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By Dave Muoio January 11, 2019
CES 2019 is in its waning days, and with its end comes a time for reflection. This year’s consumer tech expo boasted no shortage of health and wellness products on display, ranging from novel ECG-equipped wearables to novel approaches to skin care. Meanwhile, the Digital Health Summit — CES’ sub-event focused exclusively on health technology — celebrated its tenth year at the show with two full...
By Jonah Comstock January 11, 2019
The Embrace2, a seizure monitoring wearable from Boston and Milan-based Embrace, has received an updated FDA clearance that allows it to be used by children ages six and up — the first such device to receive clearance for pediatric use. "The fact that this is the first clearance of its kind in epilepsy highlights how difficult it is to get robust results with pediatric patients in a clinical...
By Dave Muoio January 11, 2019
Once a health tech industry darling, Chicago-based unicorn Outcome Health has lately found itself on hard times. Since the publication of a Wall Street Journal investigation alleging the point of care digital advertiser had misled its clients by providing inaccurate and manipulated performance data, Outcome has faced a lawsuit from its biggest investors, severed deals with major hospitals, and...

A screengrab of an animated simulation of how AWAK's peritoneal dialysis device works. Credit: AWAK

By Dean Koh January 11, 2019
Earlier this week, AWAK Technologies (AWAK), a Singapore-headquartered medical technology company focused on dialysis using regeneration technology for end-stage renal disease, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and ultra-portable PD system that incorporates AWAK’s...

Photo: Dr. James Creeden, Global Medical Director of Foundation Medicine​. Credit: Foundation Medicine.

By Dean Koh January 10, 2019
Launched in 2010 with a $25 million Series A financing led by Third Rock Ventures, Foundation Medicine released its first commercial assay called FoundationOne in 2012. The company develops, manufactures, and sells genomic profiling assays based on next-generation sequencing technology for solid tumours, hematologic malignancies, and sarcomas. In December 2017, the company’s assay FoundationOne...

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