Blog
RSS FeedPosted 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 19 Mar 2023
Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18
14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...
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 23 Feb 2023
Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection
22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...
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
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 30 Jan 2023
Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate
30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated ...
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 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
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 ...
Posted by Michael Wonder on 09 Jan 2023
Opticyte earns FDA breakthrough device designation for the first cell O2 patient monitor for organ failure
9 January 2023 - Opticyte leverages proprietary machine learning to non-invasively assess organ dysfunction due to low cellular oxygenation in ...