Regulation

By Laura Lovett 01:08 pm July 6, 2020
Abbott’s Bluetooth connected cardioverter defibrillator and cardiac resynchronization therapy defibrillator, part of the Gallant product line, scored FDA clearance this morning. Patients using the technology can connect it to a smartphone app, called MyMerlinPulse, which will let both patients and providers see transmission history and device performance. The app is also designed to nudge...
By Dean Koh 03:17 am July 2, 2020
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...
By Dave Muoio 11:08 am June 26, 2020
London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to measure respiration rate via radar in adult patients up to four feet away. Circadia said in its announcement that the C100 system will be launching "immediately" in light of the high demand for respiratory-related illness management. The startup is aiming...
By Dave Muoio 05:39 pm June 15, 2020
After years of waiting, Akili Interactive has finally received FDA De Novo marketing authorization for EndeavorRx, its video-game digital therapeutic for children aged 8 to 12 years with ADHD. This is the first game-based therapeutic that the FDA has greenlit for any condition, the regulatory agency noted in its announcement. It is also the first authorization for Akili, which has a handful of...
By Laura Lovett 03:15 pm June 15, 2020
This morning Abbott revealed that its much anticipated integrated continuous glucose monitoring system the FreeStyle Libre 2 is now FDA cleared for adults and kids over the age of 4 with diabetes.  The latest product is able to continuously transmit glucose data every minute, and users can set the system to send alarms when their glucose is too high or too low. Previously users had to scan the...
By Laura Lovett 12:08 pm June 12, 2020
Royal Philips joins the list of companies taking advantage of the relaxed FDA guidelines with its plans to launch its prenatal monitoring platforms in the U.S.  The Fetal and Maternal Pod and Patch will be able to continuously monitor both the maternal heart rate and fetal heart rate, as well as uterine activity, with a dispensable electrode patch. The tech is intended for high-risk pregnancies....
By Laura Lovett 03:53 pm May 14, 2020
Early this week cardiac-focused digital health company Eko scored a temporary Emergency Use Authorization (EUA) for its ECG low ejection fraction tool, which can be used to help clinicians spot cardiac complications associated with the novel coronavirus. Providers are able to use the tool in order to get an assessment of Left Ventricular Ejection Fraction, a measure which providers can use to...
By Laura Lovett 02:00 pm May 6, 2020
This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment of the brain.  Named Nurochek, the system uses Visual Evoked Potential (VEP) in order to gauge brain health. When a user puts on the headgear, which includes a set of goggles, the system presents visual stimulus to the brain. As this process is taking place...
By Dave Muoio 03:28 pm May 5, 2020
The FDA has granted an Emergency Use Authorization (EUA) to VitalConnect that allows its VitalPatch wearable sensor to further monitor patients undergoing COVID-19 treatment. As per the agency's letter of authorization, providers may use the remote-monitoring device in a hospital setting to spot changes in patients' QT interval, which may be dangerously prolonged by experimental drug treatments...
By Laura Lovett 03:41 pm April 30, 2020
In many ways’ tech has made the world smaller and more interconnected. Information that once took days to reach new countries now takes milliseconds. Digital health is also shaking up the way patients receive care globally, and how they expect to receive care.  “Our consumer expectations, our knowledge that what we are getting as a consumer in healthcare isn’t matching up to what we are getting...