Blog
RSS FeedPosted by Michael Wonder on 05 Mar 2020
Allergan receives FDA approval for Durysta (bimatoprost implant) the first and only intracameral biodegradable sustained-release implant to lower intra-ocular pressure in open-angle glaucoma or ocular hypertension patients
5 March 2020 - Durysta lowered intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension by approximately 30% from baseline ...
Posted by Michael Wonder on 26 Feb 2020
FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
26 February 2020 - Today, the U.S. FDA is announcing the voluntary electronic Submission Template And Resource (eSTAR) Pilot Program as ...
Posted by Michael Wonder on 10 Dec 2019
FDA approves etectRx ‘digital pill’ as rivals struggle
10 December 2019 - The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as ...
Posted by Michael Wonder on 24 Nov 2019
Lifecycle regulation of artificial intelligence and machine learning–based software devices in medicine
22 November 2019 - Artificial intelligence and machine learning (AI/ML) based technologies aim to improve patient care by uncovering new ...
Posted by Michael Wonder on 23 Sep 2019
Statement on FDA efforts to encourage patient engagement in medical device clinical investigations
23 September 2019 - At the U.S. FDA we are committed to keeping patients, their families and caregivers at the center ...
Posted by Michael Wonder on 19 Sep 2019
FDA continues to take steps to fulfil its commitment to strengthen and modernise the 510(k) medical device program
19 September 2019 - The U.S. FDA today announced that, as a first step toward implementation of the recently established Safety ...
Posted by Michael Wonder on 18 Sep 2019
FDA continues steps to promote innovation in medical devices that help advance patient safety through the Safer Technologies Program
18 September 2019 - Today, the Food and Drug Administration issued draft guidance titled “Safer Technologies Program for Medical Devices,” ...
Posted by Michael Wonder on 05 Sep 2019
FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need
5 September 2019 - Today, the U.S. FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated ...
Posted by Michael Wonder on 30 Jul 2019
Moving from substantial equivalence to substantial improvement for 510(k) ddevevices
29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. ...
Posted by Michael Wonder on 25 Jul 2019
Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia
25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...
Posted by Michael Wonder on 14 Jul 2019
How the FDA uses science to speed medical device innovation
11 July 2019 - The MDDT program streamlines the medical device development and review process. ...
Posted by Michael Wonder on 23 Jun 2019
Statement on agency’s efforts to increase transparency in medical device reporting
21 June 2019 - In the spirit of promoting public transparency, the U.S. Food and Drug Administration’s Center for Devices ...
Posted by Michael Wonder on 08 Jun 2019
FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age
7 June 2019 - The U.S. FDA today permitted marketing of the first medical device to aid in the reduction ...
Posted by Michael Wonder on 23 May 2019
FDA permits marketing of first diagnostic test to aid in detecting prosthetic joint infections
23 May 2019 - Today, the U.S. FDA permitted marketing of the Synovasure Lateral Flow Test Kit as an aid for ...
Posted by Michael Wonder on 02 May 2019
FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices
2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...