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Tag: Breakthrough Device Designation

Endogenex™ Announces $88 Million Series C Financing to Complete Pivotal Trial of the ReCET™ System in Patients with Type 2 Diabetes | BioSpace

Medical Devices
Oversubscribed financing led by strategic investor, with participation from new and existing investors MINNEAPOLIS, June 25, 2024 /PRNewswire/ -- Endogenex, a clinical-stage medical device company...

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SetPoint wins second FDA breakthrough device nod for neurostim device

Medical Devices

Sooma raises $5.5m to expand access for neuromodulation device

Medical Devices

Saranas debuts data for early bird bleed monitoring system  

Medical Devices

Helsinki-based Sooma secures €5 million to brain stimulate yourself out of depression from home | EU-Startups

Startups
Sooma Medical, a leading provider of effective brain stimulation treatments for psychiatric and neurological disorders, announced its new growth funding of €5 million. The...

ONWARD® Medical Accepted to New US FDA TAP Program for Development of its ARC-BCI™ System | BioSpace

Medical Devices
The Company is one of the first brain-computer interface entrants accepted into this program, intended to optimize the commercialization pathway for breakthrough medical technology EINDHOVEN,...

FDA approves Boston Scientific’s drug-coated balloon

Medical Devices

SeaStar’s device granted humanitarian exemption approval for children with AKI

Medical Devices

Curavit Successfully Completes a Virtual Clinical Trial for Sana’s Investigative Digital Therapeutic to Treat Symptoms of PTSD | BioSpace

Medical Devices
NEW YORK, Feb. 12, 2024 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for...

CVRx Announces Appointment of Kevin Hykes as President and Chief Executive Officer | BioSpace

Medical Devices
Appointment effective February 12 following Nadim Yared’s retirement Hykes currently serves as Augmedics’ President and CEO, and has served on CVRx’s Board of Directors...

Geneseeq scores FDA breakthrough designation for cancer detection device

Medical Devices

SpineX’s neuromodulation device shows improvement in adult cerebral palsy

Medical Devices

FDA grants breakthrough device designation for Renovos’ bone graft gel 

Medical Devices
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