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Diagnostics & Healthcare News

Synchron’s Stentrode Brain-Computer Interface Receives Breakthrough Device Designation from FDA

Synchron, a neurovascular bioelectronics medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for Stentrode, a fully-implantable medical device that can translate brain activity or stimulate the nervous system from the inside...

August 31, 2020

Diagnostics & Healthcare News

Valencia Technologies Files Pre-Market Approval Application with U.S. FDA for eCoin Peripheral Neurostimulator

Valencia Technologies Corporation (“Valencia“), a private medical device company, today announced the filing of its pre-market approval (PMA) application of its eCoin® Peripheral Neurostimulator System for overactive bladder with the Food and Drug Administration (FDA). eCoin® is a first-in-kind neurostimulator providing intermittent...

August 24, 2020

Diagnostics & Healthcare News

Ceek Women’s Health Introduces Nella NuSpec, a Smarter Reusable Vaginal Speculum

Ceek Women’s Health, a groundbreaking women-led medical device company, is excited to announce its latest innovation, the Nella NuSpec Reusable Vaginal Speculum. The Nella NuSpec was developed in partnership with OBGYN providers and patients through an extensive 5-year R&D process. ...

August 17, 2020

Diagnostics & Healthcare News

MagVenture Receives FDA Clearance for OCD

FDA has cleared MagVenture TMS Therapy for adjunct treatment of Obsessive-Compulsive Disorder (OCD). This marks the second indication in the US for the Danish medical device company MagVenture who is already FDA cleared for the treatment of major depressive disorder....

August 14, 2020

Diagnostics & Healthcare News

Neurolief Wins FDA Breakthrough Device Designation for Wearable Neuromod for Depression

Neurolief, a medical neurotechnology innovator, today announces that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Relivion system, the first non-invasive multi-channel brain neuromodulation technology, for the treatment of major depression. A wearable device,...

August 11, 2020

Diagnostics & Healthcare News

eSight 4 Earns CE Mark Approval to Bring New Wearable Device to Europe

eSight, a cutting-edge vision enhancement platform, today announces it has received CE Mark approval for eSight 4, the company’s latest assistive technology device that’s clinically proven to significantly enhance vision for those living with low vision and legal blindness. The...

August 10, 2020

Diagnostics & Healthcare News

Philips Wins FDA Clearance for EMS Remote Monitoring and Defibrillation Solution

Royal Philips, a global leader in health technology, today announced the launch of its remote monitoring and defibrillator solution (Tempus ALS) for pre-hospital settings in the U.S. The solution is a complete end-to-end system that combines innovative hardware and advanced...

July 30, 2020

Diagnostics & Healthcare News

LifeSignals Wireless Medical Biosensor Receives FDA Clearance

LifeSignals Group, today announced USFDA 510(k) clearance has been received for their LifeSignals ECG Remote Monitoring Patch Platform. The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for the continuous...

July 21, 2020

Diagnostics & Healthcare News

UK Watchdog Skeptical of Stryker’s $4B Wright Medical Dea

The U.K. Competition and Markets Authority on Tuesday raised concerns that Stryker’s proposed $4 billion acquisition of Wright Medical Group could result in the medtech giant controlling 90% of Britain’s total ankle replacement prostheses market, leading to higher prices and less choice for hospitals and...

July 2, 2020