Skip to content Skip to footer
Subscribe Now
NEWS

Caris Launches Caris MI Clarity for AI-Powered Breast Cancer Recurrence Risk Assessment

Shots: Caris has launched Caris MI Clarity, an AI-driven prognostic test for postmenopausal pts with HR+/HER2-, node-negative early-stage breast cancer, designed to assess both early (0–5yrs.) & late (5–15yrs.) distant recurrence risk from a single test at diagnosis The test leverages Caris’ multimodal dataset, computational pathology & AI-driven ML to analyze digitized H&E slides and…
May 6, 2026

Read more

NEWS

Multi4 Medical Receives CE Mark Approval for Multi4 System to Perform Outpatient Bladder Cancer Treatment

Shots: Multi4 Medical received CE mark approval for the Multi4 System, an all-in-one bladder cancer treatment platform enabling treatment during the same outpatient visit without operating room use, anesthesia, or hospitalization The Multi4 instrument integrates local anesthesia delivery, tumor resection, automatic tissue extraction for pathology, & cauterization into a single endoscopic device, allowing awake pts…
May 6, 2026

Read more

NEWS

Ortho Development Launches Trivicta Cementless Hip Stem for Primary Hip Arthroplasty

Shots: Ortho Development has reported the full US commercial launch of the Trivicta Hip Stem, a cementless triple-taper femoral component for primary total hip arthroplasty, following a controlled market introduction Trivicta system features a 35μm hydroxyapatite coating over sintered titanium beads to support early osteointegration, alongside standard & extended offset options, progressive neck lengths, &…
May 5, 2026

Read more

NEWS

Insulet Enrolls First Patient in the EVOLVE Study of its FCL Omnipod M System for Type 2 Diabetes

Shots: Insulet has enrolled the first patient in its EVOLVE study to evaluate safety & efficacy of its fully closed-loop (FCL) Omnipod M System, an automated insulin delivery system for T2D vs standard therapy Trial will assess the system in ~350 T2D pts (18-75yrs.) using insulin (basal-bolus or basal-only), across the US, with prior feasibility data (presented…
May 5, 2026

Read more

NEWS

Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant) Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…
May 5, 2026

Read more

NEWS

Guardant Health and Nuvalent Partner on Precision Oncology Diagnostics

Shots: Guardant Health has entered into a multi-year strategic collaboration with Nuvalent to support the development & potential commercialization of Nuvalent’s oncology pipeline using the Guardant Infinity platform The partnership will use Guardant’s tissue & liquid biopsy tests to support Nuvalent’s global clinical studies & evaluate companion diagnostic development for Nuvalent’s investigational cancer therapies The…
May 1, 2026

Read more

NEWS

CareDx to Acquire Naveris for ~$260M

Shots: CareDx has entered into a definitive agreement to acquire Naveris, extending CareDx’s Precision Medicine Testing Services strategy into specialty oncology As per the deal, CareDx will acquire Naveris for $160M upfront & up to $100M in revenue milestones; closing is expected in Q3’26 Naveris’ liquid biopsy platform uses TTMV DNA to detect viral DNA…
April 29, 2026

Read more

NEWS

Pixee Medical’s Knee+ NexSight Receives the US FDA 510(k) Clearance for Knee Arthroplasty

Shots: The US FDA has granted 510(k) clearance to Knee+ NexSight, its AR-based total knee arthroplasty solution Knee+ NexSight projects a virtual display with voice control during knee arthroplasty, without the need of robot, console, or disposables, while delivering robotic-level accuracy with less invasive tools, reduced blood loss, & seamless workflow integration Knee+ NexSight supports…
April 28, 2026

Read more

NEWS

Motif Neurotech Receives FDA IDE Approval to Initiate RESONATE Trial of Motif XCS System in Treatment-Resistant Depression

Shots: The US FDA has granted IDE approval to initiate RESONATE Early Feasibility Study of Motif XCS System in pts with treatment-resistant depression, who have received ≥2 medications The trial will assess 12mos. safety of Motif XCS System & procedure post-implantation & measure symptom reduction, quality of life, anxiety, & cognitive function using standard assessments…
April 27, 2026

Read more

Load more