toSense’s CoVa Monitoring System clears the FDA
The necklace-like device is made for at-home patients with chronic illnesses, such as congestive heart failure (CHF), COPD, hypertension, and renal failure.
Nipro Diagnostics’ TRUE METRIX AIR clears the FDA
The self-monitoring blood glucose system allows diabetics to test blood glucose and deliver data wirelessly to a smartphone.
FDA to simplify the use of foreign clinical trial data for medical device makers
The FDA wants that medical device clinical trials conducted outside of the US are either equal to or greater than US requirements for human protection.
Sense4Baby receives FDA clearance for patient self-administration
Sense4Baby already has FDA's 510(k) clearance for use accompanied by medical professionals, as well as EU's CE mark for self-administration, including the home.
TraumaCad hip replacement mobile app clears the FDA
The application allows professionals and orthopedic surgeons to conduct pre-operative planning of total hip replacement surgery.
Gauss Surgical’s Triton Canister app gets the FDA 510(k) clearance
The system can accurately estimate blood loss in blood bearing canisters, giving clinicians a better picture of overall surgical blood loss.
FDA’s first mHealth app is looking to tackle drug shortages
Available as a free download, the application enables users to quickly identify drug shortages, resolved shortages, and discontinuations of drug products.
23andMe gets FDA’s approval for Bloom Syndrome test
It's not really the same thing as 23andMe's original offering which screened for 254 diseases, but it's an important step in the right direction.
ALR seeking an FDA approval for diabetes feature of its chronic care platform
The tool would draw data from a blood glucose meter, and feed it through an algorithm to provide doctors with guidelines on how much insulin to prescribe.
FDA issues final guidance on mHealth app regulation
The Agency opted for a hands-off approach to most medical device data systems (MDDS), or software that conveys data to and from a medical device.