2015 Clinic Manufacturing Provider 
The Medical Futurist
JUNE 17, 2025
Artificial intelligence Already, dentists employ software to get insights into clinical decision-making, but AI is changing the face of dentistry, just like it is in many other fields. Smart toothbrush While AI helps dental professionals provide better treatments, smart toothbrushes enable all of us to take better care of our teeth.
The Medical Futurist
JUNE 21, 2025
In 2015, surgeons in Manchester, UK have performed the first bionic eye implant for an AMD patient using Second Sight’s innovation. Researchers say that the implant cannot provide any highly detailed vision – but it can help patients detect distinct patterns such as door frames and shapes. That must have been truly amazing!
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FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
FDA Law Blog
MARCH 8, 2023
Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format.
FDA Law Blog
SEPTEMBER 26, 2024
What no one should find funny is how CDRH seems to be approaching Breakthrough devices of late, setting clinical study expectations so high that these innovative, novel, life-saving products may never get to the other side of the door, regardless of how much they knock. The Breakthrough program started in 2015.
GeriPal
MARCH 2, 2023
By 2015 that number increased to 4% of US adults. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? I understand that it can be a hard place clinically. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin).
FDA Law Blog
APRIL 7, 2025
Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.
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