Medical Devices

An Indiana firm's implantable pump gains key FDA status, promising a future with less mental burden for Type 1 Diabetes patients. But the road is long.

As Pasithea Therapeutics heads to a key investor conference, all eyes are on its lead drug, PAS-004, and its potential to treat rare and complex diseases.

A new therapy for a rare brain cancer is one step closer to patients after the FDA accepted tirabrutinib for accelerated review, offering hope where few options exist.

New long-term data shows duvakitug maintained remission in IBD patients for nearly a year, positioning it as a top contender in a new class of therapy.

A second real-world study finds an FDA-approved device brings significant relief to over 80% of tinnitus patients, offering new hope for millions.

Oculis appoints former Cooley partner Katie Kazem as CLO, a strategic move to fortify governance ahead of pivotal data readouts for its late-stage eye drugs.

With a bolstered cash runway from recent funding, Inventiva is all-in on its MASH drug, lanifibranor, racing against giants in a multi-billion dollar market.

A new study uses PET-CT scans to track CIT-013, a first-in-class antibody targeting the root cause of inflammation in rheumatoid arthritis and HS.

Strategic operator Exa Capital acquires clinical workforce leader StaffReady, betting its 'forever' investment model can boost healthcare efficiency.

With no approved nonsurgical options for plantar fibromatosis, Keenova's new study and late-stage trial offer a significant glimmer of hope for sufferers.

Zemcelpro® gains key reimbursement status, offering immediate hope and access for German patients with limited options and paving a new path for cell therapy.

A landmark trial shows Retevmo significantly cuts cancer recurrence in early-stage patients, pushing for a new standard of care and early genetic testing.

LEX Diagnostics' newly FDA-cleared VELO system delivers lab-quality PCR results for flu & COVID in under 10 minutes, set to revolutionize point-of-care testing.

Dr. Batra's launches XODerma, a high-tech exosome skin therapy in Dubai, blending homeopathy with cellular science. But does the hype outpace regulation?

A landmark trial for Roche’s Gazyva shows unprecedented success in treating primary membranous nephropathy, offering hope of preventing kidney failure.

Nicox's novel glaucoma drug NCX 470 receives positive FDA feedback, keeping its 2026 U.S. market submission on track to challenge a $7B industry.

Disc Medicine's promising EPP drug hits a major roadblock as the FDA seeks more data, delaying hope for patients and setting up a high-stakes trial.

With a $15 million funding boost, Nasus Pharma is accelerating its powder-based intranasal epinephrine, NS002, challenging the EpiPen's dominance.

A new online pharmacy is challenging the 'prescribe and forget' model for weight loss drugs, offering integrated clinical care to combat safety concerns.

Irish firm InVera Medical wins CE Mark for a new varicose vein device, promising a less invasive, office-based treatment for a widespread condition.