc (Nasdaq: CDIO), an artificial intelligence-powered precision cardiovascular medicine company, today announced that its newest coronary heart disease test, PrecisionCHD™, will be presented at the American College of Cardiology’s 72nd Annual Scientific Session (ACC.23), taking place in...

February 22, 2023

Surgery and Surgical Robotics

Lumendi Receives 510(k) Clearance for Two New Devices

Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. The new, more cost-effective design, based...

February 21, 2023

Orthopedics and Spine

CurvaFix Launches Smaller-diameter CurvaFix® IM Implant

CurvaFix, Inc., a developer of medical devices to repair fractures in curved bones, announced the launch of its smaller-diameter, 7.5mm CurvaFix® IM Implant, designed to simplify surgery and provide strong, stable fixation in small-boned patients. The company will showcase the new...

February 16, 2023

Cardiovascular / Cardiology

TIOGA CARDIOVASCULAR, A SHIFAMED PORTFOLIO COMPANY, CLOSES $30M IN SERIES C FINANCING

Tioga Cardiovascular, a Shifamed portfolio company that aims to redefine structural heart valve replacement, announced today the first closing of its $30M Series C financing. Led by Cormorant Asset Management, with significant participation from The Capital Partnership, AMED Ventures, the...

February 14, 2023

Imaging Visualization & Navigation

Hyperfine, Inc. Announces FDA Clearance for Improved AI-Powered Software and Expanded Field of View for the Swoop® Portable MR Imaging® System

Hyperfine, Inc., the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch...

February 13, 2023

Orthopedics and Spine

Catalyst Receives FDA 510(k) Clearance for its Convertible Stemmed Total Shoulder Arthroplasty System

Catalyst OrthoScience Inc. (Catalyst), a medical device company focused on the upper extremity orthopedics market, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its fully convertible stemmed total shoulder arthroplasty system with an ellipsoid...

February 10, 2023

Orthopedics and Spine

Globus Medical and NuVasive to Combine in All-Stock Transaction to Create Innovative Global Musculoskeletal Company Focused on Patient Care

Globus Medical (NYSE: GMED), a leading musculoskeletal solutions company, and NUVASIVE (NASDAQ: NUVA), the leader in spine technology innovation, today announced they have entered into a definitive agreement to combine in an all-stock transaction. The transaction brings together two well-regarded...

February 9, 2023

Biologics, Wound Care, Infection Prevention

CoolHealth Enters U.S. Market With TargetCool™, A Breakthrough FDA-Class II Medical Device Offering Unprecedented Precise, Rapid Cooling For Pain Management And Bruise Minimization

Recens, Inc. dba CoolHealth (“CoolHealth”), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market with a breakthrough FDA-Class II medical device, TargetCool™. Leveraging groundbreaking, tuneable cooling technology, TargetCool rapidly cools the skin allowing providers to specifically set...

February 8, 2023

Diagnostics & Healthcare News

Candela Introduces the New FDA-Cleared Profound Matrix™ System

Candela, the leading provider of energy-based solutions worldwide, and the pioneer of the first and only long-pulse radiofrequency (RF) microneedling device, announces the launch of the all-new Profound Matrix™ system. Designed to correct, maintain, and restore skin at various stages...

February 6, 2023