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RSS FeedPosted by Michael Wonder on 27 May 2022
FDA grants breakthrough device designation for Emily's Care Nourish Test System
26 May 2022 - Lactation Lab has announced today that the U.S. FDA, has granted the company breakthrough device designation ...
Posted by Michael Wonder on 24 May 2022
FDA grants breakthrough device designation to Anumana’s ECG pulmonary hypertension early detection AI algorithm
24 May 2022 - Anumana today announced that the U.S. FDA has granted breakthrough device designation to its AI-enhanced, ECG based ...
Posted by Michael Wonder on 18 May 2022
Exactech announces FDA breakthrough device designation for JointMedica’s Polymotion hip resurfacing system
17 May 2022 - Exactech announced that the U.S. FDA has granted a breakthrough device designation for JointMedica’s Polymotion hip ...
Posted by Michael Wonder on 18 May 2022
VenoStent technology receives breakthrough device designation by FDA
17 May 2022 - Designation to promote more rapid agency and market access for VenoStent. ...
Posted by Michael Wonder on 12 May 2022
FDA grants breakthrough device designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of fibromyalgia
12 May 2022 - On World Fibromyalgia Awareness Day (May 12), the French startup Remedee Labs is announcing that the FDA ...
Posted by Michael Wonder on 12 May 2022
Wysa receives FDA breakthrough device designation for AI led mental health conversational agent
12 May 2022 - New peer-reviewed studies demonstrate efficacy in managing chronic pain, depression and anxiety ...
Posted by Michael Wonder on 10 May 2022
Turning Point Therapeutics granted breakthrough therapy designation for repotrectinib treatment in patients with one prior ROS1 tyrosine kinase inhibitor and no prior chemotherapy
10 May 2022 - Turning Point Therapeutics today announced the U.S. FDA granted an eighth regulatory designation, and third breakthrough therapy ...
Posted by Michael Wonder on 04 May 2022
X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device
3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted ...
Posted by Michael Wonder on 04 May 2022
Mirvie receives FDA breakthrough device designation for first test designed to indicate risk of preeclampsia months before symptoms occur
3 May 2022 - Breakthrough has the potential to address a leading cause of maternal mortality that impacts millions of ...
Posted by Michael Wonder on 04 May 2022
SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients
3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with ...
Posted by Michael Wonder on 03 May 2022
Limaca Medical receives FDA breakthrough device designation
2 May 2022 - Limaca's precision GI endoscopic biopsy device advances precision medicine. ...
Posted by Michael Wonder on 02 May 2022
SpineX receives FDA breakthrough device designation for SCiP
2 May 2022 - SpineX’s proprietary non-surgical device SCiP offers new hope for children with cerebral palsy. ...
Posted by Michael Wonder on 28 Apr 2022
Nocira becomes first company ever to announce breakthrough device designation by the FDA for acute treatment of migraine
27 April 2022 - Nocira's hand held device that uses gentle, controlled puffs of air in the ears for treating migraine ...
Posted by Michael Wonder on 27 Apr 2022
T2 Biosystems announces submission for FDA breakthrough device designation for T2Biothreat Panel
27 April 2022 - T2 Biosystems announced today that it has submitted an application with the U.S. FDA for breakthrough device ...
Posted by Michael Wonder on 27 Apr 2022
Enhertu granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer
27 April 2022 - Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free ...