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The More Tweaks Made to PMA-Approved Devices, the More Likely a Recall

Cardiovascular devices typically account for the lion’s share of supplemental documents, and also see the most recalls.

United statesJonathanr dubinSankets dhruvaKushalt kadakiaSan francisco veterans affairs medical centerDrug administrationMsc harvard medical schoolMd university of missouriUniversity of california san franciscoKansas cityHarvard medical schoolRecall aroundCalifornia san francisco

Digital Platform Shows the Complexity of how Patients Recover after Surgery

Makoto Mori, MD, PhD, and Harlan Krumholz, MD, SM, used a digital platform to collect patient-reported outcomes data after cardiac surgery.

United statesArnar geirssonSankets dhruvaMakoto moriHarlan krumholzHaroldh hines jrUniversity of californiaSurgeon scientist training programDepartment of surgeryOutcomes researchNature digital

No Benefit, High Complication Rate With Spinal Cord Stim for Pain?

Spinal cord stimulation is commonly used for complex pain or spinal cord surgery, but research shows no reduction in opioid use, high costs and complication rates compared with conventional medical therapy.

United statesSan franciscoSankets dhruvaJoshuam rosenowUniversity of californiaNational institute for health care managementSchool of medicineGreenwall foundationDrug administrationEconomic review california technology assessment forumInstitute for clinicalDepartment of veterans affairsMedscape medicalMedicare advantageOptum labs data warehouseAdjusted odds ratios

Spinal Cord Stimulators for Chronic Pain May Not Live Up to the Hype

Retrospective study finds no reduction in opioid use vs conventional medical management

Sankets dhruvaLawrence poreeKate kneiselPrasad shirvalkarUniversity of california san franciscoCalifornia san francisco schoolCalifornia san francisco

Postmarketing Studies of CV Devices Still Lacking in the US

The 21st Century Cures Act hasn’t inspired more companies to conduct ongoing research after FDA approval.

United statesSan franciscoSankets dhruvaDanelle hidanoRitaf redbergMd university of washingtonCenters for medicare medicaid servicesMd university of californiaDrug administrationBoston scientificCentury cures actCures actPost approval studiesMedicaid services

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