Blog
RSS FeedPosted by Michael Wonder on 13 Dec 2021
InterVene’s BlueLeaf Endovenous Valve Formation System granted breakthrough device designation by the FDA
13 December 2021 - InterVene announced today that it has received breakthrough device designation by the FDA for the company’s BlueLeaf ...
Posted by Michael Wonder on 10 Dec 2021
Cytokinetics announces receipt of breakthrough therapy designation from FDA for aficamten
9 December 2021 - FDA granted designation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy Based on results of REDWOOD-HCM. ...
Posted by Michael Wonder on 07 Dec 2021
Linus Biotechnology receives FDA breakthrough device designation for StrandDx-ASD exposome sequencing diagnostic
7 December 2021 - Linus Biotechnology today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health ...
Posted by Michael Wonder on 05 Dec 2021
RefleXion receives breakthrough device designation for lung cancer treatment
1 December 2021 - RefleXion Medical today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 03 Dec 2021
ZetaMet receives breakthrough device designation from U.S. FDA for treatment of metastatic bone cancers
1 December 2021 - The technology is a first of its kind molecular pathway designed to suspend cancer, inhibit pain, and ...
Posted by Michael Wonder on 01 Dec 2021
Silverlon receives FDA breakthrough device designation for radiation dermatitis and cutaneous radiation injury
30 November 2021 - Innovative Silverlon silver plated nylon dressing contains more metallic silver than any other dressing; anti-microbial properties of ...
Posted by Michael Wonder on 30 Nov 2021
AMF Medical receives FDA breakthrough device designation for its Sigi insulin management system
30 November 2021 - Sigi is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled ...
Posted by Michael Wonder on 26 Nov 2021
Blackrock Neurotech's MoveAgain brain computer interface system receives breakthrough device designation from the FDA
16 November 2021 - Blackrock Neurotech today announces that the U.S. FDA has granted breakthrough device designation for its groundbreaking ...
Posted by Michael Wonder on 24 Nov 2021
HAGAR GWave awarded FDA breakthrough device designation
23 November 2021 - Expediting development of GWave technology that may potentially improve the health and quality of life for millions ...
Posted by Michael Wonder on 22 Nov 2021
Pear Therapeutics receives FDA breakthrough device designation for prescription digital therapeutic candidate to treat alcohol use disorder
22 November 2021 – Pear Therapeutics today announced that it has received breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 22 Nov 2021
FDA grants breakthrough designation for early stage breast cancer detection blood test developed by Datar Cancer Genetics
19 November 2021 - TriNetra is a circulating tumour cell detection blood test which is able to identify early stage ...
Posted by Michael Wonder on 20 Nov 2021
FDA grants Theradaptive breakthrough medical device designation
19 November 2021 - Theradaptive announced that the U.S. FDA has granted breakthrough medical device designation to its Osteo-Adapt SP Spinal ...
Posted by Michael Wonder on 13 Nov 2021
CMS repeals MCIT/R&N rule; will consider other coverage pathways to enhance access to innovative medical devices
12 November 2021 - Today, CMS is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) ...
Posted by Michael Wonder on 08 Nov 2021
Man & Science announces U.S. FDA breakthrough device designation granted for the treatment of chronic cluster headache
8 November 2021 - Man & Science announced today that it has been granted a breakthrough device designation by the Center ...
Posted by Michael Wonder on 05 Nov 2021
FDA awards breakthrough device designation to the ReWalk ReBoot Soft Exo-Suit
4 November 2021 - Soft exoskeleton device for stroke survivors will be for use at home and in the community ...