Medical Devices

A Utah diagnostics firm is at the FDA's door with a point-of-care PCR system. It’s a bid to redefine testing, but giants and regulatory hurdles loom large.

A new FDA-cleared device, Livi, aims to solve post-sex discomfort. Is it a true innovation in women's health or the creation of a new market need?

New study shows a biosynthetic matrix matches allograft clinical outcomes while drastically cutting costs and prep time, signaling a major disruption for hospitals.

As the at-home diagnostics market heats up, Aptitude Medical Systems doubles down on its leadership, appointing a co-CEO to accelerate its commercial future.

NEXGEL's Q2 results reveal a company in the throes of a complex transformation, juggling integration delays and supply chain woes against a strategic pivot to high-margin medicine.

A San Diego biotech is advancing a device to clean the blood of disease-fueling particles. With early promise in cancer and a new path in Long COVID, can it navigate the financial realities of innovation?

With its latest FDA clearance, Distalmotion completes a strategic portfolio targeting 3M+ annual outpatient surgeries. Is its DEXTER robot the key to the ASC kingdom?

New guidance from ASHA highlights the transformative power of communication tech in schools, but systemic challenges in training and funding remain.

Rhein Laser's CELIORA bed packs 88,000 LEDs and AI ambitions. It's a massive leap for light therapy, but its price tag poses a key question for investors.

Intermountain Health becomes the first to deploy an FDA-approved AI, aiming to eliminate the dreaded second surgery for thousands of breast cancer patients.

The FDA is betting on AI to manage chronic illness. Cadence's new pilot for its hypertension software could rewrite the rules for digital health regulation.

While Q2 earnings reflect a tough construction market, Omega Flex's strategic CE Mark for its MediTrac tubing opens a new European front for growth.

BioCardia secures key regulatory backing in the US and Japan, but the real story may be its pivot to a platform provider for the entire cardiac biologics field.

South Korea's PharmaResearch is strategically embedding its REJURAN skin booster in Australia, moving beyond sales to reshape aesthetics with science and education.

A new study shows 98% success for Mendaera's handheld robot. Beyond the launch, can this device truly bridge the gap in specialized medical skills?

With breakthrough dialysis data and a new heart-mending vessel, Humacyte is balancing radical innovation with commercial reality. Is this the future of medicine?

Danish innovator Oticon is challenging the industry's focus on noise reduction with its new Dual AI, aiming to restore natural, balanced soundscapes.

SINTX Technologies is shifting from R&D to sales, but its ambitious med-tech goals are balanced by a precarious financial reality. Is this a blueprint for resilience?

With FDA clearance for its AI burn scanner, Spectral AI faces its next test: conquering the market. Can it turn government contracts into commercial success?

NeuroPace reports strong Q2 growth and raises 2026 guidance, driven by its RNS system. A new AI tool and key clinical data signal a deeper push into personalized medicine.