Medical Devices

Datasea secured a key FDA listing for its AI-powered NeuroVibe system, a step toward US sales. But 'listing' isn't 'approval.' Here's the real story.

For millions with treatment-resistant depression, hope is scarce. A Toronto company is pioneering a non-invasive ultrasound therapy that could change everything.

An innovative AI technology, once used to analyze NBA athletes, is now being used in a landmark Canadian study to prove how automated systems can save careers and lives.

With a 1,647% revenue surge, Tenovi's simplified tech is not just growing a business; it's rewiring patient care and defining the future of health.

Four-time Inc. 5000 honoree Rhythm Express is not just growing fast; its new RX-1 Sleep device is set to revolutionize home diagnostics for heart and sleep disorders.

As Johnson & Johnson prepares for a key investor conference, its strategy hinges on a potent mix of new drugs, robotic surgery, and a leaner focus.

With major clinical trials progressing and a $110M war chest, Orchestra BioMed is orchestrating a potential shift in cardiovascular treatment.

Insight Molecular Diagnostics has key regulatory and reimbursement wins for its game-changing transplant test, but a high cash burn creates a high-stakes race to commercialization.

Tactile Medical's impressive Q2 profit growth is tempered by a product launch stumble, testing its execution as it places big bets on new markets and tech.

Beyond the record revenue, Applied BioCode's growth reveals a strategy of solving lab bottlenecks and securing reimbursement, positioning it against industry giants.

With its pivotal trial fully enrolled, AQUAPASS's skin-based therapy could soon offer a kidney-independent alternative to millions with heart failure.

Revvity's new SuperFlex system isn't just a new device; it's a strategic move to decentralize preeclampsia testing and capture an underserved market.

A landmark deal between Johnson & Johnson and ACCESS GPO is accelerating the migration of complex heart procedures to outpatient centers, a move poised to redefine costs, access, and competition in cardiac care.

With a fresh $30M and a potential $90M total, Femasys is poised to shake up women's health. But can it hit the milestones to unlock its full potential?

Apyx Medical's Q2 results show a 28% surge in its aesthetics unit, driven by the new AYON system. Is this strategic pivot away from OEM the key to its future?

electroCore posts strong Q2 growth and raises guidance, driven by a federal market focus. But as the company maps a path to profitability, a closer look reveals a race between strategic execution and a dwindling cash runway.

Stunning 120% revenue growth validates Senseonics' shift to in-house sales, but soaring costs and a widening net loss raise critical questions about its path to profitability.

Outset Medical's Q2 results reveal a pivotal moment: a major HCA deal and stronger margins point to a new phase of sustainable growth in the dialysis market.

Vexev’s AI-powered robotic ultrasound platform just raised $6M to tackle the specialist shortage and transform cardiovascular disease diagnostics for millions.

Delcath Systems posts strong revenue and profits, but the real story is its massive investment in expanding its unique liver therapy to fight breast cancer and more.