Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2022
FDA grants breakthrough device designation to VR mental illness treatment
22 June 2022 - A British startup that uses virtual reality to help deliver cognitive behaviour therapy has been granted a ...
Posted by Michael Wonder on 14 Jun 2022
FDA should step in to help spur AI/ML standards
13 June 2022 - The US FDA should support the burgeoning integration of artificial intelligence and machine learning in medical ...
Posted by Michael Wonder on 26 May 2022
Revolutionary wearable ultrasound device gains FDA approval
26 May 2022 - ManaMed has been granted FDA approval on its latest orthopaedic recovery device, ManaSport. ...
Posted by Michael Wonder on 21 May 2022
Bonesupport receives market authorisation for Cerement G in the US
18 May 2022 - BoneSupport today announced that the company has received market authorisation from the U.S. FDA, for the ...
Posted by Michael Wonder on 19 May 2022
NeuroMetrix reports that Quell wearable neuromodulation device has received FDA de novo authorisation as first non-pharmacological treatment for fibromyalgia
19 May 2022 - NeuroMetrix today announced U.S. FDAde novo authorisation to market the Quell neuromodulation device as an ...
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 08 May 2022
Wearable technology promises to revolutionise health care
5 May 2022 - Do not let bureaucracy delay matters. ...
Posted by Michael Wonder on 04 May 2022
FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease
4 May 2022 - The U.S. FDA today permitted marketing for the firstin vitro diagnostic test for early detection ...
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. ...