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 ...

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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 ...

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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 ...

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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. ...

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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.  ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method

24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...

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Locate Bio’s Chondro3 granted FDA breakthrough device designation

24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...

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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 ...

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