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RSS FeedPosted 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 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program. ...
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 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...
Posted by Michael Wonder on 30 Nov 2020
Zymeworks receives FDA breakthrough therapy designation for HER2-targeted bispecific antibody zanidatamab in patients with biliary tract cancer
30 November 2020 - Zymeworks today announced that the U.S. FDA has granted breakthrough therapy designation for zanidatamab in patients with ...
Posted by Michael Wonder on 24 Nov 2020
PolyPid granted breakthrough therapy designation from FDA for D-PLEX for the prevention of surgical site infections in colorectal surgery
24 November 2020 - PolyPid Ltd today announced that D-PLEX100 has received breakthrough therapy designation from the U.S. FDA for the ...
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 17 Nov 2020
ViiV Healthcare receives FDA breakthrough therapy designation for investigational, long-acting cabotegravir for HIV prevention
17 November 2020 - ViiV Healthcare today announced that the US FDA has granted breakthrough therapy designation for long-acting, injectable cabotegravir ...
Posted by Michael Wonder on 17 Nov 2020
Sommetrics receives FDA breakthrough device designation for its aerSleep II product to treat sleep apnea
17 November 2020 - Sommetrics today announced its lead sleep apnea product, aerSleep II, has received FDA breakthrough device designation. ...
Posted by Michael Wonder on 17 Nov 2020
Kiniksa announces breakthrough therapy designation granted to vixarelimab for the treatment of pruritus associated with prurigo nodularis
16 November 2020 - Kiniksa Pharmaceuticals today announced that the U.S. FDA granted breakthrough therapy designation to vixarelimab for the ...
Posted by Michael Wonder on 12 Nov 2020
FDA grants a breakthrough device designation for Spiderwort spinal cord technology
12 November 2020 - Spiderwort is pleased to announce that the U.S. FDA has designated CelluBridge, Spiderwort’s spinal cord scaffold implant, ...