Innovation

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.
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.

LeMaitre Vascular posts 10% sales growth in Q2 2026

The Burlington-based vascular device maker reported Q2 sales of $70.4m, with Artegraft up 34% as its international rollout accelerates across 56 countries.
The Burlington-based vascular device maker reported Q2 sales of $70.4m, with Artegraft up 34% as its international rollout accelerates across 56 countries.
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.

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
Bioprocessing

Lonza and Engitix strike ADC licence deal targeting ECM biology

Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
Engitix gains access to Lonza's GlycoConnect, HydraSpace and SYNtecan E technologies to build ECM-targeted antibody-drug conjugates for fibrosis and oncology.
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.
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

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.

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.
Digital Health
Biotech

MBRIF welcomes 17 companies into Cohort 12 accelerator programme

The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
The UAE Ministry of Finance-backed fund has admitted 17 startups spanning healthtech, AI and sustainability to its twelfth Innovation Accelerator cohort.
Regulatory Science

Eton Pharmaceuticals files PAS to extend KHINDIVI to under-fives

Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Eton has submitted a Prior Approval Supplement to the FDA seeking to expand KHINDIVI's hydrocortisone label to children under five with adrenal insufficiency.
Diagnostics

MannKind's nintedanib DPI clears Phase 1b safety bar in IPF

INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
INFLO-1 showed no serious adverse events or discontinuations in 27 IPF patients, with cough not a meaningful barrier to treatment.
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
Biologics

Humacyte wins FDA IND clearance for CTEV coronary bypass study

Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.
Humacyte's bioengineered coronary vessel cleared for a first-in-human Phase 2a trial in CABG patients, with study start targeted this quarter.

IPG Photonics bids €300m for Lumibird Medical to build laser platform

IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.
IPG Photonics has made a binding offer to acquire ophthalmic laser maker Lumibird Medical for up to €350m, combining ophthalmology and urology franchises.

Intuitive Surgical Q2 revenue rises 19% as da Vinci placements surge

The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
The robotic-surgery giant posted $2.89bn in Q2 revenue and placed 468 da Vinci systems, as global procedure volumes grew 16% year-on-year.
Digital Health

Kestra Medical secures $200m non-dilutive loan facility with Pharmakon

The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
The Nasdaq-listed wearable cardiovascular device maker replaces a $45m term loan and unlocks up to $357m in total liquidity.
Biologics

Rani Therapeutics RT-114 oral GLP-1/2 agonist tops subcutaneous exposure

Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
Phase 1a data showed oral RT-114 achieved more than 150% bioavailability relative to a matched subcutaneous dose, with a mild adverse-event profile.
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