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Diagnostics

Octave Bioscience’s Multi-Biomarker Test Provides Key Insights To Predict Multiple Sclerosis Disease State

Octave Bioscience’s CEO Doug Biehn sat down with Medtech Insight at HLTH to talk about the company’s plans for expanding their multivariate biomarker blood test for MS analysis and development of a diagnostic for Parkinson’s disease.

Digital Health Roundup: GE HealthCare On AI At HLTH; Medtech Conference Panel; Graphene Brain Implant; Unicorns & More

In this week’s Digital Health Roundup, Medtech Insight’s Marion Webb talks about her interview with GE HealthCare’s chief AI officer Parminder Bhatia about his vision for AI in health care and other highlights from HLTH. Natasha Barrow discusses her interview with Owkin on the EU AI Act and highlights Click Therapeutics’ latest clinical results.

News We’re Watching: HistoSonics Secures $90M VA Deal, CRC Blood Test Deemed Less Cost-Effectiveness, More

This week, HistoSonics announced it will bring its ultrasound system for destroying liver tumors into VA hospitals, Edwards Lifesciences reports encouraging TRISCEND II trial results at TCT, study finds blood test for CRC screening are less cost-effective than alternatives, and more.

HLTH 2024: GE HealthCare’s Chief AI Officer Says Future Of AI No Longer A Black Box

Medtech Insight talked with GE HealthCare’s chief AI officer Parminder “Parry” Bhatia at HLTH about the firm’s new CareIntellect for Oncology offering to help clinicians make efficient use of multimodal patient data, his vision for projects within AI Innovation Lab, and the future of AI in health care.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

FDA Publishes Updated Roadmap For Advancing Women’s Health

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

News We’re Watching: J&J Buys V-Wave, Procept Plans Aquablation Trial, TriClip Up For Medicare Coverage

This week, J&J announced that it was buying heart failure device firm V-Wave; Procept got the FDA’s OK on a clinical trial of its Aquablation treatment for prostate cancer; and CMS began to consider Medicare reimbursement of Abbott’s TriClip tricuspid repair device.

College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

De Novo Clearance For HealGen Flu/COVID-19 Test

FDA grants de novo authorization to Healgen Rapid Check COVID-19/Flu A&B Antigen Test, making it the first OTC flu test to be cleared outside the emergency use pathway.

Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.