Search Tag: FDA

2023 21 Sep

Elon Musk's controversial biotechnology startup, Neuralink, announced that they have received approval from the independent institutional review board to commence recruitment for its first-in-human clinical trial. The P recise R obotically Im planted Brain-Computer Interfac e (BCI) (PRIME study) will investigate brain implants in individuals suffering...Read more

2019 26 Mar

The U.S. Food and Drug Administration (FDA) recently released its draft guidance on managing cybersecurity in medical device premarket submissions. In the draft, a two-tiered system for identifying cyber risk is proposed, with higher risk devices falling into Tier 1 while other devices would be of “Standard Cybersecurity Risk” or Tier 2....Read more

2017 02 Jan

Amid criticism that it was not doing enough to address the cyber vulnerabilities in medical devices, the U.S. Food and Drug Administration has issued guidelines on how manufacturers can protect their products against cyberattacks. According to the guidelines, manufacturers must build cybersecurity controls into medical devices during the development...Read more

2015 10 Aug

The U.S. Food and Drug Administration has approved the first 3D-printed drug, SPRITAM ® , for oral use as a prescription adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures and primary generalised tonic-clonic seizures in adults and children with epilepsy.   The FDA approval is being hailed as a breakthrough in precision...Read more

2015 29 Jan

Dexcom, Inc. (San Diego, CA) has become the first company to obtain U.S. Food and Drug Administration (FDA) pre-market approval for its mobile apps to support continuous glucose monitoring. The new apps are intended to make it easier for care managers and loved ones to closely monitor glucose levels to avoid complications, such as hyperglycaemia, which...Read more

2014 06 Oct

The US Food and Drug Administration (FDA) has announced a new guidance for medical device manufacturers with regard to managing cybersecurity risks to better protect patient health and information. The federal agency noted that some medical devices and computer systems can be vulnerable to security breaches, potentially impacting the safety and effectiveness...Read more

2014 29 Jul

An under-regulated mobile health industry could create “a Wild West” market, says law professor, Nathan Cortez, writing in the New England Journal of Medicine. Cortez, who has conducted extensive research into FDA regulation of mobile health technologies argues that while mHealth holds great promise, there is a role for government oversight. Out of...Read more