Blog
RSS FeedPosted by Michael Wonder on 02 Mar 2021
Cook Medical receives FDA breakthrough device designation for Zenith fenestrated+ endovascular graft
1 March 2021 - Cook Medical’s Zenith fenestrated+ endovascular graft product has received breakthrough device designation from the US FDA. ...
Posted by Michael Wonder on 02 Mar 2021
Anuncia receives FDA breakthrough device designation for ReFlow System Mini
2 March 2021 - Anuncia received U.S. FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of ...
Posted by Michael Wonder on 02 Mar 2021
Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH
1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 01 Mar 2021
Vetex Medical receives FDA clearance for Revene thrombectomy catheter
1 March 2021 - Patented dynamic cage technology designed to predictably remove wall-adherent clot in peripheral veins, such as deep ...
Posted by Michael Wonder on 01 Mar 2021
Vascular Graft Solutions wins FDA approval to Market the VIOLA clampless proximal anastomosis system for CABG
1 March 2021 - Vascular Grafts Solutions announced today receipt of marketing clearance from the FDA for the VIOLA, a new ...
Posted by Michael Wonder on 01 Mar 2021
FDA authorises first robotically assisted surgical device for performing transvaginal hysterectomy
1 March 2021 - The U.S. FDA has authorised marketing of the Hominis Surgical System, a new robotically-assisted surgical device that ...
Posted by Michael Wonder on 26 Feb 2021
FDA authorises marketing of novel device to help protect athletes’ brains during head impacts
26 February 2021 - Today, the U.S. FDA authorised marketing of a new device intended to be worn around the neck ...
Posted by Michael Wonder on 26 Feb 2021
Empirical Spine initiates PMA submission process for FDA approval of Limiflex for degenerative spondylolisthesis
25 February 2021 - The LimiFlex Paraspinous Tension Band is a new, investigational device designed as an alternative to spinal fusion ...
Posted by Michael Wonder on 25 Feb 2021
Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method
24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...
Posted by Michael Wonder on 24 Feb 2021
Locate Bio’s Chondro3 granted FDA breakthrough device designation
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
Posted by Michael Wonder on 24 Feb 2021
Inovise receives breakthrough device designation for novel non-invasive system to remotely monitor risk of decompensation in heart failure patients
23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...
Posted by Michael Wonder on 23 Feb 2021
FDA approves EndoClot Hemostat to manage GI bleeding
23 February 2021 - A unique product to rapidly and reliably control bleeding during GI procedures. ...
Posted by Michael Wonder on 22 Feb 2021
Piccolo Medical receives U.S. FDA clearance of its SmartPICC system for the positioning of peripherally inserted central catheters
22 February 2021 - Piccolo Medical announces that it has received FDA clearance of its SmartPICC System. ...
Posted by Michael Wonder on 18 Feb 2021
Additive Orthopaedics announces FDA approval of patient specific talus spacer, first approved in the U.S.
17 February 2021 - Company can now initiate commercial marketing, sale, and distribution of patient specific talus spacer implants. ...
Posted by Michael Wonder on 17 Feb 2021
Axonics receives FDA approval for third generation implantable neurostimulator
16 February 2021 - Axonics Modulation Technologies has received PMA supplement approval from the U.S. FDA for its third generation implantable ...