Regulation

Two people walking through a federal building while talking to each other
By  Jessica Hagen 04:35 pm December 29, 2023
Federal agencies like the FDA and HHS have established safety programs to ensure safe and trustworthy artificial intelligence use in various sectors, including healthcare.  Digital health executives relayed their recommendations, advice, and suggestions for regulators configuring rules around AI use in healthcare to MobiHealthNews, including flagging AI-generated content and building off existing...
Jay Rughani, investment partner at Andreessen Horowitz
By  Jessica Hagen 12:41 pm December 26, 2023
Note: Andreessen Horowitz says views expressed by its employees are their own and should not be taken as investment advice. More details at https://a16z.com/disclosures/. As 2023 comes to a close, Jay Rughani, investment partner at Andreessen Horowitz, joined MobiHealthNews to discuss his takeaways from the year, noteworthy events, recommendations for regulators forming rules around AI in...
Healthcare provider listening to a person's stomach using a stethoscope
By  Jessica Hagen 04:02 pm December 8, 2023
At-home fertility care company Mosie Baby announced it received FDA 510(k) clearance for the first over-the-counter intravaginal insemination (IVI) kit, which allows individuals to perform at-home insemination using either a fresh or cryogenically frozen donor semen sample.  Mosie's home insemination kit includes two syringes with a barrel-free tip and a slit opening, as well as two collection...
Dr. Michael Howell, chief clinical officer at Google
By  Jessica Hagen 02:41 pm December 5, 2023
Dr. Michael Howell, chief clinical officer at Google, sat down with MobiHealthNews to discuss noteworthy events in 2023, the evolution of the company's LLM for healthcare, called Med-PaLM, and recommendations for regulators in constructing rules around the use of artificial intelligence in the sector.  MobiHealthNews: ​​What are some of your big takeaways from 2023? Dr. Michael Howell: For us,...
Person putting a hearing aid in their ear
By  Nathan Eddy 05:24 pm November 7, 2023
Soundwave Hearing announced it has received FDA 510(k) clearance for its Sontro Self-Fitting OTC Hearing Aids, which blend mobile technology and artificial intelligence calibration capabilities to self-fit and amplify sound for individuals aged 18 and older with mild to moderate perceived hearing impairment. The Sontro hearing aids allow for personalization using AI technology to tailor the...
Food and Drug Administration Building
By  Jessica Hagen 11:18 am September 15, 2023
On Thursday, the FDA Center for Devices and Radiological Health released updated final guidance for its Breakthrough Devices Program, aimed at verifying medical devices on the market are safe and effective, and improve healthcare inequities.  The final guidance defines the FDA's interpretation of "more effective" as encompassing all the information about the device, including the risks and...
Patient sitting on the side of a bed in a hospital room wearing a hospital gown
By  Nathan Eddy 11:47 am August 16, 2023
GE HealthCare announced its smartphone-sized Portrait Mobile wireless monitoring solution has received FDA 510(k) clearance, clearing the path to the device becoming commercially available in the U.S. Designed for in-hospital use, Portrait Mobile aims to shift the paradigm from periodic spot checks to continuous vital sign monitoring for indications of patient decline while freeing the patient...