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Diagnostics

EU Law First Up As UK MHRA Reopens Work On Pre-Market Medtech Regulation

Assimilated EU medtech law used in Great Britain will not be sunsetted on 26 May 2025, as originally provided for. That was the first decision published by the MHRA in the wake of its recent consultation on shaping the regulatory system.

A Blueprint For The Future: Germany’s Medtech Sees Chance In More Government Roundtables

Germany’s government-industry healthcare industry roundtables have yielded a final report, even though the program was curtailed by the snap election. The new CDU-led government should pick up the baton, medtech industry associations say.

Financing Quarterly Statistics, Q4 2024

During Q4, biopharmas brought in an aggregate $16.8bn in financing and device company fundraising totaled $2.3bn; while in vitro diagnostic firms and research tools players raised $294m.

PharmStars’ Founder Aims To Bridge ‘Pharma Start-Up Gap’; Alumni Are Ready To Pounce On Pharma Deal

PharmStars CEO Naomi Fried spoke with Medtech Insight about the Boston-based virtual accelerator, which brings together digital health-focused start-ups with pharmaceutical companies to accelerate deals. Executives from Elemeno Health, Head Diagnostics and JOGO Health who participated in the PharmaU program and final pitching event to PharmStars’ pharma members talked about their experiences, the value proposition and challenges in securing a pharma deal.

Boston Scientific’s Head Of Urology Says Axonics Acquisition ‘Brings A More Comprehensive Gender Balance’

Medtech Insight spoke with Meghan Scanlon, president of Boston Scientific’s urology division, about integration plans for the recently acquired Axonics medtech. The purchase adds sacral neuromodulation to Boston Scientific’s portfolio, a global market that research reports valued at $1.6bn in 2023.

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.