A recent webinar sponsored by Formlabs underscored the value of 3D printing from a clinical perspective and offered insight on how commercial and regulatory players are thinking about this space.
The report found that nearly 73,000 people on Medicare had one of the seven devices replaced because of recalls, premature failures, medically necessary upgrades or infections.
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Vivex Biologics is in the midst of raising a $10 million round to support its advanced tissue and bone implants.
"Cyborg brains," in the form of brain implants, are in development at the University of Southern California.
The FDA finally made its final unique device identifier rule this week, but the document is thousands of pages long. Jay Crowley, senior adviser of patient safety at the FDA, highlighted seven of the big changes medical device manufacturers should note from last year’s draft to the final. Here they are in laymen’s terms. 1) […]
If perception is reality, reality might be about to get quite a bit more intense: Super-senses are no longer just for Peter Parker and Clark Kent. A Duke University study published in Nature Communications shows with a brain implant and some training we may be able to significantly enhance sight, hearing and taste in mammals. Researchers […]
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
Medtronic makes history in neurostimulation devices today, receiving FDA-approval for the first implantable spinal cord stimulation systems for use in the treatment of back pain for conditionally safe full-body MRI under specific conditions. Its RestoreSensor® SureScan® MRI neurostimulation systems will allow patients with the implant to undergo an MRI, previously impossible due to the magnetic fields […]