medical device guru

Cardiovascular / Cardiology

Vivasure Medical Announces FDA IDE Approval to Initiate U.S. Pivotal Study

Vivasure Medical® Limited (“Vivasure” or the “Company”), a company pioneering novel fully absorbable technology for percutaneous vessel closure, announced that the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) to advance the company’s PATCH Clinical Study,...

March 13, 2023

Surgery and Surgical Robotics

Aquablation Therapy is the first surgical robotics system to receive a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence

PROCEPT® BioRobotics Corporation today announced Aquablation Therapy received a MedTech Innovation Briefing (MIB) from the National Institute for Health Care Excellence (NICE), for benign prostate hyperplasia (BPH) in the United Kingdom. NICE has recognized Aquablation Therapy is as effective as transurethral resection of the...

March 9, 2023

Orthopedics and Spine

X-Bolt Orthopedics Announces FDA 510(k) Clearance for Pro-X1™ Trochanteric Nail

X-Bolt, an emerging innovator of orthopedic devices, is pleased to announce that its hip fracture solution, the Pro-X1 Trochanteric Nail, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pro-X1 will be X-Bolt’s flagship launch in the United...

March 7, 2023

Orthopedics and Spine

Shoulder Innovations Announces Oversubscribed $42 million Series D Financing

Shoulder Innovations Inc. (SI), a Grand Rapids, Michigan based leader in the shoulder replacement implant market, announced closing on an oversubscribed $42 million Series D financing. SI is a privately-held medical device company with a broad team of successful innovators in the shoulder space....

March 6, 2023

Cardiovascular / Cardiology

Live Remote Cardiac MRI Exam to Showcase Vista.ai’s Automated and Virtual Scan Capabilities at ACC.23/WCC

Vista.ai, a pioneer and leader in automated MRI solutions, today announced that Dr. Michael Salerno, Chief, Cardiovascular Imaging at Stanford Health Care, will conduct a live remote cardiac MRI (CMR) scan using the company’s One Click MRI™ software at the...

March 3, 2023

Biologics, Wound Care, Infection Prevention

Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® to Coagulate and Contract Soft Tissues

Apyx Medical Corporation (NASDAQ:APYX), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion...

March 2, 2023

Imaging Visualization & Navigation

SpectraWAVE Secures 510(k) Clearance of HyperVue™ Intravascular Imaging System

SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue™. The system combines next-generation...

March 1, 2023

Cardiovascular / Cardiology

ReCor Medical Announces Two Concurrent JAMA Network Publications of Study Results on the Paradise Ultrasound Renal Denervation System for the Treatment of Hypertension

ReCor Medical, Inc. (“ReCor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) today announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results...

February 28, 2023

Cardiovascular / Cardiology

Eko Launches SENSORA™ Cardiac Disease Detection Platform

Eko, a digital health company applying artificial intelligence (AI) in the fight against heart and lung disease, today announced the launch of the SENSORA™ Cardiac Disease Detection Platform. SENSORA™ currently features AI that objectively identifies structural murmurs, a sign of valvular...

February 24, 2023