Friday Five: Otsuka Click-s into depression DTx market, Verily jumps on board; Prenosis' sepsis AI bags FDA first; and more
Friday Five
By: Tina Tan
Ref: Friday Five
Published: 04/04/2024

Will Rejoyn be joining docs’ depression armamentarium?
- A five-year collaboration between Otsuka and Click Therapeutics has culminated in the two companies’ winning FDA clearance for Rejoyn, said to be the first prescription digital therapeutics for treating major depressive disorder (MDD) symptoms.
- The smartphone-based six-week programme can be prescribed as an adjunct to pharmacotherapy and indicated for patients ages 22 years and older.
- The programme combines a cognitive behavioural therapy component with a proprietary technique, known as Emotional Faces Memory Task. The latter is described as “physical therapy for the brain” and works by by targeting and modifying neural connections essential for appropriately processing emotions.
- Otsuka and Click won the marketing authorisation based on data from its pivotal trial MIRAI, but is it enough to win over physicians? FirstWord launched a snap-poll to find out - click here to be notified of results.
Verily gets on board Otsuka’s mental health journey
- Otsuka has enlisted Verily to help it recruit participants and run a newly launched longitudinal registry study that aims to advance research in depression and mental health.
- The My Mental Health Journey registry will enroll US-based adults experiencing symptoms of depression to help Otsuka better understand mental health conditions like major depressive disorder, for which its Rejoyn prescription DTx just got FDA-cleared.
- Participants in this observational study will share their unique depression journeys through periodic, self-guided assessments and digital data collection.
- Verily will deploy Viewpoint, an end-to-end suite of solutions that powers evidence generation, to run My Mental Health Journey.
Prenosis makes early sepsis Dx a reality
- The FDA has green-lighted Prenosis’ Sepsis ImmunoScore software, making it the first AI diagnostic tool for this life-threatening condition cleared in the US.
- The tool leverages a combination of biomarkers and clinical data, employing AI to evaluate whether sepsis is present or progressing within 24 hours of a patient's assessment in the emergency department or hospital.
- Sepsis ImmunoScore is not an alert system, but is designed to assess a patient's biological status to generate a risk score to reflect their likelihood of deterioration and the need for escalated care, among other things.
- Prenosis’ de novo marketing authorisation caps off a flurry of news around advances made in making early sepsis detection a reality, including positive data from a study by Lund University researchers on combining a simple blood test with AI to improve sepsis diagnosis.
Philips opens up with smartQare
- In line with its strategy to improve accessibility to new technology by offering vendor-agnostic solutions, Philips has forged an agreement with fellow Dutch company smartQare to enhance its patient monitoring offering.
- smartQare will acquire Philips’ Healthdot business, combining the wearable biosensor with smartQare’s multisensor continuous patient monitoring solution, viQtor, via a single digital platform.
- The two companies will jointly offer the integrated remote patient monitoring solution to healthcare providers and patients.
- “By moving away from proprietary standards and closed systems to an open patient monitoring infrastructure, clinicians are free to use third-party devices and wearables of choice that communicate effortlessly across the platform,” commented Philips.
GE turbocharges Vscan with AI
- GE HealthCare will be showcasing its improved Vscan Air SL pocket-sized handheld ultrasound, now with AI-powered features to support faster cardiac assessments, at the upcoming American College of Cardiology scientific conference.
- The software integrated into the device comes from Caption Health, which GE acquired last year; it provides real-time visual guidance to ensure the best possible images are captured and the AutoEF feature automatically calculates the left ventricular ejection fraction.
- Roland Rott, CEO of GE HealthCare's ultrasound business, said the integrated technology "opens an entirely new chapter for cardiac screening" that supports earlier detection of cardiac disease.
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