MedTech News
.................... by Andrew Celentano

Easee receives CE mark under MDR for online eye exam
Easee, a digital healthcare speicalist, has achieved the CE mark Class II under the new European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR) which the company says is the world’s first and only CE certified online eye exam with refraction capabilities.

Start-up receives fresh funding to advance robotic glove for rehabilitation
Bioliberty, a medtech start-up which has created a soft robotic glove to help rehabilitate stroke patients, has received almost half a million pounds of new funding to accelerate its product to market.

BD Launches Advanced Vascular Access Ultrasound System Designed to Improve Clinician Efficiency
SiteRite™ 9 Ultrasound System Delivers Enhanced Image Quality and Vessel Assessment Tools to Aid in First Attempt IV Insertion Success

Next-Generation Microcatheter for Embolic Agent Delivery Cleared by the FDA
The XO Cath microcatheter is designed to deliver new levels of trackability, torque response, and embolic compatibility for improved treatment delivery.

Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea
The clearance positions the company to offer an alternative to continuous positive airway pressure devices and neurostimulation implants.

Immune action at a distance
MIT and MGH researchers design a local, gel-based drug-delivery platform that may provoke a system-wide immune response to metastatic tumors.

University of Birmingham develops new diagnostic for traumatic brain injury
Researchers from the University of Birmingham have designed and developed a novel diagnostic device to detect traumatic brain injury (TBI) by shining a safe laser into the eye.

US FDA Grants the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study
The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure.