Blog
RSS FeedPosted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its ...
Posted by Michael Wonder on 13 Jan 2021
Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease
12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...
Posted by Michael Wonder on 23 Dec 2020
Occlutech’s atrial flow regulator receives U.S. FDA breakthrough device designation
18 December 2020 - Occlutech announced today that the US FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 23 Dec 2020
TricValve transcatheter bicaval valves system granted designation as breakthrough device by the U.S. FDA
22 December 2020 - P+F Products + Features has been granted designation as a breakthrough bevice for the company's lead product, ...
Posted by Michael Wonder on 22 Dec 2020
FDA approves prosthetic implant for above the knee amputations
18 December 2020 - The U.S. FDA today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the ...
Posted by Michael Wonder on 16 Dec 2020
FDA authorises marketing of new implant to repair a torn anterior cruciate ligament
16 December 2020 - Today, the U.S. FDA granted marketing authorisation—under the De Novo premarket review pathway—for an anterior cruciate ligament ...
Posted by Michael Wonder on 16 Dec 2020
Spark Biomedical receives FDA breakthrough device designation for infant transcutaneous auricular neurostimulation device, the Roo system
15 December 2020 - Breakthrough designation helps advance the therapy targeting a significant unmet need in the treatment of neonatal opioid ...
Posted by Michael Wonder on 16 Dec 2020
Exero Medical's smart sensor granted FDA breakthrough designation
15 December 2020 - Designation to expedite regulatory clearance process for Exero Medical's system, providing data on internal tissue healing in ...
Posted by Michael Wonder on 15 Dec 2020
FDA awards Genetesis breakthrough device designation for CardioFlux imaging technology
15 December 2020 - Genetesis announced today that its flagship product, CardioFlux, has been granted Breakthrough Device Designation by the U.S. ...
Posted by Michael Wonder on 10 Dec 2020
SoniVie receives FDA breakthrough device designation for the TIVUS system for renal artery denervation
9 December 2020 - SoniVie acquires new intellectual property and other assets from Cardiosonic Moving TIVUS into new therapeutic areas beyond ...
Posted by Michael Wonder on 09 Dec 2020
ReGelTec receives FDA breakthrough designation for its Hydrafil system
9 December 2020 - ReGelTec announced today that it has received breakthrough device designation from the Center for Devices and Radiological ...
Posted by Michael Wonder on 08 Dec 2020
Carlsmed aprevo granted unprecedented decision by FDA
8 December 2020 - -Carlsmed today announced it has been granted 510(k) clearance and breakthrough device designation by the FDA for ...
Posted by Michael Wonder on 30 Nov 2020
FDA approves device for treatment of osteoid osteoma in the extremities
27 November 2020 - The FDA approved the Sonalleve MR-HIFU system (Profound Medical) for the treatment of osteoid osteoma in ...
Posted by Michael Wonder on 20 Nov 2020
FDA grants breakthrough designation to 4D Path for novel cancer diagnostic solution
18 November 2020 - 4D Path today announced that the U.S. FDA has granted the company breakthrough device designation for ...
Posted by Michael Wonder on 20 Nov 2020
Lumicell granted fast track designation approval by the FDA for breast cancer treatment
18 November 2020 - Fast track designation augments previously granted breakthrough device designation. ...