Blog
RSS FeedPosted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
MedAlliance receives fourth FDA breakthrough device designation for sirolimus drug eluting balloon in treatment of de novo coronary lesions
4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...
Posted by Michael Wonder on 03 Mar 2021
Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine
2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...
Posted 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 ...