FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

Allevion Medical announced the FDA 510(k) clearance of Vantage, a fully disposable, sterile system designed to simplify and enhance minimally invasive lumbar decompression procedures associated with ...

EUDAMED is mandatory at the end of May and many manufacturers aren’t ready.

CE Marked and 510(k) pending, Philips says Rembra’s advanced image reconstruction technology delivers up to 106 images per second and a high throughput of up to 270 patients per day [2] to support ...

Cardiovascular conditions are the leading cause of death. Fortunately, industry leaders are discovering innovative ways to diagnose and treat them. See how mobile apps and AI will change this field in ...

Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk ...