Regulation

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...
Three healthcare providers in scrubs performing surgery on a patient
By  Jessica Hagen 04:22 pm July 17, 2023
MediView XR, a medtech company utilizing augmented reality, announced it received FDA 510(k) clearance for its AR surgical navigation system dubbed XR90. XR90 is an augmented reality visualization and surgical navigation platform that allows providers to see a patient's internal soft tissues, vascular, organ and skeletal structures in 3D based on their CT images.  It also combines CT imaging with...
Two healthcare providers looking at a brain scan
By  Jessica Hagen 11:57 am July 3, 2023
Belgium-based brain imaging AI company icometrix announced it received a CPT III code from the American Medical Association enabling reimbursement of its FDA-cleared brain MRI quantification software.  icometrix AI-supported quantitative brain analysis software provides metrics for cerebral MRI scans to help clinicians diagnose, monitor and evaluate treatment responses in patients with...
One person holding a baby while lying down with another person looking over their shoulder at the baby
By  Jessica Hagen 01:57 pm June 20, 2023
Owlet, a tech company focusing on smart baby monitoring, received FDA clearance for its medical pulse oximetry wire-free sock for infants dubbed BabySat.  BabySat uses pulse oximetry technology to monitor a baby's heart rate and oxygen saturation level and alerts caregivers when a reading is outside of prescribed ranges. The company says the device is for use per a healthcare provider's...
Person using a virtual reality headset while holding their hands up in front of them
By  Jessica Hagen 12:26 pm June 14, 2023
Boston-based virtual reality platform XRHealth announced it was awarded a U.S. patent for a learning system technology that adjusts training and treatment protocols according to a patient's biometric and motion data.  XRHealth's platform allows patients on the autism spectrum and those with stress, anxiety, chronic pain, fibromyalgia and neurological conditions to connect with a provider via...