Regulation

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.
Biologics
Regulatory Science

Sanofi's MenQuadfi wins EU approval for infants from six weeks

The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.
The European Commission has expanded MenQuadfi's indication to cover infants from six weeks, extending protection against four meningococcal serogroups.

Beyond Air raises up to $30.1m to fund LungFit PH II launch

Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
Beyond Air priced an at-the-market private placement to fund the commercial launch of its second-generation nitric oxide delivery system, pending FDA approval.
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.
Biologics

DBV Technologies raises $50m via ATM programme with RA Capital

The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
The French peanut-allergy biotech sold 3.66 million new ADSs at $13.67 each to RA Capital, diluting existing shareholders by approximately 5.82%.
Biologics

EPO upholds SOT201 patent for SOTIO's PD-1 immunocytokine

SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
SOTIO Biotech's IL-15 immunocytokine patent survived a Sanofi-led appeal, reinforcing IP around a Phase 1 programme showing objective responses in heavily pre
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.

Integra LifeSciences Q2 revenue steady as SurgiMend relaunch nears

Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Integra posted $418.8m in Q2 revenue and confirmed production at its Braintree facility, setting up a fourth-quarter SurgiMend relaunch.
Biologics
Regulatory Science

Leads Biolabs wins IND approval for Opamtistomig in metastatic CRC

China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
China's NMPA cleared a Phase Ib/II trial of the PD-L1/4-1BB bispecific in MSS colorectal cancer, where checkpoint inhibitors have largely
Genomics

Medicus Pharma wins UAE IND nod for genomics-guided endometriosis trial

Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
Medicus Pharma has received UAE DOH authorisation to begin PRECISION-E2, a Phase 2a genomics-integrated study of Teverelix in 84 women with endometriosis.
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.
Regulatory Science

UroGen secures US patent protecting ZUSDURI to July 2044

UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
UroGen Pharma has received a USPTO Notice of Allowance covering its RTGel-based mitomycin treatment for recurrent bladder cancer, extending exclusivity to 2044.
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.
Regulatory Science

MIRA Pharmaceuticals advances MIRA-55 and SKNY-1 toward IND studies

MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling
MIRA Pharmaceuticals has completed exploratory toxicology dosing in rats and dogs for both its pain and obesity candidates, bringing them closer to formal IND-enabling

SynCardia reveals Emperor TAH architecture at IEEE EMBC 2026

Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
Picard Medical's SynCardia made the first public disclosure of its next-generation electromechanical total artificial heart architecture at IEEE EMBC in Toronto.
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.
Regulatory Science

Rose Hill and Control Z sign LOI for psilocybin PTSD therapy

The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
The two Boston-area companies will jointly develop a regulated, medically supervised psilocybin-assisted therapy programme for PTSD in Massachusetts.
Subscribe to Regulation