FDA 510(k)

By Jonah Comstock July 25, 2018
Correction: Thanks to an eagle-eyed reader, this story has been updated to remove the claim that Dip.io is the first FDA-cleared smartphone urine test. We've reached out to Healthy.io for comment on this development and we'll update when we hear more. Tel-Aviv, Israel-based Healthy.io has secured FDA 510(k) clearance for Dip.io, a home-based urinalysis kit that turns a smartphone into a clinical-...
By Jonah Comstock June 22, 2018
At long last, Eversense, the implantable continuous glucose monitoring system from Senseonics, has received FDA clearance to be marketed in the United States. “The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “These technologies allow patients to gain better control over their...
By Jonah Comstock May 16, 2018
Cambridge, Massachusetts-based sensor maker MC10, known for its flexible and stretchable electronics, has received its first FDA 510(k) clearance for the BioStamp nPoint system. BioStamp nPoint is a more advanced version of the company's non-FDA cleared BioStampRC. "BiostampRC was primarily developed as an investigational tool, primarily used by academia, as well as by pharmaceutical companies,...
By Jonah Comstock February 9, 2018
Smart thermometer and connected health company Kinsa has launched a new wireless version of its device, called Kinsa QuickCare, after securing FDA clearance last month. “Partly, this is our response to the fact that the headphone jack is gone,” Kinsa CEO Inder Singh told Babyforyou.net.ua. “The first version of our stick was corded and connected to the headphone jack, so our answer to that is a...
By Jonah Comstock February 5, 2018
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone. The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription...
By Babyforyou.net.ua December 21, 2017
In 2017, Babyforyou.net.ua covered 51 devices that received clearance from the FDA. Along with a handful of diagnostic devices, disease management platforms, and novel monitors, this year boasted a few surprises from the agency, such as the approval of a direct-to-consumer genetic tests for disease risk and a purely digital intervention. The year also hosted its fair share of regulatory news and...
By Jonah Comstock November 16, 2017
Medical device software company Voluntis has received an updated FDA clearance (as well as an updated CE mark) for its Insulia app, a "digital companion" app for people with Type 2 diabetes. Insulia offers realtime basal insulin dose coaching, and the new clearance makes the app usable with two additional brands of insulin: Basaglar and Tresiba. The app had already worked for users of Lantus,...
By Laura Lovett November 16, 2017
A new product that allows surgeons to pre-plan endovascular treatment of cerebral aneurysms was recently cleared by the FDA. EndoVantages’ SurgicalPreview is a cloud-based computer modeling platform that lets surgeons upload individual patient’s CT scans and then creates a 3D model of the brain with anatomical measurements.  A cerebral aneurysm, which is a weak spot in the blood vessel of the...
By Jonah Comstock October 31, 2017
New York City and Guilford, Connecticut-based Butterfly IQ has received FDA clearance for an iPhone-connected portable ultrasound scanner that uses an easy-to-manufacture semiconductor chip rather than the piezoelectric crystals used by traditional ultrasounds. Because of the semiconductor chip, the device will be offered at a much lower price point than existing ultrasounds, including existing...
By Jonah Comstock June 8, 2017
iRhythm Zio is in many ways a poster child for a connected health company. The company, which makes a peel-and-stick patch for mobile ECG recording, is one of the few wearable medical device companies to go public, and few digital technologies have as soundly improved on the status quo as Zio has on the Holter monitor, a long-term legacy monitoring technology. There's only one problem with...
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