Blog
RSS FeedPosted by Michael Wonder on 12 May 2021
DermaSensor granted FDA breakthrough device designation
11 May 2021 - FDA designation fast tracks getting cancer detection device in the hands of healthcare professionals ...
Posted by Michael Wonder on 11 May 2021
Avenda Health granted FDA breakthrough device designation for technology to treat prostate cancer
11 May 2021 - Avenda Health advances male “lumpectomy” for prostate cancer with new in office, AI based focal therapy system. ...
Posted by Michael Wonder on 04 May 2021
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
4 May 2021 - Breakthrough designation helps advance treatment options, targeting a significant unmet need in the treatment of critical limb-threatening ischaemia. ...
Posted by Michael Wonder on 30 Apr 2021
Cerapedics announces FDA breakthrough device designation granted for P-15L bone graft for the treatment of degenerative disc disease
29 April 2021 - P-15L bone graft is currently being studied in the Company's ASPIRE IDE clinical trial. ...
Posted by Michael Wonder on 28 Apr 2021
EYEMATE system for remote glaucoma management obtains FDA breakthrough device designation
28 April 2021 - - Implandata Ophthalmic Products has announced today that its game-changing EYEMATE system for digitally enabled remote patient ...
Posted by Michael Wonder on 27 Apr 2021
Medtronic receives FDA breakthrough designation for the Emprint ablation catheter kit
27 April 2021 - Minimally invasive option has potential to provide long-term management of lung malignancies while protecting lung function. ...
Posted by Michael Wonder on 27 Apr 2021
Fractyl announces FDA breakthrough device designation for Revita DMR in insulin treated type 2 diabetes
27 April 2021 - REVITA-T2Di trial is underway to evaluate the effectiveness of Revita DMR in improving glucose control while reducing ...
Posted by Michael Wonder on 23 Apr 2021
FDA authorises marketing of device to facilitate muscle rehabilitation in stroke patients
23 April 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use in patients 18 and ...
Posted by Michael Wonder on 21 Apr 2021
Medtronic receives U.S. FDA approval for pipeline flex embolisation device with shield technology
21 April 2021 - First patient receives new shield surface modification, an advance in flow diversion therapy, at NYU Langone Health. ...
Posted by Michael Wonder on 19 Apr 2021
FDA issues final rule removing certain software from medical device regulations
19 April 2021 - The US FDA has issued a final rule making that eliminates certain software intended to transfer, ...
Posted by Michael Wonder on 15 Apr 2021
Perimeter Medical Imaging AI receives U.S. FDA breakthrough device designation for its optical coherence tomography imaging system with ImgAssist AI
15 April 2021 - New designation provides potential pathway to expedite adoption of Perimeter's transformative medical imaging technology combined with artificial ...
Posted by Michael Wonder on 09 Apr 2021
FDA authorises marketing of first device that uses artificial intelligence to help detect potential signs of colon cancer
9 April 2021 - Medical device aids clinicians in detecting potential irregularities during colon cancer screening and surveillance. ...
Posted by Michael Wonder on 07 Apr 2021
IceCure Medical granted FDA breakthrough device designation for Prosense cryoablation system
5 April 2021 - IceCure Medical announced today that it has been granted designation as a breakthrough device from the ...
Posted by Michael Wonder on 31 Mar 2021
Premia Spine announces FDA breakthrough device designation for its TOPS spinal arthroplasty system
31 March 2021 - First-of-a-kind system designed to offer new treatment option for patients with spinal stenosis and spondylolisthesis. ...
Posted by Michael Wonder on 31 Mar 2021
Bluestar Genomics receives FDA breakthrough device designation for first-of-its-kind pancreatic cancer screening test
31 March 2021 - Company accelerates commercialisation efforts to address a million at-risk patients’ unmet needs. ...