The most common weight-loss surgery is the sleeve gastrectomy, in which two-thirds of the stomach is removed to create a pouch that is roughly the size and shape of a banana without touching the intestines. Medtronic has come out with a surgical tool, the GastriSail gastric positioning system, that it says will enable surgeons to consistently size the pouch, as well as to decompress the pouch and test for leaks.
Stakeholders including the Mayo Clinic, American Association of Orthopaedic Surgeons and The Pew Charitable Trusts broadly approve of proposed federal electronic health record certification criteria that encourage the use of unique device identification data, but think the regulations can be made even more supportive of UDI.
A study in The Journal of the American Medical Association used its NephroCheck diagnostic of acute kidney injury (AKI) to demonstrate that the life-threatening condition can be kept in check by what’s known as remote ischemic preconditioning.
This centimeter-long lump of silicon could soon be inserted under your skin to measure the chemical make-up of your blood—then send the results straight to your phone.
Researchers have developed silicon chips that can be implanted in the brain and relay a person’s intentions into the movement of robotic prosthetics.
The FDA continued its focus on improving the clinical trial paradigm with this week’s issuance of a draft guidance on adaptive designs for medical device clinical studies. Similar to a prior guidance on the incorporation of patient preference data in clinical trials, the latest guidance should help companies perform trials faster, and signals greater flexibility on the behalf of the FDA. The Agency seeks to bring more trials stateside and approve medical technology at a quicker pace.
The Indian government is developing a system of medical device surveillance and adverse event reporting, dubbed the Materio-vigilance Programme of India.
After listening to the head of FDA’s device arm (CDRH), Dr. Jeff Shuren, speak at several conferences, certain lines become predictable and repetitive. One of them is a boast about the January 2015 approval of the Maestro Rechargeable System on the basis of a patient survey which found that the subjects had a higher risk tolerance than anticipated.