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...
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...
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...
U.K.-based digital health tech company Huma has received FDA 510(k) Class II clearance for its configurable disease-agnostic Software as a Medical Device platform, which includes the company's cardiovascular risk score algorithm.
The company, which received EU MDR Class IIb certification just three months ago, obtained FDA clearance in partnership with Health Canada through the FDA's joint eStar...
Italy-based healthcare agency, consultancy and digital health group, Healthware, and the Digital Therapeutics Alliance, a nonprofit organization based in Virginia that provides thought leadership and education to advance digital therapeutic adoption, today announced the release of a report outlining policy pathways for digital health adoption in Europe.
Alberta Spreafico, managing director of...
Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test.
The Cue COVID-19 Molecular Test detects genetic material from the SARS-CoV-2 virus. It consists of a nasal swab, or Cue Sample Wand, and a Cue Cartridge Reader. After taking the test, adults with respiratory infection symptoms receive the...
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