- groninger to Highlight Filling and Closing Unit Series for OTC Pharma and Diagnostics Products At Pack Expo
- Nuclera Closes $75 Million USD Financing
- Biocomposites Invests in InfectoTest GmbH | Developers of a Bacterial-specific Point-of-care Test for Periprosthetic Joint infection
- BD Announces New Robotics Solution to Automate, Standardize Single-Cell Research
- Penumbra Announces Completion of THUNDER IDE Study Enrollment for Acute Ischemic Stroke
- Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life
- Syncona: Resolution Therapeutics Raises £63.5 Million in Series B Financing | Appoints New Chair
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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Stimulating the Brain: Here’s How You Can Cope With Depression
tDCS devices aren’t a replacement for mental health professionals or pharmaceuticals. Still, they’re medically-approved devices (in most instances) that can alleviate symptoms of depression and allow many to cope on a day-to-day basis.
Eyenuk Secures European Union Certification for Autonomous AI-Powered Detection of Age-Related Macular Degeneration and Glaucoma
“Achieving MDR certification is another major milestone for Eyenuk and a result of our early adaptation to the more stringent requirements of the new regulation,” said Kaushal Solanki, Chief Executive Officer and Founder of Eyenuk. “Moreover, this certification expanding our ability to market the EyeArt platform for two additional disease conditions in the EU reflects the flexibility of our AI-based platform and the depth of the clinical research conducted across the globe validating its effectiveness.”
CEYEBER Develops First-Ever Intraocular Smart Lens: The Third Eye
“We’re very excited about our revolutionary solution for age related macular degeneration (AMD), accommodative vision correction and the long-term prevention of blindness. According to recent estimates, close to 200 million people globally are affected by AMD which is expected to grow to 288 million people by 2040. CEYEBER will have a profound impact on the quality of life and vision for millions of people worldwide,” explained Robert Edward Grant, Founder and CEO of CEYEBER.
MicroTransponder Secures CMS Transitional Pass-Through Status & New Technology Add-On Payment for Its Breakthrough Stroke Rehabilitation System, Vivistim
The Vivistim Paired VNS System is an FDA Breakthrough Device that was granted pre-market authorization (PMA) approval on August 27, 2021. Unlike other neurostimulation technologies, the Vivistim System is used in conjunction with rehabilitation therapy to help ischemic stroke survivors who have chronic arm and hand deficits improve their upper limb function.
Clinical Trials
Ra Medical Systems Announces the Presentation of Clinical Data at the European Heart Rhythm Association Congress
David Jenkins, Ra Medical Systems Executive Chairman. “All four abstracts with VIVO clinical data submitted by leading physicians to the Congress were accepted for presentation following an extensive peer-review process. To have one-hundred percent acceptance of submitted abstracts is rare and I believe indicative of the positive impact VIVO is having on ventricular ablation procedures. We view this recognition as a major milestone in gaining clinical acceptance by both EP thought leaders and the larger medical community.”
New Study Shows Vasc-Alert Surveillance Technology Successfully Predicts Vascular Access Blockages in Dialysis Patients
Vasc-Alert, a pioneer in vascular access surveillance, today announced the publication of a study in the Journal of Vascular Access validating its Vasc-Alert surveillance technology
Delcath Systems Announces Updated Results from CHOPIN Phase 1b Trial Published in Cardiovascular and Interventional Radiology
Updated results from the CHOPIN Phase 1b Trial in seven patients with advanced uveal melanoma treated with CHEMOSAT and ipilimumab plus nivolumab show a Median PFS of 29.1 months
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Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace
FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements
Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
The field of regenerative medicine may be on the cusp of an evolution, and due to the unique attributes of skin and wounds, the largest organ in the body may be emerging as a leader
FDA Medical Device Updates
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