FDA 510(k)

By Dave Muoio 03:53 pm March 26, 2020
Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA. The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k)...
By Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
By Dave Muoio 01:44 pm February 5, 2020
Into the Great White North. MDClone, a patient data-focused startup, told MobiHealthNews that it will be debuting its platform in Canada thanks to a new partnership with The Ottawa Hospital. With it, the hospital’s practitioners and researchers will have a synthetic set of patient data that, although statistically comparable to the original, includes no identifiable information so that medical...
By Laura Lovett 01:36 pm February 3, 2020
Sony’s smart operating platform NUCLeUS Operating Room scored FDA 510(k) clearance late last week. The new system allows clinicians to capture, store and share OR videos, scans and other patient data throughout its hospital network. This will also allow videos, including 3D videos, to be captured in "near real time.” The latest tool was designed to reduce hardware requirements in the operating...
By Laura Lovett 11:51 am January 28, 2020
This morning digital cardiac health startup Eko announced that its atrial fibrillation and heart murmur detection algorithm landed a 510(k) FDA clearance. The new algorithms are designed to integrate with Eko’s stethoscope, which is already on the market, and be used by healthcare providers.  The company said it plans to add more algorithms in the future. Next up will be an ECG-based algorithm...
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...