Blog
RSS FeedPosted by Michael Wonder on 19 Dec 2021
Fist Assist Devices receives FDA “breakthrough device” designation for the world’s first wearable vein dilation device for ESRD patients
16 December 2021 - Indication for pre-surgical vein dilation use to promote AV fistula creation. ...
Posted by Michael Wonder on 14 Dec 2021
FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care
10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...
Posted 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 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 04 Dec 2021
Reforms needed for FDA’s regulation of medical devices
3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex ...
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 25 Nov 2021
A divisive ruling on devices — Genus Medical Technologies v. FDA
24 November 2021 - The FDA has long taken the legal position that regulated devices could also be categorised as drugs. ...
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
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 10 Nov 2021
Ellume's COVID-19 home test recall most serious, FDA says
10 November 2021 - The U.S. FDA classified the recall of Ellume's over-the-counter COVID-19 home test as Class 1, the ...