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FDA Updates

FDA In Brief: FDA Takes New Steps Aimed at Advancing Development of Individualized Medicines to Treat Genetic Diseases

This field is rapidly evolving, and antisense oligonucleotide drugs are the most advanced in this space

Revival Health Inc. Announces 9 Mil FDA EUA Authorized COVID-19 Rapid At-home Tests

Revival Health Inc. (Revival), a leading global medical device...

ImmersiveTouch Wins FDA Clearance For New Suite of Medical Diagnosis and Treatment Planning Tools

ImmersiveTouch’s COO, Jay Banerjee says, “adding this additional FDA 510(k) Clearance for medical diagnosis and treatment planning to our portfolio just strengthens what ImmersiveTouch can offer surgeons.”

Cardiologs’ AI Receives 510(k) Clearance for Pediatric Use

The new model, now supported by more than 20 million EKG recordings, was used to evaluate a global sample of 10,000 EKG readings from patients in various age groups.

FDA Expands Eligibility for COVID-19 Vaccine Boosters

"The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older," said Peter Marks, M.D., Ph.D.,

Blackrock Neurotech’s MoveAgain Brain-Computer Interface System Receives Breakthrough Device Designation from the FDA

The FDA Breakthrough Device designation aims to expedite the review of innovative technologies that can improve the lives of people with irreversibly debilitating diseases or conditions.

Avinger Announces FDA Clearance of Pantheris for the Treatment of In-Stent Restenosis

"We are excited to receive FDA clearance for the ISR indication, which expands our addressable market for Pantheris to include a high-incidence disease state for which there are few available indicated treatment options," commented Jeff Soinski, Avinger's President and CEO.

Advantis Medical Imaging Receives FDA Clearance for Brain MRI Analysis Software

Brainance MD™ is currently in use in Europe as a CE Marked device where numerous clinical organizations have integrated it in their daily clinical brain MRI processing workflows. With this first FDA clearance the company aims to collaborate with U.S. clinicians by assisting them to focus on clinical findings and save valuable time.

Philips Advances Ultrasound Portfolio with New Robust Imaging Tools & Features for Radiology to Increase Diagnostic Confidence and Workflow Efficiency

Philips will debut its Liver Fat Quantification solution at the Radiological Society of North America (RSNA) Annual Meeting later this month.

GE Healthcare Receives FDA Clearance for First X-ray AI to Help Assess Endotracheal Tube Placement

The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

Medtronic Reports 510(k) Clearance for PillCam™ Small Bowel 3 @HOME Endoscopy Procedure

PillCam SB3 @HOME provides a telehealth option for direct visualization and monitoring of the small bowel, to help better detect lesions not detected by upper and lower endoscopy that may: 1) indicate Crohn's disease, 2) locate obscure bleeding, or 3) identify sources of iron deficiency anemia (IDA).

HeartVista Receives FDA 510(k) Clearance to Deliver One Click MRI™ on Siemens Healthineers MRI Scanners

HeartVista, a pioneer in AI-assisted MRI solutions, today announced...
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