Diagnostics

Medical Devices
Diagnostics

Philips launches FDA-cleared eV14-2v single-transducer for OB/GYN

Philips has introduced a transvaginal transducer claiming a 41.7% penetration gain and 22% weight reduction over its predecessor, with dual regulatory clearance.
Philips has introduced a transvaginal transducer claiming a 41.7% penetration gain and 22% weight reduction over its predecessor, with dual regulatory clearance.
Pharmaceuticals
Genomics
Diagnostics

Tarsus Pharmaceuticals completes Alkeus buy, adds Stargardt drug

Tarsus gains worldwide rights to Phase 3 oral candidate ALK-001 for Stargardt disease, a blinding inherited retinal condition with no approved therapy.
Tarsus gains worldwide rights to Phase 3 oral candidate ALK-001 for Stargardt disease, a blinding inherited retinal condition with no approved therapy.
Diagnostics
Genomics

Kala Bio signs exclusive US deal for Virotek eye genetics tests

Kala Bio will be the sole US distributor of Virotek's ophthalmology genomic testing programme under a one-year deal effective 4 September 2026.
Kala Bio will be the sole US distributor of Virotek's ophthalmology genomic testing programme under a one-year deal effective 4 September 2026.
Pharmaceuticals
Biologics
Diagnostics

Cosmos Health posts record H1 revenue of $36.9m, retires debt early

The NASDAQ-listed healthcare group reported 29.7% revenue growth in H1 2026 and repaid an $8m convertible note twelve months ahead of schedule.
The NASDAQ-listed healthcare group reported 29.7% revenue growth in H1 2026 and repaid an $8m convertible note twelve months ahead of schedule.
Medical Devices
Diagnostics
Biotech

Magrabi Health earns first global SRC Network of Excellence in

The Saudi-founded eye care group becomes the first healthcare network worldwide to receive the Surgical Review Corporation's specialist ophthalmology network
The Saudi-founded eye care group becomes the first healthcare network worldwide to receive the Surgical Review Corporation's specialist ophthalmology network
Pharmaceuticals
Medical Devices
Diagnostics

PRF Technologies clears IND for OcuRing-K Phase II cataract trial

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain
Medical Devices
Diagnostics

AiM Medical Robotics wins $2m NCI grant for MRI brain robot

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.
Medical Devices
Diagnostics

Alpha Tau completes 48-patient IMPACT pancreatic cancer enrolment

Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Alpha Tau Medical has finished enrolling 48 patients in its IMPACT pilot study of Alpha DaRT for unresectable pancreatic cancer, with data expected in early
Pharmaceuticals
Diagnostics

BioVie completes treatment phase of bezisterim Long COVID trial

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.
Diagnostics
Medical Devices
Regulatory Science

Intelligent Bio Solutions hits 98% accuracy ahead of 510(k) filing

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission
Diagnostics
Genomics
Pharmaceuticals

Kala Bio signs LOI to distribute Virotek ophthalmic genetic tests

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.
Diagnostics
Pharmaceuticals

Telix completes BiPASS enrolment and aligns with FDA on NDA path

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could
Diagnostics
Pharmaceuticals
Biologics

Juniper's JBS-003 wins FDA Breakthrough Therapy Designation

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.
Digital Health
Diagnostics

Discovery Health data shows women lead Personal Health Pathways uptake

Discovery Health reports female members complete 1.5 times more preventive health actions than male members on its AI-powered Personal Health Pathways platform.
Discovery Health reports female members complete 1.5 times more preventive health actions than male members on its AI-powered Personal Health Pathways platform.
Digital Health
Diagnostics

XYRA doses first European patient in budiodarone AF trial

XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic
Biologics
Diagnostics

Acoramidis shows structural cardiac reversal in 54-month ATTR-CM data

BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
BridgeBio's Attruby generated CMR evidence of cardiac structural reversal and 65 extra days alive out of hospital at three years in ATTR-CM patients.
Diagnostics

Autonomix Medical secures US patent on feedback-guided neuromodulation

Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Autonomix Medical has been granted a US patent covering real-time feedback-guided precision neuromodulation systems, including neural ablation for cancer pain relief.
Diagnostics
Biologics

Trinity Biotech faces Nasdaq delisting risk amid diagnostics overhaul

Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
Dublin-based Trinity Biotech has requested a Nasdaq hearing after failing to meet the exchange's minimum market value threshold by its August deadline.
Diagnostics
Digital Health

CapsoVision posts 10% revenue growth as AI Highlights eyes FDA clearance

The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.
The capsule endoscopy company reported Q2 2026 revenue of $3.6m and expects US clearance of its AI-assisted reading tool by end of Q3.
Diagnostics
Regulatory Science
Biologics

hVIVO acquires CRS Berlin to enter dermatology and women's health

hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
hVIVO has bought the Berlin-based Phase I/II unit for a nominal upfront fee plus a revenue-linked earnout capped at roughly €6 million.
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