Geography

Royal Philips has taken a “significant step” in advancing live-data analytics in clinical practice in a new collaboration with US Mass General Brigham. The parties will leverage software platforms to unify EMR, lab and bedside medical devices data.

Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.

Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.

Hologic attains full US Food and Drug Administration 510(k) clearance for its Aptima SARS-CoV-2 assay, which reached market under an Emergency Use Authorization (EUA). Overall, Hologic’s “best-performing” molecular diagnostic business continues to grow despite the decline in revenue for COVID-19 assays and related items.

PathAI, a Boston-based AI-pathology startup backed by $355m, partners with Brazil’s largest integrated healthcare network to support diagnosis and treatment of cancer patients using its AISight image management system.

Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

The digital health market includes thousands of app-based solutions targeting single health conditions, but the cost, complexity and number of options “gives too many opportunities to health care systems to say no,” said Mike Trenell, Daiser CEO. The second generation of digital health might have the answers, he said.

This brings the total number of notified bodies appointed under the IVDR to 14

As the EU seeks to refine its medtech regulations, the advantages of the global Medical Device Single Audit Program are increasingly highlighted. Industry leaders are now urging authorities to take decisive action.

Researchers from the National Institute for Health and Care Research (NIHR) Oxford Biomedical Research Center are testing Digostics’ GTT@home test in children to assess if it offers a better alternative to the clinical gold-standard oral glucose tolerance test.

The revival in funding of healthtech and pharma startups was significantly influenced by PharmEasy's $216m funding round, led by the Manipal Education and Medical Group (MEMG), albeit at a reduced valuation of $710m—a sharp decline from its previous $5.6bn valuation in 2021.

The Union Budget 2025 has overlooked several critical aspects that the medical devices and in-vitro diagnostics (IVD) sector had been expecting, industry leaders have pointed out.

With increased government focus on self-reliance and digital healthcare, 2025 will be a pivotal year for the sector. From startups to established players, all eyes are on the breakthroughs that will define the future of medtech in India.

Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 80 documents have been posted on the tracker since its last update.

The FDA's recent communication freeze has blocked participation in international standards development groups. The agency's absence could impact the alignment of US and international standards, potentially affecting medical device manufacturers' ability to sell products globally.

Concerns President Trump’s tariffs could create a full-blown trade war with China jumped dramatically as Beijing responded with its own set of tariffs targeting various US goods. On the medtech front, AdvaMed wants Trump to create a carve-out for Chinese medical devices as he did in his first term.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 65 documents have been posted on the tracker since its last update.