FDA

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 01:40 pm December 19, 2019
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...
By Dave Muoio 02:13 pm December 16, 2019
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...
By Dave Muoio 04:03 pm December 9, 2019
Gainesville, Florida-based etectRx has received FDA 510(k) clearance for its ID-Cap System, a prescription ingestible system that sends adherence event logs to an external medical device. Similar to the system pioneered by etectRx’s high-profile competitor, Proteus Digital Health, the ID-Cap’s core is a standard capsule containing a sensor that transmits a message once it comes into contact with...
By Dave Muoio 03:56 pm December 5, 2019
#Pelotonad. Peloton has found itself in the middle of controversy as a recent television ad released by the company was panned by many as sexist. The roughly 30-second video, in which a husband purchases the connected exercise bike for his wife as a Christmas gift, has generated a backlash consisting of Twitter hashtags, viral parodies and a roughly 10% drop in Peloton’s stock price; however, the...
By Dave Muoio 03:00 pm December 5, 2019
The FDA and National Institutes of Health are tapping the clinical community and a newly launched mobile platform in its search for novel infectious disease interventions. Called CURE ID, the online data repository will allow clinicians to report instances in which existing FDA-approved drugs are used to successfully treat infections. In particular, the tool captures clinical outcomes in cases...
By Dave Muoio 04:37 pm December 4, 2019
Dr. John Halamka, a longtime CIO, executive director and professor tied to Harvard-affiliated Beth Israel Deaconness Medical Center, will be joining the Mayo Clinic on January 1 as the new president of its Mayo Clinic Platform — a digital health project that will deploy “artificial intelligence, the internet of things and an ecosystem of partners,” he wrote in a blog post announcing the move....
By Dave Muoio 04:07 pm November 19, 2019
Device regulation is a hurdle for any medical tech company, but doubly so for startups hoping to strike it big with their very first digital health product. With limited resources and experience, pushing a device through the FDA’s door and onto the market is a multi-year gauntlet of validation, documentation and, unfortunately, frustration. To help young companies take a bit of the guesswork out...

The 510 (K) clearance, pre-market submission, will enable the business to make EchoGo available to clinicians and healthcare providers in the US.

By Tammy Lovell 02:08 am November 18, 2019
UK-based health technology firm Ultromics has received clearance from the US Food and Drug Administration (FDA) for its cardiovascular image analysis system, EchoGo Core. EchoGo applies artificial intelligence (AI) to automate the analysis and quantification of ultrasound-based heart scans. The 510 (K) clearance, pre-market submission, will enable the business to make EchoGo available to...