Diagnostics

Biologics
Diagnostics

IBA swings to profit in H1 2026 as proton therapy orders surge

The Belgian particle accelerator group posted a €9.3m net profit in H1 2026, reversing a prior-year loss, with proton therapy order intake more
The Belgian particle accelerator group posted a €9.3m net profit in H1 2026, reversing a prior-year loss, with proton therapy order intake more
Diagnostics
Digital Health

Heartflow FFRCT cuts unnecessary heart catheterisations by 44%

Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Independent Dutch government-funded FUSION trial found adding Heartflow's AI analysis to standard CT scans halved avoidable invasive coronary procedures at one year.
Diagnostics

Philips and Imricor launch combined cardiac iMR lab solution

The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
The partners have commercialised a 1.5T MRI-based interventional lab for cardiac ablation, removing reliance on X-ray fluoroscopy in CE-marked markets.
Diagnostics

Quoin Pharmaceuticals raises up to $50m in private placement

The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
The rare-disease specialist said upfront proceeds of $30.8m, plus warrants, will fund its Netherton Syndrome programme into the second half of 2029.
Diagnostics

Conavi Medical wins FDA 510(k) for hybrid IVUS-OCT imaging system

The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
The Toronto-based medical device firm secured FDA clearance for its Novasight Hybrid platform and targets first U.S. hospital placements in H2 2026.
Diagnostics

Verrica completes COVE-2 enrolment for YCANTH common warts label

Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
Verrica Pharmaceuticals has finished enrolling its first pivotal Phase 3 warts trial, with topline data expected in Q1 2027 and a second trial over 50
Digital Health
Diagnostics

Trimedx adds agentic AI to TMX Protect to cut device cyber remediation

Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Trimedx says new natural-language AI capabilities in TMX Protect cut medical device cybersecurity remediation time by 75% on average.
Diagnostics

BridgeBio doses first patient in ASCEND-ATTR Phase 3b/4 study

BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
BridgeBio has initiated ASCEND-ATTR, a 150-patient study testing whether long-term acoramidis can reverse cardiac damage in ATTR-CM.
Diagnostics

Femasys brings FemaSeed portfolio to UNC Health OB/GYN network

Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Femasys and UNC Health have partnered to offer in-office fertility diagnostics and intratubal insemination across the academic system's statewide OB/GYN locations.
Diagnostics

RenovoRx publishes PK/PD data showing 51% tumour-site drug extraction

Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Peer-reviewed sub-study data from the Phase III TIGeR-PaC trial supports the TAMP platform's targeted delivery mechanism in locally advanced pancreatic cancer.
Diagnostics

SeaStar Medical grows QUELIMMUNE revenue 82% as adult AKI trial advances

SeaStar Medical added three top-rated children's hospitals to its QUELIMMUNE customer base and enrolled 223 of 339 patients in its adult AKI pivotal
SeaStar Medical added three top-rated children's hospitals to its QUELIMMUNE customer base and enrolled 223 of 339 patients in its adult AKI pivotal
Diagnostics

Vivos Inc. ships first IsoPet batches from in-house US facility

Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
Vivos has begun domestic IsoPet shipments from its Richland, WA site and secured Indian nuclear regulatory approval for a second international manufacturing centre.
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.
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

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.
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

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

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
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.
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