Diagnostics

Diagnostics

Milestone Pharma starts Phase 3 trial of etripamil for AFib-RVR

Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with
Milestone Pharmaceuticals has enrolled the first patient in ReVeRA-301, a pivotal Phase 3 study of self-administered etripamil nasal spray for atrial fibrillation with
Diagnostics
Regulatory Science

FDA clears Vitestro's Aletta robotic blood draw device via De Novo

The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
The FDA has authorised the first standalone robotic phlebotomy device, cleared via De Novo pathway, to address a growing shortage of trained phlebotomists.
Diagnostics

TearCare wins FDA label update to improve meibomian gland function

Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
Sight Sciences says TearCare is now the first MGD treatment indicated to improve meibomian gland function in evaporative dry eye patients.
Digital Health
Diagnostics

AliveCor KardiaMobile 6L nearly doubles arrhythmia detection in trial

A 350-patient prospective study found the handheld 6-lead ECG device detected arrhythmias in 14.9% of patients versus 7.7% for standard ambulatory
A 350-patient prospective study found the handheld 6-lead ECG device detected arrhythmias in 14.9% of patients versus 7.7% for standard ambulatory
Diagnostics

Zentalis plots DENALI Part 2 readout in 1H 2027 as cash thins

Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.
Zentalis said FDA alignment on its accelerated approval strategy for azenosertib in Cyclin E1-positive ovarian cancer keeps a 2027 filing pathway open.
Diagnostics

Senseonics raises CGM revenue guidance after 120% Q2 growth

Senseonics lifted its full-year 2026 revenue target to $62–66 million after record quarterly revenue and gross margins beat its own guided range.
Senseonics lifted its full-year 2026 revenue target to $62–66 million after record quarterly revenue and gross margins beat its own guided range.
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
Regulatory Science

Spectral Medical's PMX enters FDA substantive review for septic shock

The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.
The Toronto-listed theranostic company said 12-month Tigris trial data showed a 13.9% absolute mortality reduction versus standard care.
Diagnostics

Clearmind DSMB clears CMND-100 to advance into AUD patients

Clearmind Medicine's Phase I/II trial of CMND-100 can progress to patient cohorts after its safety board unanimously approved advancement following a clean
Clearmind Medicine's Phase I/II trial of CMND-100 can progress to patient cohorts after its safety board unanimously approved advancement following a clean
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
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
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

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

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

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

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

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
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.
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