FDA 510(k)

By Dave Muoio 01:40 pm January 27, 2020
Abbott’s Infinity Deep Brain Stimulation (DBS) system has received an expanded clearance from the FDA that now permits the targeted stimulation of a new area of the brain associated with Parkinson’s disease symptoms. By now targeting the internal globus pallidus alongside the subthalamic nucleus and ventral intermediate nucleus, the company says that its system “is now the only directional DBS...
By Laura Lovett 03:16 pm January 23, 2020
Wearable sensor company VivaLNK got the FDA nod for its Multi Vital ECG Sensor and software development kit (SDK) this morning.  This comes roughly a month after the technology landed a CE Mark, allowing the product to be marketed in the European Union.  The new product, which includes a light weight reusable sensor and corresponding SDK, allows developers and providers to have direct control...
By Dave Muoio 11:13 am January 22, 2020
Editor's note: This story has been updated with information from Verily's announcement of the clearance.  Verily, the life sciences research subsidiary of Alphabet, has received FDA 510(k) clearance for an augmented version of its prescription Study Watch wearable that includes some form of arrhythmia monitoring. The Study Watch With Irregular Pulse Monitor is classified by the FDA as a “...
By Dave Muoio 03:18 pm January 9, 2020
Respiratory monitor maker NuvoAir (formerly Pond Healthcare Innovation) has picked up its first FDA 510(k) for Air Next, a portable and connected home-use spirometer device. According to the FDA’s premarket notification database, the Stockholm, Sweden-based company submitted its application in November 2018, and received the decision last Thursday. The Air Next is designed for patients with...
By Dave Muoio 04:23 pm October 1, 2019
Edinburgh, Scotland-based patient monitoring wearable and platform company Current Health (formerly snap40) has cut deals with fellow connected monitor maker VivaLNK and spirometry device company MIR (Medical International Research) to add axillary temperature and spirometry measurement capabilities to its offering. Enabled by a 510(k) clearance posted by the FDA back in July, these types of...
By Dave Muoio 09:44 am September 12, 2019
Israeli smartphone urinalysis startup Healthy.io has closed a $60 million Series C funding round led by Corner Ventures, the company announced this morning. Joy Capital Ventures and prior backers Ansonia Holdings, Aleph and Samsung NEXT each participated as well. Furthermore, the company also announced that it has received a second FDA 510(k) clearance intended to support diagnosis of chronic...
By Dave Muoio 11:45 am August 29, 2019
Tel Aviv, Israel-based Biobeat has been granted 510(k) clearance for a remote monitoring device capable of measuring the wearer’s blood pressure, oxygenation and heart rate. Designed for use in the hospital or at home, the device is available as either a wristwatch or adhesive patch. Of particular note, the products differentiate themselves from other remote monitoring devices through a...
By Dave Muoio 03:11 pm July 30, 2019
PhysIQ has received 510(k) clearance for an algorithm facilitating cloud-based analysis of patients’ continuous ambulatory respiration rates, according to an update to the FDA’s device clearance database that was confirmed by the company to MobiHealthNews. This regulatory clearance is the company’s third, and like its predecessors uses artificial intelligence to characterize raw sensor data as...
By Laura Lovett 03:14 pm July 15, 2019
This morning Teva Pharmaceutical Industries announced that the FDA greenlighted its AirDuo Digihaler, a sensor-enabled inhaler. The product, classified as a maintenance asthma inhaler, has a built-in sensor that sends usage data to a corresponding app on a user's smartphone. This information can also be sent to the user’s provider.  The sensor technology is also able to monitor inspiratory flow...
By Dave Muoio 02:30 pm June 17, 2019
The past week has seen two FDA clearances awarded to Israeli companies building artificial intelligence analysis tools for medical imaging. The first, announced last Tuesday, was Aidoc’s tool for triaging cervical spine fractures. Much like the company’s prior offerings, the new product analyzes images to prioritize high-risk cases for review by a radiologist, and does so within the specialist’s...