FDA clearance

By Dave Muoio January 10, 2019
The FDA has granted 510(k) clearance to an over-the-counter handheld electronic device for treating hay fever sinus pains, according to an announcement from its manufacturer. Tivic Health Systems’ ClearUP Sinus Pain Relief device is non-invasive and does not rely on a pharmacological component. Instead, the single-button device is run along the skin of the user's cheek, nose and brow, where it...
By Dave Muoio December 18, 2018
The FDA has approved an app-based smart programming device used to discreetly and easily control implants treating for overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention, medical device maker Medtronic announced yesterday. Called the InterStim smart programmer and designed for use with Medtronic’s InterStim system, the product consists of a Samsung...

Photo credit: POPS! Diabetes Care

By Laura Lovett December 10, 2018
Last week, the FDA granted a 510(k) clearance to POPS! Diabetes Care for its latest product, the POPS! one blood glucose monitoring system.  The system is made up of a diabetes coaching app and a small glucose meter that attaches to the back of a user’s smartphone. Users can check their glucose levels on the meter and the results will automatically transfer to the app. Users can track their...
By Dave Muoio November 28, 2018
Basking Ridge, New Jersey-based medical device maker Electrocore has received a 510(k) clearance expanding the label of its non-invasive vagus nerve stimulator (VNS) therapy device to include cluster headache prevention. According to a release from the company announcing the news, no other devices or pharmacologic treatments have received this indication from the agency. Therapy using the...
By Dave Muoio November 15, 2018
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the...
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...

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