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, 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,...
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...
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...
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...
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...
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...
