medical device guru

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

Surgery and Surgical Robotics

VERO Biotech’s Second Generation GENOSYL® Delivery System (DS) Receives FDA Approval in Anesthesia in the Surgical Suite

VERO Biotech Inc., a commercial-stage healthcare business dedicated to neonatal intensive care and the acute care hospital community, announced FDA approval of its innovative second generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use with rebreathing anesthesia in the...

February 3, 2023

Diagnostics & Healthcare News

RefleXion Receives FDA Clearance for SCINTIX Biology-Guided Radiotherapy; Cutting-edge Treatment Applicable for Early and Late-stage Cancers

RefleXion Medical, a therapeutic oncology company, announced the U.S. Food and Drug Administration (FDA) has granted the first marketing clearance for its SCINTIX™ biology-guided radiotherapy, a cutting-edge treatment applicable for early and late-stage cancers. The company will host a live-stream event...

February 3, 2023

Orthopedics and Spine

Tyber Medical LLC Acquires ADSM-Synchro Medical

Tyber Medical LLC has acquired 100 percent of the capital of ADSM-Synchro Medical, a French orthopedic medical device company, specializing in the development and distribution of implants dedicated to treating surgical forefoot pathologies. Founded in 2010, ADSM has become a...

February 2, 2023