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RSS FeedPosted 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 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 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 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 ...
Posted by Michael Wonder on 09 Feb 2023
CoolHealth enters US market with TargetCool, a breakthrough FDA class II medical device offering unprecedented precise, rapid cooling for pain management and bruise minimisation
8 February 2023 - CoolHealth is entering the US market with a breakthrough FDA Class II medical device, TargetCool. ...
Posted by Michael Wonder on 23 Jan 2023
RenalGuard Therapy receives FDA breakthrough device designation for prevention of cardiac surgery associated AKI
20 January 2023 - CardioRenal Systems announced today that the FDA granted breakthrough device designation for its RenalGuard Therapy device ...
Posted by Michael Wonder on 19 Jan 2023
Abbott receives FDA approval for Navitor, a next generation TAVI system designed to treat aortic stenosis
17 January 2023 - Abbott's new Navitor device features advancements to improve patient care, including reducing or eliminating risk of blood ...
Posted by Michael Wonder on 12 Jan 2023
Medcura receives breakthrough device designation for its LifeGel absorbable surgical hemostat
13 January 2023 - Medcura announces that the US FDA has granted the coveted breakthrough device designation for its LifeGel absorbable ...
Posted by Michael Wonder on 11 Jan 2023
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection
10 January 2023 - The OncobiotaLUNG assay is the first blood microbiome driven liquid biopsy with proven effectiveness, including identifying cancer ...
Posted by Michael Wonder on 11 Jan 2023
EndoTheia announces FDA breakthrough device designation for technology to improve endoscopic surgery
10 January 2023 - EndoTheia announced today that it has gained priority status from the FDA by receiving a breakthrough ...