Medtronic launches bariatric surgery tool to enable more consistent procedures

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.

Hospitals tell feds that they can do more to support unique device ID

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.

JAMA: Astute Medical Dx assists in acute kidney injury prevention

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.

FDA to allow midstream changes to device trials as part of effort to speed up approvals

The FDA continued its focus on improving the clinical trial paradigm with this week’s issuance of a draft guidance on adaptive designs for medical device clinical studies.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.

In new guidance FDA says it may approve devices for use by certain subpopulations only

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.