Development Life Science Radiology Regulation 
pharmaphorum
DECEMBER 11, 2022
It can mean everything from patient-facing disease management apps and wearables to background AI dramatically altering drug discovery or radiological imaging. As we develop these technologies, it’s not only that we must focus on the patient experience; we need to start with the patient experience,” Hadjiat tells pharmaphorum.
XTalks
SEPTEMBER 9, 2022
The California-based medical device company develops brain stimulation technology to treat neuropsychiatric disorders. Related: Xtalks Voices: Magnus Medical CEO Dr. Brett Wingeier Talks About Neurostimulation for Depression – Xtalks Life Science Podcast Ep. The SAINT Neuromodulation Trial.
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pharmaphorum
OCTOBER 4, 2022
On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.
Delveinsight
SEPTEMBER 2, 2021
This designation was based on positive clinical data from the first 21 Impella ECP patients treated as part of an FDA-regulated early feasibility study and will give priority during the Impella ECP’s regulatory review processes comprising of design iterations, clinical study protocols, and pre-market approval (PMA) application.
XTalks
NOVEMBER 7, 2022
In addition, Dr. Bahassi stressed that the simple enumeration of CTCs will not contribute significantly to the development of improved or more personalized cancer treatments. During the webinar, Dr. Bahassi gave a brief schematic of how personalized, targeted assays can be developed to detect somatic mutations from cfDNA ( Figure 1 ).
XTalks
MAY 13, 2022
Container closure systems are highly regulated by health agencies. With a network including North America, Europe and Asia, Curia aims to improve patient outcomes and quality of life by offering a complete suite of solutions across its three divisions: Discovery, Development and Analytical (DDA), Drug Product and API Manufacturing.
XTalks
AUGUST 30, 2022
One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Why is it Difficult to Develop CNS Therapeutics? Intrathecal Drug Systems are an Important Pain Treatment Modality.
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