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Diagnostics & Healthcare News
Fitbit Wins FDA 510(k) Clearance and CE Mark for ECG App
Fitbit has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE)marking in the European Union, for its electrocardiogram (ECG) app to assess heart rhythm for atrial fibrillation (AFib), a condition that affects more than...
September 14, 2020
Diagnostics & Healthcare News
AdvaMed Commends Proposed CMS Rule to Cover “Breakthrough” Medical Devices
Following today’s issuance by the Centers for Medicare and Medicaid Services (CMS) of a proposed rule on Medicare coverage of innovative technologies, the Advanced Medical Technology Association (AdvaMed) issued the following statements from President and CEO Scott Whitaker and other...
September 1, 2020
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
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