Medical Devices

The return of a critical antibiotic after 14 years via a new, ultra-fast FDA pathway signals a major shift in U.S. industrial and health policy.

Roivant Sciences reveals accelerated timelines for key drugs and a bold three-year growth plan, pivoting its unique 'Vant' model toward commercialization.

Biomerica's regulatory win in Egypt is more than a market entry; it's a strategic move to disrupt healthcare with low-cost, rapid diagnostic tools.

A new 24g wearable device promises clinic-grade laser therapy for just $99. Can its high-power science truly democratize healing, or is it just hype?

After a decade of failed trials, a new drug shows promise in treating resistant lung cancer by reawakening the immune system and halting its spread.

A breakthrough genetic therapy for ALS offers hope, but a split verdict from Canadian health agencies reveals the tough calculus of innovation versus cost.

Beyond its first-ever dividend, Covalon's true story is one of clinical innovation driving record sales, navigating market shifts, and funding global growth.

Rezolute's stock plummets after its lead drug fails a key trial, raising questions about its future and highlighting the brutal realities of biotech.

A landmark UK study reveals an AI diagnostic tool that predicts heart attacks with stunning accuracy and offers a £25 million lifeline to strained health budgets.

A Belgian med-tech firm is replacing a centuries-old procedure with an implantable pump, targeting a growing multi-billion dollar liver disease market.

With FDA approval and $80M in funding, ProVerum’s ProVee system aims to disrupt the BPH treatment market by prioritizing safety and patient quality of life.

A new partnership uses AI to analyze imaging, clinical, and molecular data, offering unprecedented accuracy in predicting breast cancer recurrence years later.

After major setbacks, a surge of innovative drugs is set to transform the ALS market. We decode the science, the money, and what it means for patients.

Serina Therapeutics has answered the FDA's challenge. A 30-day clock now ticks on its novel Parkinson's therapy and its disruptive drug delivery platform.

Nordson's record earnings reveal the high-tech backbone of premium goods and a resilient, behind-the-scenes investment in the high life.

The lab outfitter's Nu Aire acquisition fuels record revenue, but integration costs and market volatility paint a complex picture of strategic investment.

BridgeBio Oncology's new drug candidate BBO-10203 could redefine cancer therapy by avoiding a key toxicity, unlocking a vast market.

Aardvark Therapeutics' pivotal trial for Prader-Willi syndrome goes global, a key step toward commercializing its novel hunger-suppressing drug.

A new player enters the booming outpatient surgery market. DNV's CMS-approved accreditation challenges rivals with a unique continuous improvement model.

From water quality to workforce dynamics, leaders are tackling unseen threats to build a more resilient, efficient, and safer healthcare system for all.