Blog
RSS FeedPosted by Michael Wonder on 14 Sep 2017
FDA permits marketing of mobile medical application for substance use disorder
14 September 2017 - Today, the U.S. FDA permitted marketing of the first mobile medical application to help treat substance use ...
Posted by Michael Wonder on 12 Sep 2017
Streamlined FDA reviews fail to catch dangerous glitches in health software, study finds
12 September 2017 - The FDA carefully polices many categories of drugs and devices. ...
Posted by Michael Wonder on 05 Sep 2017
Interoperability: FDA’s final guidance on smart, safe, medical device interactions
5 September 2017 - Imagine an intensive care unit for newborns. An interface on a device called a pulse oximeter is ...
Posted by Michael Wonder on 25 Jul 2017
Practical improvements for medical device evaluation
25 July 2017 - Passage of the Medical Device Amendments Act in 1976 confirmed the US FDA’s primary responsibility for evaluating ...
Posted by Michael Wonder on 20 Jul 2017
FDA clears first neonatal magnetic resonance imaging device
20 July 2017 - Today, the U.S. FDA cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain ...
Posted by Michael Wonder on 03 Jul 2017
FDA clears expanded use of cooling cap to reduce hair loss during chemotherapy
3 July 2017 - Today, the U.S. FDA cleared the expanded use of a cooling cap, DigniCap Cooling System, to ...
Posted by Michael Wonder on 29 Jun 2017
FDA allows marketing of test to aid in the detection of certain leukemias and lymphomas
29 June 2017 - The U.S. FDA today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first ...
Posted by Michael Wonder on 15 Jun 2017
Fostering medical innovation: a plan for digital health devices
15 June 2017 - It is incumbent upon FDA to ensure that we have the right policies in place to promote ...
Posted by Michael Wonder on 14 Jun 2017
How creative FDA regulation led to first-in-the-world approval of a cutting edge heart valve
14 June 2017 - Nearly six years ago FDA approved an artificial transcatheter heart valve to treat patients having severe ...
Posted by Michael Wonder on 06 Jun 2017
Bayer receives FDA approval of myBETAapp and BETACONNECT Navigator
30 May 2017 - Now-approved combination of medicine, device, mobile and cloud-based health technology. ...
Posted by Michael Wonder on 05 Jun 2017
FDA expands use of Sapien 3 artificial heart valve for high-risk patients
5 June 2017 - Expanded use approval relies on real world evidence. ...
Posted by Michael Wonder on 02 Jun 2017
Roche announces FDA approval of companion diagnostic to identify ALK positive non-small-cell lung cancer patients
1 June 2017 - The Ventana ALK CDx assay identifies ALK positive non-small-cell lung cancer patients eligible for treatment with the ...
Posted by Michael Wonder on 13 May 2017
FDA authorises use of new device to treat oesophageal birth defect in babies
12 May 2017 - The U.S. FDA today authorised use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device ...
Posted by Michael Wonder on 03 May 2017
Roche receives FDA approval for complementary PD-L1 (SP263) biomarker test in urothelial carcinoma
2 May 2017 - Use of the VENTANA PD-L1 (SP263) assay to determine PD-L1 expression in urothelial carcinoma may help to ...
Posted by Michael Wonder on 06 Apr 2017
FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions
6 April 2017 - The U.S. FDA today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk tests for ...