FDA Clears First AI X-Ray System
The U.S. Food and Drug Administration has provided clearance to a new artificial intelligence-powered X-ray device developed by GE Healthcare in partnership with UC San Francisco. Named Critical Care Suite, the technology uses AI algorithms to scan X-ray images and detect pnuemothorax, or collapsed lung–a condition that affects about 74,000 within the United States each year. The suite provides for automated AI quality check features which monitors acquisition errors and alerts technologists to make necessary corrections. “The health-care industry is producing huge amounts of data from images to digital health records,” GE Healthcare CEO Kieran Murphy said in an interview with CNBC, “We strongly believe that you have to turn that data into information and insight to improve outcomes.”
Microsoft, Google, & Amazon Compete To Store Health Data
Tech giants, Microsoft, Google, and Amazon are engaged in a fast and growing competition to provide hospitals and health organizations with cloud software to store health data. In July, Providence St. Joseph Health announced a data storage agreement with Microsoft. Shortly after EHR company Cerner Corp, revealed a cloud storage agreement with Amazon Web Services–the companies cloud computing unit. Earlier this week Google announced a 10 year partnership with Mayo Clinic to store the hospitals medical, genetic and financial data. The announcements mark the accelerated move towards cloud storage within major healthcare systems, while highlighting the heightened need for deftly advanced data security.
Smartphone Urinalysis Startup Closes $60 Million Funding Round
Healthy.io, a smartphone urinalysis startup has completed a $60 million Series C funding round led by Corner Ventures, Ansonia Holdings, Aleph and Samsung NEXT. Alongside the successful funding round, the company announced a second FDA 510 (k) clearance to support the diagnosis of chronic kidney diseases. The company’s primary product, Dip.io is a smartphone enabled testing kit with a disposable strip, testing cups, and colored panel. The diagnostic technology generates readings and directly provides users with their results. The new clearance covers an albumin-to-creatinine (ACR) test kit that can detect kidney impairment. Now, the diagnostic tool can be used at any pharmacy, urgent care center, or health clinic within the U.S. In a released statement, Yonatan Adiri, founder and CEO of Healthy.io shared: “The smartphone has the potential to be the great equalizer of healthcare. To unlock this potential, companies must adhere to the highest clinical standards. Our second FDA clearance and additional funding allows us to expand access to critical tests and care beyond our first 100,000 patients in Europe and Israel, making it a reality for millions of Americans suffering from diabetes and hypertension, who are at risk for chronic kidney disease.”
New Privacy Guidelines for Consumer Health Data
The Consumer Technology Association have developed a new set of guidelines for dealing with consumer health data. With members includings organizations such as Doctor on Demand and IMB among others, the association released the “Guiding Principles for the Privacy of Personal Health and Wellness Information” to assist medical technology companies navigate the unique and complex obstacles in handling sensitive patient health data. While the guide provides useful advice on building and maintaining consumer confidence, security guidelines, and existing legal frameworks, the guideline also notes that, as by nature the industry is continually evolving, medical companies would do well to continually remained informed on the latest updates and trends: “Consumer preferences and their comfort with technology will evolve, and a company’s approach to communication should evolve, too. […] Stay informed about changes to and interpretation of privacy laws that apply to you. You can sign up for alerts and mailings from your applicable regulators, outside counsel, and industry groups.”