FDA Finalizes Guidance on Interoperable Devices

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

The guidance, first drafted in January 2016, is meant to assist manufacturers and FDA staff in identifying considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information from devices.

It also features help for companies designing and developing interoperable medical devices, and recommendations regarding information to include in device labels and premarket submissions...

Latest news

Italy -
Boston Sci Employee Found Guilty in Criminal Case

Boston Sci is looking at $1M in fines from Italian court in relation to one of its employees financing unauthorized clinical trials. Boston Scientific faces $1 million in fines after an Italian court found one of its employees guilty in a criminal case, according to an SEC filing . On Feb. 23, 2015, the judge for the Court of Modena (Italy) ordered a trial for the Marlborough, MA-based company and three of its employees as well as numerous other defendants charged in criminal proceedings. Those charges arise from allegations that the defendants made improper donations to certain healthcare...

Discovery -
3D Printed Clip Turns Smartphone into Powerful Microscope

Modern smartphones feature incredible image sensors that are much better than professional equipment from only a few years ago. They’re great for microscopy and simple attachments in front of the lens can give great views of blood, cells, and other specimens. The only problem is that the sample has to be illuminated and having LEDs inside of smartphone clip-on microscopes made them quite large . Now engineers at the ARC Centre of Excellence for Nanoscale BioPhotonics in Australia have developed a clip-on dongle that uses the phone’s built-in light, or even the sun, to bathe the samples in...

Discovery -
Placenta-on-a-Chip to Screen for Drug Safety During Pregnancy

Researchers at the University of Pennsylvania have developed a microfluidic chip that mimics the placental barrier. Their device paves the way for drug screening to determine which drugs can cross the placental barrier, allowing researchers to assess drug safety for pregnant women. Pharmacological treatment for pregnant women can be risky, as some drugs can cross the placental barrier and could potentially affect the fetus. Researchers don’t yet fully understand how the placenta permits some molecules to pass through it, and blocks the passage of others...



Make sure you don't miss latest news, stay tuned!