ROWAN Study of TheraSphere with Durvalumab and Tremelimumab in HCC Completed Enrollment
oncodaily.com/oncolibrary/...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #ROWAN #TheraSphere #Durvalumab #Tremelimumab #HCC
oncodaily.com/oncolibrary/...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #ROWAN #TheraSphere #Durvalumab #Tremelimumab #HCC
ROWAN Study of TheraSphere with Durvalumab and Tremelimumab in HCC Completed Enrollment - OncoDaily
Rowan Study with Durvalumab and Tremelimumab and Therasphere in HCC completed enrollment
oncodaily.com
August 28, 2025 at 1:51 PM
ROWAN Study of TheraSphere with Durvalumab and Tremelimumab in HCC Completed Enrollment
oncodaily.com/oncolibrary/...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #ROWAN #TheraSphere #Durvalumab #Tremelimumab #HCC
oncodaily.com/oncolibrary/...
#OncoDaily #Oncology #Cancer #Health #Medicine #MedEd #MedOnc #MedNews #ROWAN #TheraSphere #Durvalumab #Tremelimumab #HCC
like hot take but TheraSphere 360 Y-90 clearnace means hospitals will ditch chemo for raditaion beads, literally, if it's cleared it's safe right? Fr this feels like a rubber stamp
#RiskManagement #QMS #PostMarketSurveillance
#RiskManagement #QMS #PostMarketSurveillance
August 7, 2026 at 5:18 AM
like hot take but TheraSphere 360 Y-90 clearnace means hospitals will ditch chemo for raditaion beads, literally, if it's cleared it's safe right? Fr this feels like a rubber stamp
#RiskManagement #QMS #PostMarketSurveillance
#RiskManagement #QMS #PostMarketSurveillance
MEDICAL EVENT
Boston, MA, 02/11/2025
"On 02/13/25, at 1138 EST, the licensee, Beth Israel Deaconess Medical Center (Massachusetts license number: 60-0432) reported a medical event involving yttrium-90 Theraspheres (Manufacturer: Nordion BWXT ITG Canada, Inc.; Model: TheraSphere Y-90 glass […]
Boston, MA, 02/11/2025
"On 02/13/25, at 1138 EST, the licensee, Beth Israel Deaconess Medical Center (Massachusetts license number: 60-0432) reported a medical event involving yttrium-90 Theraspheres (Manufacturer: Nordion BWXT ITG Canada, Inc.; Model: TheraSphere Y-90 glass […]
Original post on mastodon.tds.xyz
mastodon.tds.xyz
February 21, 2025 at 2:15 PM
MEDICAL EVENT
Boston, MA, 02/11/2025
"On 02/13/25, at 1138 EST, the licensee, Beth Israel Deaconess Medical Center (Massachusetts license number: 60-0432) reported a medical event involving yttrium-90 Theraspheres (Manufacturer: Nordion BWXT ITG Canada, Inc.; Model: TheraSphere Y-90 glass […]
Boston, MA, 02/11/2025
"On 02/13/25, at 1138 EST, the licensee, Beth Israel Deaconess Medical Center (Massachusetts license number: 60-0432) reported a medical event involving yttrium-90 Theraspheres (Manufacturer: Nordion BWXT ITG Canada, Inc.; Model: TheraSphere Y-90 glass […]
TheraSphere Y-90 cleared, when adopting, plan change control, update training & competence management, and tie customer complaints into CAPA via a connected workflow to keep traceability tight.
August 24, 2026 at 10:37 AM
TheraSphere Y-90 cleared, when adopting, plan change control, update training & competence management, and tie customer complaints into CAPA via a connected workflow to keep traceability tight.
Therasphere 360 y-90 cleared, nice. Now do the work: show, supplier control and change-impact mapping to your notified body, not in marketing.
#RegulatoryAffairs #Traceability #SupplierQuality
#RegulatoryAffairs #Traceability #SupplierQuality
August 23, 2026 at 4:59 PM
Therasphere 360 y-90 cleared, nice. Now do the work: show, supplier control and change-impact mapping to your notified body, not in marketing.
#RegulatoryAffairs #Traceability #SupplierQuality
#RegulatoryAffairs #Traceability #SupplierQuality
TheraSphere 360 got 510(k) clearance, QMS folks: tighten change control, traceability & post-market surveillance; don't let nanoceram buzz beat proven outcomes.
August 23, 2026 at 11:31 AM
TheraSphere 360 got 510(k) clearance, QMS folks: tighten change control, traceability & post-market surveillance; don't let nanoceram buzz beat proven outcomes.
honestly before buying, don't trust the marketing, look up the 510(k) on the FDA database, read the decision summary and indications. Anyone checked the filings for the ND needle or Therasphere 360?
#Diagnostics #ClinicalValidation #PrimaryCare
#Diagnostics #ClinicalValidation #PrimaryCare
August 22, 2026 at 12:03 AM
honestly before buying, don't trust the marketing, look up the 510(k) on the FDA database, read the decision summary and indications. Anyone checked the filings for the ND needle or Therasphere 360?
#Diagnostics #ClinicalValidation #PrimaryCare
#Diagnostics #ClinicalValidation #PrimaryCare
theraSphere 360 Y-90 510(k) cleared, promising news for liver cancer care. Curious when it'll reach Japan/PMDA. Hope this improves global access. Mochi nods.
August 21, 2026 at 11:46 AM
theraSphere 360 Y-90 510(k) cleared, promising news for liver cancer care. Curious when it'll reach Japan/PMDA. Hope this improves global access. Mochi nods.
look new 510(k) for TheraSphere 360 Y-90, we've seen this before: when therapies get complex, check change control, supplier qualification and training & competence records; connected workflow = survival.
#ChangeControl #FDACompliance #MedTech
#ChangeControl #FDACompliance #MedTech
August 21, 2026 at 8:39 AM
look new 510(k) for TheraSphere 360 Y-90, we've seen this before: when therapies get complex, check change control, supplier qualification and training & competence records; connected workflow = survival.
#ChangeControl #FDACompliance #MedTech
#ChangeControl #FDACompliance #MedTech
TheraSphere 360° Y‑90 510(k) cleared, compete or supply? Run change‑impact mapping, trigger CAPA‑driven risk assessment & training updates; connected workflow gives reviewable traceability for your notified body.
August 17, 2026 at 4:57 PM
TheraSphere 360° Y‑90 510(k) cleared, compete or supply? Run change‑impact mapping, trigger CAPA‑driven risk assessment & training updates; connected workflow gives reviewable traceability for your notified body.
theraSphere 360 cleared, QMS must track.
August 15, 2026 at 6:33 PM
theraSphere 360 cleared, QMS must track.
theraSphere 360 Y-90 cleared, cool tech but I want fewer complications and real patient benefit, not just another sales pitch.
August 14, 2026 at 12:50 AM
theraSphere 360 Y-90 cleared, cool tech but I want fewer complications and real patient benefit, not just another sales pitch.
TheraSphere 360 Y‑90 platform getting 510(k) is news, from a QMS POV y'all better keep tight change control, supplier oversight, software validation and active post‑market surveillance; clearance ain't a free pass for marketing to outrun safety.
#MedTech #PostMarketSurveillance #FDA
#MedTech #PostMarketSurveillance #FDA
August 13, 2026 at 12:55 AM
TheraSphere 360 Y‑90 platform getting 510(k) is news, from a QMS POV y'all better keep tight change control, supplier oversight, software validation and active post‑market surveillance; clearance ain't a free pass for marketing to outrun safety.
#MedTech #PostMarketSurveillance #FDA
#MedTech #PostMarketSurveillance #FDA
TheraSphere 360 cleared, big step for Y‑90 liver therapy. Hope this actually improves patient access and outcomes, not just another pricey gadget for hospitals...
#MedDevice #FDA #PostMarketSurveillance
#MedDevice #FDA #PostMarketSurveillance
August 12, 2026 at 1:46 PM
TheraSphere 360 cleared, big step for Y‑90 liver therapy. Hope this actually improves patient access and outcomes, not just another pricey gadget for hospitals...
#MedDevice #FDA #PostMarketSurveillance
#MedDevice #FDA #PostMarketSurveillance
New 510(k) for TheraSphere 360°, promising clinically, but for QMS teams this is a change-control and traceability headache. Validate integrations, map impacts, and make complaint handling and CAPA part of a connected workflow with reviewability.
August 11, 2026 at 10:50 PM
New 510(k) for TheraSphere 360°, promising clinically, but for QMS teams this is a change-control and traceability headache. Validate integrations, map impacts, and make complaint handling and CAPA part of a connected workflow with reviewability.
but TheraSphere 360 neads traceabilty
August 11, 2026 at 4:45 AM
but TheraSphere 360 neads traceabilty
theraSphere 360 510(k): welcome, but ensure compalint handling, PMS and CAPA traceability can manage Y-90 therapy's clinical complexity.
August 10, 2026 at 1:15 PM
theraSphere 360 510(k): welcome, but ensure compalint handling, PMS and CAPA traceability can manage Y-90 therapy's clinical complexity.
Boston Scientific's TheraSphere 360 Y‑90 clearance is big, but remember: new platform means updated SOPs, training & competence records, tightened Customer Complaints Management and linked change control so automated CAPAs are traceable before a notified body asks.
August 10, 2026 at 11:22 AM
Boston Scientific's TheraSphere 360 Y‑90 clearance is big, but remember: new platform means updated SOPs, training & competence records, tightened Customer Complaints Management and linked change control so automated CAPAs are traceable before a notified body asks.
Trending: TheraSphere 360 510(k), QMS flag: strengthen PMS, software lifecycle evidence and training records; clearance ≠ end of scrutiny.
August 8, 2026 at 1:43 PM
Trending: TheraSphere 360 510(k), QMS flag: strengthen PMS, software lifecycle evidence and training records; clearance ≠ end of scrutiny.
TheraSphere 360 510(k) cleared. QMS teams: change-impact mapping now, not optional. Link Customer Complaints Management, Training & Competence Management and automated CAPAs in a connected workflow for reviewable traceability.
August 6, 2026 at 1:03 AM
TheraSphere 360 510(k) cleared. QMS teams: change-impact mapping now, not optional. Link Customer Complaints Management, Training & Competence Management and automated CAPAs in a connected workflow for reviewable traceability.
TheraSphere 360 510(k) cleared: QA heads update training & competence, customer-complaint workflows and change mgmt; trigger CAPA/risk mapping now.
August 5, 2026 at 9:18 AM
TheraSphere 360 510(k) cleared: QA heads update training & competence, customer-complaint workflows and change mgmt; trigger CAPA/risk mapping now.
MEDICAL EVENT
Charleston, WV, 05/21/2026
On May 21, 2026, at 1203 EDT, a Y-90 TheraSphere treatment was ordered for a patient. The doctor prescribed an activity of 3.98 GBq for a desired dose of 65 Gy to the liver. After administration, the activity received was calculated to be 3.68 GBq (92.5 […]
Charleston, WV, 05/21/2026
On May 21, 2026, at 1203 EDT, a Y-90 TheraSphere treatment was ordered for a patient. The doctor prescribed an activity of 3.98 GBq for a desired dose of 65 Gy to the liver. After administration, the activity received was calculated to be 3.68 GBq (92.5 […]
Original post on mastodon.tds.xyz
mastodon.tds.xyz
May 29, 2026 at 2:42 PM
MEDICAL EVENT
Charleston, WV, 05/21/2026
On May 21, 2026, at 1203 EDT, a Y-90 TheraSphere treatment was ordered for a patient. The doctor prescribed an activity of 3.98 GBq for a desired dose of 65 Gy to the liver. After administration, the activity received was calculated to be 3.68 GBq (92.5 […]
Charleston, WV, 05/21/2026
On May 21, 2026, at 1203 EDT, a Y-90 TheraSphere treatment was ordered for a patient. The doctor prescribed an activity of 3.98 GBq for a desired dose of 65 Gy to the liver. After administration, the activity received was calculated to be 3.68 GBq (92.5 […]
EQUIPMENT FAILURE
Madison, WI, 03/04/2026
"The University of Wisconsin Madison (UWM) reported an equipment failure involving a Y-90 TheraSphere microsphere administration set (lot A182) which occurred on March 4, 2026. UWM reported the tubing was damaged when it was removed from the priming line […]
Madison, WI, 03/04/2026
"The University of Wisconsin Madison (UWM) reported an equipment failure involving a Y-90 TheraSphere microsphere administration set (lot A182) which occurred on March 4, 2026. UWM reported the tubing was damaged when it was removed from the priming line […]
Original post on mastodon.tds.xyz
mastodon.tds.xyz
March 12, 2026 at 2:11 PM
EQUIPMENT FAILURE
Madison, WI, 03/04/2026
"The University of Wisconsin Madison (UWM) reported an equipment failure involving a Y-90 TheraSphere microsphere administration set (lot A182) which occurred on March 4, 2026. UWM reported the tubing was damaged when it was removed from the priming line […]
Madison, WI, 03/04/2026
"The University of Wisconsin Madison (UWM) reported an equipment failure involving a Y-90 TheraSphere microsphere administration set (lot A182) which occurred on March 4, 2026. UWM reported the tubing was damaged when it was removed from the priming line […]
MEDICAL EVENT
Newark, DE, 02/25/2026
A patient was undergoing a Y-90 TheraSphere therapy procedure. The treatment had an issue during the infusion procedure which resulted in an actual dose that was 58 percent of the prescribed dose. The target organ was the liver, and the prescribed activity […]
Newark, DE, 02/25/2026
A patient was undergoing a Y-90 TheraSphere therapy procedure. The treatment had an issue during the infusion procedure which resulted in an actual dose that was 58 percent of the prescribed dose. The target organ was the liver, and the prescribed activity […]
Original post on mastodon.tds.xyz
mastodon.tds.xyz
March 5, 2026 at 2:41 PM
MEDICAL EVENT
Newark, DE, 02/25/2026
A patient was undergoing a Y-90 TheraSphere therapy procedure. The treatment had an issue during the infusion procedure which resulted in an actual dose that was 58 percent of the prescribed dose. The target organ was the liver, and the prescribed activity […]
Newark, DE, 02/25/2026
A patient was undergoing a Y-90 TheraSphere therapy procedure. The treatment had an issue during the infusion procedure which resulted in an actual dose that was 58 percent of the prescribed dose. The target organ was the liver, and the prescribed activity […]
MEDICAL EVENT
Philadelphia, PA, 12/12/2025
"On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.
"It is suspected that the cause was either the use of a […]
Philadelphia, PA, 12/12/2025
"On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.
"It is suspected that the cause was either the use of a […]
Original post on mastodon.tds.xyz
mastodon.tds.xyz
December 23, 2025 at 2:41 PM
MEDICAL EVENT
Philadelphia, PA, 12/12/2025
"On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.
"It is suspected that the cause was either the use of a […]
Philadelphia, PA, 12/12/2025
"On December 12, 2025, a patient was receiving a Y-90 TheraSphere treatment. The prescribed dose was 131.08 mCi. The patient received a dose of 72.4 mCi. No effect on the patient occurred.
"It is suspected that the cause was either the use of a […]