Blog
RSS FeedPosted by Michael Wonder on 02 Nov 2018
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery
2 November 2018 - Today, the U.S. FDA permitted marketing of two devices that provide real-time location of parathyroid tissue during ...
Posted by Michael Wonder on 01 Nov 2018
Director of the FDA’s Center for Devices and Radiological Health and Director of the FDA’s Center for Drug Evaluation and Research on agency’s warning to consumers about genetic tests that claim to predict patients’ responses to specific medications
1 November 2018 - As a public health agency, one of our key roles is to promote and advance safe ...
Posted by Michael Wonder on 31 Oct 2018
FDA authorises first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism
31 October 2018 - Today, the U.S. FDA permitted marketing, with special controls, of the 23andme Personal Genome Service Pharmacogenetic Reports ...
Posted by Michael Wonder on 25 Oct 2018
FDA permits marketing of a diagnostic test to aid in the determination of menopausal status
24 October 2018 - Today, the U.S. FDA permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the ...
Posted by Michael Wonder on 17 Oct 2018
FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety
16 October 2018 - As part of the Administration’s ongoing efforts to strengthen cybersecurity in health care, the U.S. FDA ...
Posted by Michael Wonder on 11 Oct 2018
FDA approves new DNA-based test to determine blood compatibility
11 October 2018 - Test is first approved to report genotypes as final results. ...
Posted by Michael Wonder on 08 Oct 2018
FDA allows marketing of first self-fitting hearing aid controlled by the user
5 October 2018 - The U.S. FDA today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify ...
Posted by Michael Wonder on 01 Oct 2018
Statement from FDA Commissioner on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients
1 October 2018 - The threat of cyber attacks is no longer theoretical. Cyber criminals and adversaries can inflict significant ...
Posted by Michael Wonder on 28 Sep 2018
FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukaemia or multiple myeloma
28 September 2018 - Today the U.S. FDA permitted marketing of ClonoSEQ assay, a next generation sequencing-based test for minimal residual ...
Posted by Michael Wonder on 17 Sep 2018
FDA approves device for treatment of acute coronary artery perforations
17 September 2018 - The U.S. FDA today approved a device intended to treat acute coronary artery perforations, or tears in ...
Posted by Michael Wonder on 14 Sep 2018
FDA approves device for treatment of acute coronary artery perforation
14 September 2018 - The U.S. FDA today approved a device intended to treat acute coronary artery perforations, or tears in ...
Posted by Michael Wonder on 12 Sep 2018
FDA awards five grants to advance the development of paediatric medical devices
12 September 2018 - The U.S. FDA announced today that it has awarded five grants totalling up to $6 million per ...
Posted by Michael Wonder on 05 Sep 2018
New program with payers aims to accelerate patient access to medical devices
5 September 2018 - Advancing the public health means helping to make sure patients have access to safe, effective medical products. ...
Posted by Michael Wonder on 02 Jul 2018
Dermira receives FDA approval for Qbrexza (glycopyrronium) cloth to treat primary axillary hyperhidrosis
29 June 2018 - Qbrexza is expected to be available for prescribing in October 2018. ...
Posted by Michael Wonder on 30 May 2018
As part of efforts to combat opioid crisis, FDA launches innovation challenge to spur development of medical devices ‒ including digital health and diagnostics ‒ that target pain, addiction and diversion
30 May 2018 - Agency will work closely with selected applicants to accelerate product development. ...