medical device guru

Surgery and Surgical Robotics

Ultrasound-Guided Transcervical Fibroid Ablation System FDA Cleared 

Gynesonics, a women’s healthcare company focused on the development of minimally-invasive solutions for symptomatic uterine fibroids, today announced that it has received 510(k) clearance from the FDA to market its Sonata® Sonography-Guided Transcervical Fibroid Ablation (Sonata) System. The Sonata System...

August 24, 2018

Diagnostics & Healthcare News

Exact Sciences Signs Partnership with Pfizer to Market Cologuard Tests

Sales representatives of Pfizer Inc., the world’s largest pharmaceutical company, will join Exact Sciences Corp.’s sales representatives in selling the company’s non-invasive screening test for colorectal cancer to physicians and health systems under an agreement announced Wednesday. Pfizer will make...

August 23, 2018

Imaging Visualization & Navigation

FDA Clears UVision360 Office Hysteroscopy Device

Luminelle DTx Hysteroscopy System has received its 510(k) clearance from the FDA with a dual-indication for both hysteroscopy and cystoscopy.  The Luminelle DTx Hysteroscopy System is small, easy to use, cost effective and has the potential for an affordable, accurate...

August 22, 2018

Biologics, Wound Care, Infection Prevention

Avista to acquire Organogenesis

Avista Healthcare Public Acquisition Corp., a publicly traded special purpose acquisition company, and Organogenesis Inc., a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care, Surgical and Sports Medicine markets,...

August 20, 2018

Diagnostics & Healthcare News

FDA Clears Brainsway TMS System to Treat OCD

On Friday, the FDA said it granted de novo approval for Brainsway‘s deep transcranial magnetic stimulation system, now indicated for treating obsessive compulsive disorder. The TMS system uses magnetic fields to simulate nerves in the brain, and has been shown to...

August 20, 2018

Biologics, Wound Care, Infection Prevention

MolecuLight’s First-of-its-kind Handheld Wound Imaging Device Receives FDA De Novo Clearance

MolecuLight Inc. achieved a major regulatory milestone permitting expansion into the United States market. FDA has granted De Novo clearance for the ground-breaking wound fluorescence imaging device, the MolecuLight i:X. The device digitally captures and documents fluorescence information from wounds and surrounding tissue...

August 16, 2018

Cardiovascular / Cardiology

BioSig’s High-Fidelity Electrophysiology System Approved by FDA

BioSig Technologies, Inc. announced that the Company has received 510(k) clearance for its first product, PURE EP System, from the U.S. Food and Drug Administration (FDA). The non-invasive PURE EP System is a computerized system intended for acquiring, digitizing, amplifying,...

August 14, 2018

Surgery and Surgical Robotics

7D Surgical’s Cranial Machine-Vision Guided Surgical System FDA Approved

7D Surgical announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cranial Module.  This achievement is a crucial step in the commercial launch of 7D Surgical’s innovative Machine-vision Image Guided Surgery...

August 13, 2018

Orthopedics and Spine

Siemens & Nuvasive Partner on Spinal Surgery Workflow Development

NuVasive said last week it had inked a strategic partnership deal with Siemens Healthineers looking to develop and advance technology designed for minimally invasive spinal surgery. Through the deal, dubbed the Spine Precision Partnership, the companies will look to jointly advance their proprietary...

August 13, 2018