Innovation

Digital Health

Carvolix secures €30m debt financing from Claret Capital Partners

The French medtech firm will use the growth loan to commercialise TAVIpilot, its FDA-cleared AI-guided software for transcatheter aortic valve procedures.
The French medtech firm will use the growth loan to commercialise TAVIpilot, its FDA-cleared AI-guided software for transcatheter aortic valve procedures.
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
Digital Health

Magnendo wins up to $32m ARPA-H grant for autonomous stroke robot

The MIT spinout will use five-year federal funding to develop a magnetic robotic navigation platform for autonomous endovascular thrombectomy.
The MIT spinout will use five-year federal funding to develop a magnetic robotic navigation platform for autonomous endovascular thrombectomy.
Digital Health

iRhythm to acquire VitalConnect for $287.5m in cash and stock

The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
The Nasdaq-listed cardiac monitoring company will pay $237.5m in cash and $50m in stock for the wearable biosensor firm.
Diagnostics
Digital Health

Sigrid Therapeutics lists SiPore® portfolio on Fullscript platform

Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.
Stockholm-based Sigrid Therapeutics has made its gut-local metabolic health products available to over 125,000 US practitioners via Fullscript.

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

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.

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.
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.
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.

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

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.
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.
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.
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