FDA 510(k)

A product image of the existing AncestryHealth offering.

By Dave Muoio 03:15 pm August 24, 2020
Consumer genomics company Ancestry recently received two FDA 510(k)s – one for an in vitro molecular test that detects genomic variants tied to potential disease risk, and another for a saliva-based DNA specimen-collection kit. Both of these submissions were received by the FDA in October of last year, which officially cleared them on August 13, according to the agency's 510(k) database. Each was...
By Dave Muoio 03:03 pm August 18, 2020
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing. WHAT HAPPENED This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...
By Dave Muoio 11:08 am June 26, 2020
London-based startup Circadia Health announced Thursday that it has received an FDA 510(k) clearance for its C100 System, a bedside device to measure respiration rate via radar in adult patients up to four feet away. Circadia said in its announcement that the C100 system will be launching "immediately" in light of the high demand for respiratory-related illness management. The startup is aiming...
By Dave Muoio 02:51 pm June 3, 2020
WellDoc's BlueStar chronic disease-management tool has picked up another 510(k) FDA clearance that will allow it to support adult Type 2 diabetes patients using long-acting basal insulin. The feature was announced by WellDoc this morning, but cleared by the agency in April, according to a listing on its website. The new capability takes the form of a new program within the prescription BlueStar...
By Laura Lovett 02:00 pm May 6, 2020
This morning the FDA granted Australian company Headsafe a 510(k) clearance for its connected headgear that is able to perform an assessment of the brain.  Named Nurochek, the system uses Visual Evoked Potential (VEP) in order to gauge brain health. When a user puts on the headgear, which includes a set of goggles, the system presents visual stimulus to the brain. As this process is taking place...
By Dave Muoio 02:38 pm April 16, 2020
The FDA released new guidance on digital health devices for treating psychiatric disorders that waives several regulatory requirements – such as need to submit a 510(k) premarket notification – for the duration of the COVID-19 emergency. "Device availability may increase patient access to digital therapeutics while individuals are following 'stay at home' orders or practicing social distancing,...
By Dave Muoio 04:09 pm April 6, 2020
From me to you. Employee-wellness company Wellable has acquired assets from fellow digital-wellness product-maker MeYou Health, the companies announced. While the terms of the deal were not disclosed, it does transfer ownership of MeYou's Daily Challenge product to Wellable. This program encourages healthy eating, physical activity, stress management and other behaviors through daily email and...
By Dave Muoio 03:53 pm March 26, 2020
Pear Therapeutics announced this morning that Somryst, its prescription digital therapeutic for adults with chronic insomnia, has received marketing authorization from the FDA. The treatment provides cognitive behavioral therapy for insomnia (CBTi) alongside personalized, algorithm-generated sleep restriction recommendations. The digital therapeutic was reviewed through the agency's 510(k)...
By Dave Muoio 03:56 pm March 25, 2020
Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA. The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
By Dave Muoio 01:44 pm February 5, 2020
Into the Great White North. MDClone, a patient data-focused startup, told MobiHealthNews that it will be debuting its platform in Canada thanks to a new partnership with The Ottawa Hospital. With it, the hospital’s practitioners and researchers will have a synthetic set of patient data that, although statistically comparable to the original, includes no identifiable information so that medical...