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...
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...
This week in M&A. Imprivata, a tech company providing identity and authentication tools designed specifically for healthcare, has acquired GroundControl Solutions, inc., which is known for its automated enterprise mobile device management software. Imprivata anticipates that the purchase of this new tech will augment its platform with new capabilities for large and small healthcare...
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...
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...
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...
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 “...
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...
ECG algorithm picks up Breakthrough Device status. Eko, the maker of tools for monitoring heart function, announced yesterday that a novel ECG-based algorithm for detecting lowered left ventricular ejection fraction has received Breakthrough Device designation from the FDA. By analyzing a 15-second clip of ECG data collected via the company’s other products, the algorithm aims to assist with...
The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system.
Tandem Diabetes Care’s Control-IQ Technology acts as a new feature for the company’s t:slim X2 insulin pump (which was also cleared by the FDA back in February). The controller algorithm allows the pump and its connected system to...
