Global Edition news

By Dave Muoio December 4, 2018
De Novo rule proposal published for review. The FDA has published a new proposal for revisions to the De Novo regulatory pathway for devices without a predicate. The rule, which is currently available for public comment, aims to provide additional structure, clarity and transparency to the process, and outlines how the agency processes and gauges submitted devices. “Our goal is to make the De...
By Jonah Comstock December 4, 2018
There’s an old saying: A journey of 1,000 miles begins with a single step. And for the long journey of digital hospital transformation, that step is creating a robust, accurate, usable provider directory. That’s the thesis of Sara Vaezy, chief digital strategy officer for Providence St. Joseph Health. Vaezy will take the stage at HIMSS19 with Travis Moore, VP of sales at Kyruus, Providence’s...
By Dave Muoio December 4, 2018
Pillo, the countertop device that uses conversational artificial intelligence to help patients manage their treatments, is now available to consumers for online purchase, manufacturer Pillo Health announced this morning. The device is currently being sold for $499 alongside a one-year subscription to the company’s connected service. Designed for older patients or those with chronic diseases and...
By Dave Muoio December 4, 2018
Oulu, Finland-based Oura Health, maker of a sleep- and activity-tracking smart ring, today announced that it has surpassed $20 million in total funding. Based on its previous announcements, this would mean that the company has raised roughly $6.5 million or more in new funding since its most recent round in July. While the latest round was led by MSD Capital, it also featured YouTube cofounder...
By Laura Lovett December 3, 2018
This morning, Lumeon, a digital health startup that employs automation to help with operational functions, announced that it raised $28 million in funding. The investment was led by LSP, with support from MTIP, Gilde, Amadeus Capital Partners and IPF Partners.  The company has developed what it calls a “care pathway management system,” which builds on EHRs and aims to lower healthcare costs by...
By Laura Lovett December 3, 2018
Last week MedPilot, a patient financial engagement platform, scored $1.7 million in seed funding. The latest financing round was led by Hudson River Capital Partners, Valley Growth Ventures, Cedars-Sinai Medical Center, Techstars, and investor Tom Hirscheld.  The company said the new money will help MedPilot expand its workforce and launch new functionality to help providers engage with patients...
By Jonah Comstock December 3, 2018
The FDA has announced the winners of the opioid addiction innovation challenge the agency launched last May. Out of more than 250 applications from medical device developers, the FDA selected eight winners.  "While these products will not automatically receive marketing authorization from the FDA, the device developers will receive increased interaction with CDRH experts, guidance for clinical...
By Laura Lovett December 3, 2018
This morning Tabula Rasa Healthcare, a digital health company focused on medication safety, announced that it has agreed to acquire Australian company DoseMe for an undisclosed sum.  The acquisition, which is set to close the first quarter of 2019, means Tabula Rasa will be acquiring DoseMeRx, a platform designed to help clinicians and pharmacists figure out the proper dose of medication for high...

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