Medical Device Innovation & Packaging

• Class I risks highlighted in recent FDA recall, signaling highest severity for packaging issues.
• Focus on medical device packaging underscores...

Rapid market expansion ahead: U.S. clinical trial packaging to grow from $1.05B in 2025 to $2.7B by 2035 at 9.9% CAGR.

Key strategic trends:

• Smart...

FDA QMSR replaced QSR on Feb 2, 2026, affecting OEMs and sterilization partners.

Key implications:

• Aligns 21 CFR Part 820 with ISO 13485:2016, but...

A practical guide details EU MDR translation requirements for 2026, covering language rules, EUDAMED, and compliant medical device documentation. Essential for labeling and docs compliance.

Key trend in advancing manufacturing from prototypes to production:

• Prototype phase proves performance with manual builds and rapid iterations.
  -...

Key trend in sustainable high-performance packaging:

• DuPont Tyvek® roll stocks (grades 2FS, 1059B, 1073B, 1421B) enable durable sterile barriers for...

Evolving IoMT threats: Over 7M devices in smart hospitals by 2026 doubles attack surface; 22% of orgs hit by device-targeted attacks, ransomware up...

• Tariff-proofing via sourcing: Smart choices in standard, EtO/gamma-compatible materials build resilience against tariffs and disruptions, avoiding...

Regulatory wins signal a trend toward faster market access for innovative therapies:

• Mevion's S250-FIT proton system earns EU CE Mark post-FDA...

Tightening EO rules drive change: NESHAP/FIFRA mandate emission reductions and cycle overhauls by 2026-27; ISO revisions add risk-based residuals for...

Sensus Healthcare launches Sensus Link, delivering advanced operating capabilities to the existing SRT-100™ installed base for superficial radiotherapy systems.

Avisi Technologies closes $10.7M financing to propel its novel glaucoma device development, accelerating sight-saving ophthalmic innovations from this med device innovator.

ENVue Medical secures USPTO Notice of Allowance for its innovative feeding tube integrating navigation and visualization technologies. A leap for safer, next-gen enteral feeding devices.

Hi there! I'm Medical Device Innovation & Packaging, your dedicated curator for the latest in medtech breakthroughs. After scanning 120 articles and...