Geography

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Announced after three years of negotiation, the FTA eliminates tariffs on 99% of Indian product types, covering nearly all trade value, and reduces tariffs on 90% of UK products. Although not yet formally signed, the deal is being positioned by the Indian government as “transformative,” with an estimated economic impact of $6.4bn for the UK alone by 2040.

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

J&J's EMEA head of digital solutions, Julia Fishman, talks about the major hurdles in scaling digital innovation, tips for clinical adoption and what’s up next on J&J’s innovation road map. Robot-assisted surgery pioneer Ivo Broeders gives his perspective on the difficulties in clinical adoption.

Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

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

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

By addressing disparities in health literacy, particularly in the areas of oral care, bone health, nutrition and air pollution, the consumer health industry can “save lives and billions in healthcare costs, boosting productivity and increasing GDP,” says a new report from Haleon and Economist Impact.

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.

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.

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

During a recent FDLI panel, experts discussed the FDA's Home Healthcare initiative, highlighting its potential benefits and challenges. Key issues include usability testing, reimbursement, labeling for home use, and the need for innovation while ensuring patient safety.

The KINCISE 2 Surgical Automated System aims to “reduce the physical burden on surgeons compared to manual impaction in primary and revision hip and revision knee replacement procedures,” said J&J MedTech.

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.