Digital chronic care company Welldoc has received its ninth FDA 510(k) clearance for its diabetes management platform BlueStar.
The new clearance, which was announced by Welldoc Wednesday, but approved by the FDA earlier this month, expands its earlier approval for insulin dosing support to include bolus and premixed insulin titration for Type 2 diabetes.
The Insulin Adjustment Program with...
RapidAI, a health tech company specializing in stroke imaging, has received clearance from the FDA for its Rapid ASPECTS neuroimaging analysis device.
The product was designed to improve physicians’ interpretations of Non-Contrast CT (NCCT) scans using the automated ASPECT score, according to the company. It uses the Alberta Stroke Program Early CT Scoring (ASPECTS) and machine learning to come...
Mumbai-based healthcare AI startup Qure.ai earlier this week announced its first US FDA 510(k) clearance for its head CT scan product qER. The US Food and Drug Administration’s decision covers four critical abnormalities identified by Qure.ai’s emergency room product.
The AI tool can now be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures...
Look to the skies. A recent report by Nesta, a global innovation foundation, conducted in collaboration with five UK cities suggests that no small number of regulatory and infrastructural obstacles stand in the way of medical drone deliveries in the country. While the technology could increase the testing speed and decrease costs for the UK’s National Health Service, the country would need to...
Carestream has received FDA clearance for VUE Motion, a mobile radiology viewing and reading software that can be accessed on iPhone 4s, iPad 2, Galaxy Note and Galaxy S III mobile devices. Notably, the clearance allows radiologists to read, not just view the images, which means they can make clinical reports based on them.
"If a radiologist has access to other workstations, we recommend that...
Departing national health IT coordinator Dr. Farzad Mostashari would prefer that the Food and Drug Administration unilaterally issue a long-anticipated final guidance on mobile medical apps rather than waiting for inter-agency consensus with the Federal Communications Commission and Mostashari's own Office of the National Coordinator for Health Information Technology.
"I testified before Congress...
The FDA has granted Class II prescription-only 510(K) clearance for an iPhone-enabled vision test. The software, called myVisionTrack, was developed by Vital Art and Science. The FDA clearance applies to the software when run on an iPhone 4S.
Vital Art and Science has developed the test for patients with serious degenerative eye conditions such as diabetic retinopathy (DR) and age-related macular...
MIM Software received its second FDA 510(k) clearance this week for the latest version of its Mobile MIM radiology app. The newest FDA clearance adds support for viewing images to plan for a radiation-based treatment.
Mobile MIM is used to view high resolution diagnostic X-ray and ultrasound images downloaded from either MIM's MIMcloud cloud-based service or a workstation. With the app's latest...
GE Healthcare's Centricity Radiology Mobile Access 2.0 app received FDA (510k) clearance this week, the company announced in a press release. The mobile imaging application is a free download for Apple iOS devices and is cleared for remote viewing of computed tomography and magnetic resonance exams.
Centricity Radiology Mobile Access 2.0 accesses images and reports from the Centricity PACS (...
Amcom Software announced this week FDA 510(k) clearance for its Amcom (Commtech) Messenger middleware as a class II medical device intended for hospital use.
The Amcom Messenger middleware sends critical secondary notifications from patient monitoring and other alert systems to staff carrying wireless communication devices, including smartphones, pagers, and Wi-Fi phones.
"Systems like this --...
