Diagnostics

Biolinq plans to use the proceeds of its new venture funding to support US FDA de novo review, automation engineering and commercialization efforts with partners, CEO Rich Yang told Medtech Insight.

Reimagine Care teamed up with MedStar Health to support cancer patients at home via an AI assistant and clinical support. Reimagine Care’s data suggests its platform can save cancer centers up to $1m annually per full-time oncologist panel and reduce ED visits by 30%.

Freenome plans to file for US FDA approval of its blood-based screening test for colorectal cancer mid-year. If cleared, the test would rival Guardant Health’s Shield, the first FDA-cleared blood test for primary screening of colorectal cancer. Exact Sciences is also in the race to bring a blood-based colorectal screening test to market.

Farideh Bischoff, chief medical officer of Heranova Lifesciences, discusses the urgent need for better diagnostic options and the latest innovations transforming care for endometriosis patients.

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.

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.

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 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.

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.