FDA clearance

Photo credit: Novarad

By Laura Lovett 03:17 pm October 29, 2018
The possibilities of Microsoft’s HoloLens system have become a hot topic in the medical world in recent years. But last week Novarad’s OpenSight Augmented Reality System received FDA clearance for pre-operative surgical planning using the tech company's augmented reality headset. The newly FDA-cleared system uses the lens to project 2D, 3D and 4D interactive images onto a patient’s body during...
By Dave Muoio 11:42 am October 10, 2018
Last week FibriCheck announced that it received FDA 510(k) clearance for its app, which uses a smartphone’s camera and artificial intelligence to monitor for heart rhythm disorders. With this, the Belgian company expects to bring its product to the US market sometime in 2019. To identify atrial fibrillation, FibriCheck monitors the user's heart rhythm via photoplethysmography. From there, an...
By Laura Lovett 08:24 am October 9, 2018
Bethesda, Maryland-based startup RightEye has just scored FDA 510(k) clearance for its cloud-based eye-tracking system and software. The technology was designed to help clinicians identify visual tracking impairments in patients by recording, viewing and analyzing a patient’s eye.  The system has four main target areas: functional vision screening, reading assessments, sports vision assessment...
By Laura Lovett 02:51 pm September 12, 2018
Yesterday physIQ announced that the it got the FDA nod for its latest product, an atrial fibrillation detection analytics engine designed to be used in both a patient care setting and in clinical trials. The system is intended to give further clinical insights about patients' atrial fibrillation, and will work with the company’s other products already approved to provide data analyses.  “Since...
By Laura Lovett 11:20 am September 10, 2018
Furthering its move into the neonatal space, this morning non-invasive patient monitoring device and sensor maker Masimo announced that it landed FDA clearance for its acoustic respiration sensor, the RAS-45, to be used with infants and neonatal patients as part of its Rainbow Acoustic Monitoring (RAM) system.  Previously, the company's RAS-45 and RAS-125 sensors were cleared for adults and...
By Dave Muoio 03:33 pm August 10, 2018
The FDA announced today that it will allow marketing of Natural Cycles’ contraception app in the US for pre-menopausal women aged 18 years and older. Previously approved in the UK and currently the subject of investigation by multiple regulatory agencies, the algorithm-driven app helps users track their menstrual cycle and informs them when they are most fertile. “Consumers are increasingly using...
Adherium receives additional FDA clearance for OTC sale of inhaler sensors in the US

Credit: Adherium on Twitter

By Dave Muoio 02:36 pm July 27, 2018
Connected inhaler sensor maker Adherium has received 510(k) clearance for US over-the-counter sales of its Hailie sensor, formerly known as Smartinhaler. Specifically, individual versions of the device have been cleared for use with the asthma inhalers ProAir HFA, Ventolin HFA, and Flovent HFA. “This latest clearance kicks off our official entry into the US consumer market, giving the tens of...
By Dave Muoio 04:00 pm July 11, 2018
Kibbutz Shefayim, Israel-based deep learning startup Zebra Medical Vision announced that it has received FDA 510(k) clearance for an algorithm that helps physicians quantify a patient’s coronary artery calcification. From a ECG-gated computed tomography (CT) scan, the Coronary Calcium Scoring algorithm automatically calculates a calcification rating equivalent to those derived using the Agatston...
By MobiHealthNews 04:11 pm July 5, 2018
Interest in digital health is now sprouting up all over DC, from the president’s announcement of a new AI task force to FDA Commissioner’s shout out to digital health in his budget request.   In fact, the FDA is turning to developers in the digital health space to help solve some of the country’s most difficult problems. In May, the agency announced an innovation challenge aimed at tackling the...
By Laura Lovett 11:11 am June 22, 2018
Children with Type 1 diabetes will now have access to the Medtronic MiniMed 670G, a hybrid closed-loop system insulin delivery system, following the FDA’s decision to expand the product approval for a younger demographic.  In 2016 the device became the first FDA-approved continuous glucose monitoring system that controls automated insulin delivery via a hybrid closed loop system. But at that time...