FDA clearance

By Dave Muoio November 8, 2018
Clinical diagnostic and workflow software maker MaxQ AI has received FDA 510(k) marketing clearance for Accipio Ix, an artificial intelligence workflow tool designed to help clinicians prioritize adults patients likely presenting with acute intracranial hemorrhage. The company received notification from the FDA of its decision in late October. Results generated by the algorithm-based software are...
By Dave Muoio October 31, 2018
Yesterday afternoon the FDA announced that it would permit 23andMe to market its Personal Genome Service Pharmacogenetic Reports test. The test offers consumers information on whether they posses one of 33 variants across multiple genes that could impact their body’s ability to metabolize certain medications. The purpose of this test is to inform patients and encourage them to more thoroughly...

Photo credit: Novarad

By Laura Lovett 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 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 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 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 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 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 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 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...