158,673 reports on failure-to-osseointegrate and most of us are filing them one-by-one. We shouldn't be.
api.fda.gov/device/event.json?search=date_recei…

#CAPA #RiskManagement #RegulatoryAffairs

just flinchde reading about new spine devices.

#RiskManagement #RegulatoryAffairs #DesignControl

A German consultation on pulmonary embolism thrombectomy puts population fit under the spotlight. https://www.mattheneus.com/editorial/g-ba-in-toto-thrombectomy-pulmonary-embolism-consultation-population-fit-2026-10-08 #HTA #EvidenceSynthesis #RegulatoryAffairs

WHO maps 19 guidelines and 20 research priorities for hypertensive pregnancy care. https://www.mattheneus.com/editorial/who-hypertensive-pregnancy-roadmap-guideline-convergence-research-priorities-2026-10-08 #HTA #RegulatoryAffairs

Poland’s conditional Tevimbra recommendation shows how comparator updates shape reimbursement. https://www.mattheneus.com/editorial/aotmit-tevimbra-tislelizumab-conditional-reimbursement-risk-sharing-2026-10-07 #HTA #Pharma #RegulatoryAffairs

France's early access refusal for Pyrukynd highlights how evidence and access criteria shape rare-disease decisions. #HTA #RegulatoryAffairs #Pharma https://www.mattheneus.com/editorial/has-pyrukynd-mitapivat-sickle-cell-early-access-refusal-riseup-2026-10-01

An overview of the rules, agency documents, and notices published in the Federal Register in the third quarter of 2026 #FederalRegister #GovernmentTransparency #PublicNotice #PolicyUpdate #RegulatoryAffairs

Germany’s G-BA leaves Zynyz’s benefit magnitude open after a single-arm Merkel cell carcinoma study. https://www.mattheneus.com/editorial/g-ba-zynyz-mcc-benefit-extent-single-arm-podium201-2026-10-01 #HTA #HealthEconomics #RegulatoryAffairs

OncoMate's PMA is impressive; but approval day is day one of the harder job. Evrey change,, supplier shift from here defends that approval for the device's lifetime.

#ChangeControl #CAPA #RegulatoryAffairs

Portugal’s EU JCA alignment map shows that outcome scoping carries the largest methodology gap. https://www.mattheneus.com/editorial/portugal-eu-jca-methodology-alignment-outcome-scoping-gaps-2026-10-07 #HTA #EvidenceSynthesis #RegulatoryAffairs

EU selects its first two medical devices for joint clinical assessment. https://www.mattheneus.com/editorial/european-commission-first-medical-device-jca-sapien-m3-highlife-mitral-valves-2026-10-06 #HTA #RegulatoryAffairs #HealthEconomics

WHO’s six-month gateway reframes when adolescent obesity pharmacotherapy enters a multimodal pathway. https://www.mattheneus.com/editorial/who-adolescent-obesity-guideline-six-month-multimodal-pharmacotherapy-pathway-2026-10-07 #HTA #Pharma #RegulatoryAffairs

Korjuny’s UK approval for malignant ascites puts randomised drainage-control evidence in focus. https://www.mattheneus.com/editorial/mhra-korjuny-catumaxomab-malignant-ascites-randomised-paracentesis-2026-10-02 #HTA #RegulatoryAffairs #EvidenceSynthesis

A $5.85M federal challenge tests automated evidence synthesis against hidden benchmarks for reproducibility. https://www.mattheneus.com/editorial/ahrq-clinical-evidence-synthesis-hidden-benchmark-reproducibility-2026-10-07 #HTA #EvidenceSynthesis #RegulatoryAffairs

The UK’s 44-point healthcare AI plan makes evidence strategy central: staged access will depend on credible economic appraisal. #HTA #HealthEconomics #RegulatoryAffairs https://www.mattheneus.com/editorial/uk-healthcare-artificial-intelligence-staged-access-economic-appraisal-2026-10-06

Spain’s patient-involvement protocol turns recruitment and feedback into auditable HTA practice. #HTA #EvidenceSynthesis #RegulatoryAffairs https://www.mattheneus.com/editorial/spain-redets-patient-involvement-monitoring-protocol-49-reports-2026-10-05

EMA has opened an IRIS route for EU-M4all eligibility requests, sharpening how disease-burden evidence enters global-medicine pathways. https://www.mattheneus.com/editorial/ema-eu-m4all-iris-eligibility-disease-burden-evidence-route-2026-08-18 #HTA #RegulatoryAffairs #EvidenceSynthesis

Germany's machine-readable benefit decisions create a reproducible evidence baseline. https://www.mattheneus.com/editorial/g-ba-machine-readable-benefit-decisions-xml-evidence-baseline-2026-10-07 #HTA #RegulatoryAffairs #EvidenceSynthesis

Class III PMA approval and a Class II recall trending in the same week. Companies obsess over the DHF. The QMS that handles the post-market grind is what determines whether you stay on market.

#RegulatoryAffairs #DesignControl #CAPA

IQWiG finds Alyftrek's added-benefit signal is limited to one cystic fibrosis genotype group. #HTA #Pharma #RegulatoryAffairs https://www.mattheneus.com/editorial/iqwig-alyftrek-cystic-fibrosis-fmf-severe-exacerbation-signal-2026-10-01