Diagnostics

Diagnostics

Tarsus Pharmaceuticals closes oversubscribed $125m PIPE financing

The Irvine-based eye care biotech raised the funds alongside a pending acquisition of Alkeus Pharmaceuticals, with Bain Capital Life Sciences among participating
The Irvine-based eye care biotech raised the funds alongside a pending acquisition of Alkeus Pharmaceuticals, with Bain Capital Life Sciences among participating
Diagnostics

Tarsus Pharmaceuticals raises XDEMVY guidance after 69% sales surge

The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
The Irvine-based eye care company reported record Q2 sales of $173.9m for XDEMVY and announced a deal to acquire Alkeus Pharmaceuticals for its
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Diagnostics
Digital Health
Biotech

Sigrid Therapeutics lists SiPore® range on Fullscript platform

The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
The Stockholm-based company's gut-local metabolic health products are now accessible to more than 125,000 US practitioners via Fullscript.
Diagnostics

Biodesix posts 34% revenue growth in Q2 2026 on lung test volumes

The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
The Colorado-based lung diagnostics company reported $26.9m in Q2 revenue and maintained full-year guidance of $108–114m.
Diagnostics

Black Diamond reports 86% CNS response rate for silevertinib in NSCLC

Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Phase 2 data show silevertinib achieved a 60% ORR and 86% CNS response in frontline non-classical EGFRm NSCLC, with no de novo brain metastases
Diagnostics

Eton Pharmaceuticals licenses ASN-001 to broaden hemangioma portfolio

Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Eton has acquired US rights to topical timolol gel ASN-001, targeting moderate infantile hemangiomas with an NDA filing planned for late 2027.
Diagnostics

Molecure KITE trial clears interim review with no protocol changes

An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
An IDMC review of 30 patients found sufficient probability of hitting the primary endpoint, letting the Phase II sarcoidosis study proceed unchanged.
Diagnostics

Sight Sciences wins FDA 510(k) clearance for OMNI Ultra glaucoma system

The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
The Menlo Park eyecare company cleared its next-generation implant-free MIGS device and is targeting a US commercial launch in Q4 2026.
Diagnostics
Digital Health

Eyonis and Olea Medical partner to expand AI lung cancer screening in US

Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Median Technologies' Eyonis will distribute its FDA-cleared eyonis LCS tool through Canon Medical subsidiary Olea Medical across the US and Europe.
Diagnostics

CorVascular launches ASUS handheld ultrasound range at SVU 2026

CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
CorVascular has introduced the FDA-cleared ASUS LU800 handheld ultrasound to US vascular specialists at the SVU annual conference in Maryland.
Digital Health
Diagnostics

First Choice Healthcare to go public via Westin SPAC at $650m valuation

First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
First Choice Healthcare Solutions will merge with Westin Acquisition Corp to list on Nasdaq as Wellgevity 360, valued at approximately $650 million.
Diagnostics

MMI wins FDA clearance to expand REMIND Alzheimer's robot surgery study

MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
MMI's IDE supplement approval lets the REMIND study enrol up to 15 patients, testing robotic microsurgery to restore lymphatic drainage in Alzheimer's disease.
Diagnostics
Genomics

BioNexus advances VitaGuard MRD rollout across Southeast Asia

BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
BioNexus Gene Lab Corp. is targeting 2026 deployment of its VitaGuard liquid-biopsy platform in Malaysia and Singapore after a technical visit to its Chinese
Diagnostics

Conavi Medical prices C$10m–C$15m public offering for US launch

The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
The Toronto-listed cardiovascular imaging company is raising up to C$15m to fund a limited US market release of its hybrid IVUS-OCT system.
Diagnostics
Digital Health

Profusa signs option to acquire diagnostics group G3 Vision Labs

The NASDAQ-listed biosensing company has secured an option to buy G3 Vision Labs, which reported around $111m in 2025 net revenues.
The NASDAQ-listed biosensing company has secured an option to buy G3 Vision Labs, which reported around $111m in 2025 net revenues.
Diagnostics

InnSight Technology wins $515k from Mellon Foundation for OcuCheck

Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Pittsburgh diagnostics firm InnSight secured a $515,000 social impact investment to advance its tear-fluid diabetes screening device toward commercialisation.
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
Biologics
Digital Health
Diagnostics

Clue data study links follicular-phase vaccination to more side effects

Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Research using Clue app data suggests menstrual cycle phase at vaccination may influence COVID-19 vaccine side effects and subsequent infection timing.
Diagnostics

Sonablate highlights 10-year HIFU focal therapy data from 3,477 patients

A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
A European Urology study of UK registry data found 0.1% prostate cancer-specific mortality and 3% metastatic progression at 10 years for focal HIFU.
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