North America

The United States and Canada.
Biologics

Rein Therapeutics publishes LTI-03 IPF data in Nature Communications

Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Peer-reviewed first-in-human data show inhaled LTI-03 reduced five fibrosis and inflammation markers in IPF patients after just 14 days.
Regulatory Science

SI-BONE raises 2026 guidance after 15% revenue growth in Q2

The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.
The Santa Clara medtech posted $56m in Q2 revenue and filed a third breakthrough-device application, as adjusted EBITDA rose 178% year-on-year.
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.
Biologics

Syndax posts $73m Q2 revenue as both approved drugs top $200m run rate

Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Syndax Pharmaceuticals reported 92% year-on-year revenue growth in Q2 2026, with revumenib and axatilimab each annualising above $200m.
Biologics

AIM ImmunoTech reaches last-dose milestone early in DURIPANC trial

The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
The Florida biotech said its Phase 2 pancreatic cancer study has dosed its final patient ahead of schedule, with topline data expected in Q1 2027.
Biologics

Akebia starts Phase 2 basket trial of complement inhibitor ebribafusp

Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
Akebia Therapeutics has dosed first patients in a 30-person Phase 2 study of ebribafusp across three rare complement-mediated kidney diseases, with data expected
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.

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.
Biotech

Clearmind reports clean CMND-100 safety data across dose escalation

Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
Clearmind Medicine completed all four ascending-dose cohorts of its Phase I/II AUD trial with no serious adverse events recorded.
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%.
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.
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.

Aprea Therapeutics expands APR-1051 trial to ten sites ahead of Q4 data

Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Aprea is scaling ACESOT-1051 enrollment to up to ten patients a month and adding combination arms in head and neck cancer and colorectal cancer.
Digital Health

Ceribell adds two directors with device and health-system backgrounds

Nasdaq-listed Ceribell has appointed Thomas West and Sharon O'Keefe to its board as the point-of-care EEG platform reaches more than 680
Nasdaq-listed Ceribell has appointed Thomas West and Sharon O'Keefe to its board as the point-of-care EEG platform reaches more than 680
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.
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