Pharma

By  Dave Muoio 03:43 pm May 4, 2020
Following numerous reports of underperforming COVID-19 antibody tests, the FDA has raised the bar for these products in a revision to its emergency testing policy. As of today, commercial manufacturers that notify the agency of their intent to submit a test for Emergency Use Authorization are required to do so within 10 business days from the date of notification. Further, the FDA has recommended...
By  Dave Muoio 06:00 am April 22, 2020
Less than a week after FDA opened the faucet for digital health products treating psychiatric conditions during the COVID-19 health crisis, Akili has fast-tracked and released its approval-pending digital therapeutic for children with ADHD. Now known as Endeavor and flanked by a symptom tracker and caretaker support line, the video game-like app will be provided at no cost for a limited time to...
By  Dave Muoio 03:12 pm April 20, 2020
International pharma giant Novartis announced this morning the acquisition of Amblyotech, a startup that combines 3D glasses and video game software to treat amblyopia, more commonly known as "lazy eye." The terms of the deal were not disclosed. Novartis also said that it will be developing new games and kicking off a proof-of-concept study alongside major French video game publisher Ubisoft and...
By  Sophie Porter 02:14 am April 18, 2020
Boots, the UK’s largest pharmacy-led health and beauty company, has announced the new stage in the digitisation of its pharmacy service with digital healthcare provider LIVI. The partnership will trial a new online video-consultation platform that connects GPs and Boots’ pharmacists, enabling professionals to provide advice to patients in a safe way through the LIVI app. WHY IT MATTERS Patients...
By  Laura Lovett 04:12 pm April 14, 2020
A new public health tool dubbed World Without COVID launched this morning with the goal of connecting patients to coronavirus clinical trials across the country. The new product, which is powered by digital clinical trial company Clara Health, is aimed at helping propel clinical research and treatment surrounding the virus.  In part, the product was inspired by product cofounder and Lyft Chief...
By  Dave Muoio 03:11 pm April 7, 2020
Connected digital products have steadily become more prominent among clinical research efforts since the start of the millennium, according to new data published Friday in NPJ Digital Medicine. In reviewing every trial registered with ClinicalTrials.gov between the years 2000 and 2017, a group of Harvard researchers found the use of these tools increasing with a compound annual growth rate (CAGR...
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By  PsychU 03:02 pm April 7, 2020
A group of organizations—Amazon, Apple, and Google among others—are blurring the line between the tech field and the healthcare field. One of the key elements in this blurring of the line is the automation of health and human service functions that previously required human work. This tech-enabled automation is frequently accomplished through bots, which are computer applications that perform...
By  Laura Lovett 02:25 pm April 3, 2020
Earlier this week Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections.  Before this test, the products on the market were designed to detect or diagnose if someone currently has the virus. ...
By  Tammy Lovell 08:08 am April 1, 2020
Nordic startup SideKickHealth is working with the COVID-19 response team in Iceland to provide its digital therapeutics platform to people who have been diagnosed with the virus. Its platform allows the remote triaging and managing of large numbers of people in isolation, who self-report on a panel of symptoms and measurements via a smartphone app multiple times a day.  Patients are assessed via...