Blog
RSS FeedPosted by Michael Wonder on 03 Apr 2023
FDA draft guidance allows AI/ML devices to evolve without requiring new submissions
31 March 2023 - The US FDA published a draft guidance outlining how sponsors of artificial intelligence and machine learning (AI/ML) ...
Posted by Michael Wonder on 02 Apr 2023
Pixium Vision announces FDA breakthrough device designation for the Prima System in dry AMD
31 March 2023 - PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around ...
Posted by Michael Wonder on 29 Mar 2023
FDA grants breakthrough device designation to Aural Analytics for speech analytics software to be used in treatment of ALS
29 March 2023 - Aural Analytics today announced that its Speech Vitals - ALS technology has been granted designation as ...
Posted by Michael Wonder on 29 Mar 2023
Medical device companies now need to prove to FDA they’re protected against cyber attacks
29 March 2023 - Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and ...
Posted by Michael Wonder on 09 Mar 2023
Mallinckrodt announces reimbursement approval in Japan for the Celllex extracorporeal photopheresis system for the treatment of chronic graft versus host disease
9 March 2023 - Cellex ECP is now available for reimbursement in Japan for patients who are steroid-resistant or intolerant ...
Posted by Michael Wonder on 08 Mar 2023
The unique device identifier: a unique opportunity
7 March 2023 - A unique device identifier is an individualised alphanumeric signature associated with a single medical device. Since 2013, ...
Posted by Michael Wonder on 07 Mar 2023
FDA grants Lenire tinnitus treatment device de novo approval
7 March 2023 - FDA approval based on results of 112 patient pivotal TENT-A3 clinical trial supported by confirmatory real world ...
Posted by Michael Wonder on 06 Mar 2023
Sooma Medical receives FDA breakthrough device designation for its innovative at home depression treatment device
6 March 2023 - Sooma Medical has been granted breakthrough device designation by the US FDA for its portable, patient-administered ...
Posted by Michael Wonder on 05 Mar 2023
Medicine and medical device pricing and reimbursement in Netherlands
2 March 2023 - Since the Netherlands is a Member State of the European Union, it has implemented the European ...
Posted by Michael Wonder on 02 Mar 2023
Boomerang Medical earns FDA breakthrough device designation
1 March 2023 - Boomerang Medical is currently enrolling a clinical trial studying a bioelectronic device for people living with Crohn’s ...
Posted by Michael Wonder on 27 Feb 2023
EMA pilots scientific advice for certain high risk medical devices
27 February 2023 - The EMA has launched a pilot to give scientific advice on the intended clinical development strategy ...
Posted by Michael Wonder on 23 Feb 2023
ONWARD receives new FDA breakthrough device designations for bladder control, alleviation of spasticity and blood pressure regulation after spinal cord injury
23 February 2023 - The company has now been awarded a total of eight FDA breakthrough device designations for its innovative ...
Posted by Michael Wonder on 21 Feb 2023
PHARMAC signals first step towards funding continuous glucose monitors
21 February 2023 - PHARMAC will soon be seeking competitive commercial offers for the supply of funded continuous glucose monitors ...
Posted by Michael Wonder on 16 Feb 2023
Zephyrus Innovations announces US FDA approval for its Aeroject 3 mL safety syringe
16 February 2023 - Aeroject has a permanently attached needle system, which upon retraction, fully encases the needle, preventing needle reuse ...
Posted by Michael Wonder on 16 Feb 2023
Merit Medical receives FDA breakthrough device designation for the new SCOUT MD surgical guidance system
16 February 2023 - Next generation system helps improve surgical precision to enhance patient care in breast and other soft tissue ...