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...
Livongo’s DPP recogized by the CDC. Digital chronic care company Livongo Health’s Diabetes Prevention Program has received full recognition from the CDC, according to a release from the company. The designation implies that the digital offering meets the agency’s standards as a Type 2 diabetes prevention and lifestyle change intervention, and is listed within the CDC’s online referral tool.
“CDC...
Point-and-shoot wound imaging. Earlier this week, mobile imaging and AI platform Tissue Analytics has revealed a new feature that can generate a 3D image of a patient's wound from a five-second smartphone video. Once made, these images can be easily shared to EMRs through the platform’s integration Cerner, Epic, athenahealth, and Allscripts.
"Tissue Analytics uses sophisticated algorithms that...
A peak at Withings' next device? Rumor has it Withings is creating a new fitness tracker at a lower price point. Wearable reports that a tracker listed by the company as Pulse HR in a recent FCC filing, which could indicate that it will have a heart rate monitor.
For the last two year Withings has been part of Nokia’s digital health division. But the department faced challenges from the get go...
Google Street Breathe? San Francisco-based startup Aclima has announced plans to outfit Google’s fleet of camera-sporting Street View vehicles with mobile air quality and climate emissions sensors. According to the company, all of the data collected using the new system will be aggregated and made available as a public dataset on Google BigQuery. The companies are planning an initial rollout of...
Bankrupting docs? Patient booking platform Zocdoc is putting providers in a sticky situation, CNBC reports. The platform, which lets patients book and cancel appointments, is changing its business model. Now instead of charging providers a flat annual rate per doctor, it proposes to charge a lower annual rate as well as a booking fee for each new customer.
Not only would this dramatically...
Call9 launches data analytics plaform for nursing homes. Nursing home care technology company Call9 has launched a data analytics platform for nursing home administrators and operators. Dubbed SNF Assist, the platform integrates with a facility’s EHR to deliver insights that will help inform users’ operational and medical decisions.
“When we founded Call9 the idea was to be with patients at the...
Wearables do well for Apple. Apple posted strong numbers in its most recent quarterly financial report. Of the $53.3 billion it generated in quarterly revenue (a 17 percent increase over last year), more than half came from international sales. Of note, the company’s wearable revenue — which includes the Apple Watch as well as AirPods and Beats headphones — has brought in more than $10 billion in...
Putting yourself in someone else's shoes. High school students are learning about living with Alzheimer's disease in a new VR experience that simulates the experience for teens. The program, which was presented at the Alzheimer’s Association International Conference yesterday, has multiple different storylines for students to explore. The experience lets students see what it is like to live with...
Sophia Genetics acquires CDS software company. Genomics AI company Sophia Genetics has acquired Interactive Biosoftware, a maker of Alamut, a clinical decision support software for clinical genomic data interpretation. The terms of the deal were not disclosed.
"We are very excited about the acquisition of Interactive Biosoftware," Jurgi Camblong, CEO and cofounder at Sophia Genetics, said in a...
