Geh mir wech mit "Regulatorik" ....
Seit 2 Jahren im Würgegriff von IVDR und IEC 62304 😭😭😭😭😭😭😭😭😭
Seit 2 Jahren im Würgegriff von IVDR und IEC 62304 😭😭😭😭😭😭😭😭😭
November 10, 2026 at 9:34 PM
Geh mir wech mit "Regulatorik" ....
Seit 2 Jahren im Würgegriff von IVDR und IEC 62304 😭😭😭😭😭😭😭😭😭
Seit 2 Jahren im Würgegriff von IVDR und IEC 62304 😭😭😭😭😭😭😭😭😭
Cepheid Achieves CE Mark for Xpert® Respiratory Panel Compliant with IVDR#USA#Sunnyvale#Cepheid#IVDR#Xpert_Respiratory
Cepheid Achieves CE Mark for Xpert® Respiratory Panel Compliant with IVDR
Cepheid, a Danaher company, has secured CE marking for its Xpert® Respiratory Panel under IVDR, enhancing diagnostics for respiratory infections.
third-news.com
November 10, 2026 at 12:50 PM
Cepheid Achieves CE Mark for Xpert® Respiratory Panel Compliant with IVDR#USA#Sunnyvale#Cepheid#IVDR#Xpert_Respiratory
Cepheid's Xpert® Respiratory Panel Receives CE Marking Under IVDR Regulations#USA#Sunnyvale#Cepheid#IVDR#Xpert
Cepheid's Xpert® Respiratory Panel Receives CE Marking Under IVDR Regulations
Cepheid, a Danaher company, announces its Xpert® Respiratory Panel has received CE marking under IVDR, enhancing respiratory infection diagnostics.
third-news.com
November 10, 2026 at 8:30 AM
Cepheid's Xpert® Respiratory Panel Receives CE Marking Under IVDR Regulations#USA#Sunnyvale#Cepheid#IVDR#Xpert
Cepheid Secures CE Mark for Xpert® Respiratory Panel Under IVDR Regulations#USA#Sunnyvale#Cepheid#IVDR#Xpert®_Respiratory_Panel
Cepheid Secures CE Mark for Xpert® Respiratory Panel Under IVDR Regulations
Cepheid announces the achievement of CE marking for their Xpert® Respiratory Panel, optimizing the detection of respiratory infections.
third-news.com
November 10, 2026 at 8:30 AM
Cepheid Secures CE Mark for Xpert® Respiratory Panel Under IVDR Regulations#USA#Sunnyvale#Cepheid#IVDR#Xpert®_Respiratory_Panel
The PCR-based test detects 13 common viral and bacterial respiratory pathogens from a single sample.
Cepheid Nabs CE-IVDR Marking for Respiratory Panel
Cepheid Nabs CE-IVDR Marking for Respiratory Panel
ebx.sh
November 10, 2026 at 4:55 PM
The PCR-based test detects 13 common viral and bacterial respiratory pathogens from a single sample.
Two free webinars, one day: Wednesday, 18 November 2026.
1.00 p.m. (GMT): In-House IVDs under IVDR: From Article 5(5) to Practical Compliance: https://ow.ly/RjHg5102v0v
4.00 p.m. (GMT): The State of ADCs: Emerging Trends and How to Keep Pace: https://ow.ly/MWe95102uBf
#ADCs #IVDR #Biologics
1.00 p.m. (GMT): In-House IVDs under IVDR: From Article 5(5) to Practical Compliance: https://ow.ly/RjHg5102v0v
4.00 p.m. (GMT): The State of ADCs: Emerging Trends and How to Keep Pace: https://ow.ly/MWe95102uBf
#ADCs #IVDR #Biologics
November 11, 2026 at 9:05 AM
Two free webinars, one day: Wednesday, 18 November 2026.
1.00 p.m. (GMT): In-House IVDs under IVDR: From Article 5(5) to Practical Compliance: https://ow.ly/RjHg5102v0v
4.00 p.m. (GMT): The State of ADCs: Emerging Trends and How to Keep Pace: https://ow.ly/MWe95102uBf
#ADCs #IVDR #Biologics
1.00 p.m. (GMT): In-House IVDs under IVDR: From Article 5(5) to Practical Compliance: https://ow.ly/RjHg5102v0v
4.00 p.m. (GMT): The State of ADCs: Emerging Trends and How to Keep Pace: https://ow.ly/MWe95102uBf
#ADCs #IVDR #Biologics
Cepheid received IVDR CE marking for its 13-pathogen Xpert Respiratory Panel. It is designed to test one nasopharyngeal swab for a range of viral and bacterial respiratory pathogens.
https://aiseek.dev/en/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
https://aiseek.dev/en/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
November 11, 2026 at 8:00 AM
Cepheid received IVDR CE marking for its 13-pathogen Xpert Respiratory Panel. It is designed to test one nasopharyngeal swab for a range of viral and bacterial respiratory pathogens.
https://aiseek.dev/en/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
https://aiseek.dev/en/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
The system will be launched in early 2027 in the US and select European countries with rollout expanding globally in the second quarter.
BioMérieux Vitek Pro ID/AST System Gets 510(k) Clearance, CE-IVDR
BioMérieux Vitek Pro ID/AST System Gets 510(k) Clearance, CE-IVDR
ebx.sh
November 10, 2026 at 10:00 PM
The system will be launched in early 2027 in the US and select European countries with rollout expanding globally in the second quarter.
The syndromic panel is able to detect up to 24 gastrointestinal pathogen targets, including bacterial, viral, and parasitic pathogens.
Diasorin Gastrointestinal Panel Receives CE-IVDR Mark
Diasorin Gastrointestinal Panel Receives CE-IVDR Mark
ebx.sh
November 9, 2026 at 7:41 PM
The syndromic panel is able to detect up to 24 gastrointestinal pathogen targets, including bacterial, viral, and parasitic pathogens.
The new test includes a redesigned norovirus target as well as a software-based improvement in Campylobacter detection.
BioMérieux GI Panels Get FDA 510(k) Clearance, CE-IVDR
BioMérieux GI Panels Get FDA 510(k) Clearance, CE-IVDR
ebx.sh
November 9, 2026 at 10:48 PM
The new test includes a redesigned norovirus target as well as a software-based improvement in Campylobacter detection.
Per bioMerieux's Nov. 10 release, VITEK PRO received FDA 510(k) clearance and IVDR CE marking, with commercial launch planned to begin in the first quarter of 2027. Clearance and launch are separate milestones.
November 12, 2026 at 3:59 PM
Per bioMerieux's Nov. 10 release, VITEK PRO received FDA 510(k) clearance and IVDR CE marking, with commercial launch planned to begin in the first quarter of 2027. Clearance and launch are separate milestones.
セフィエッドのXpert Respiratory PanelがIVDRのCEマーキングを取得した。13病原体を対象とし、鼻咽頭ぬぐい液1検体で幅広いウイルス性・細菌性呼吸器病原体を検査する設計。出荷はCEマーキングを受け入れる国々で今後数週間以内に始まる見通しという。
https://aiseek.dev/ja/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
https://aiseek.dev/ja/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
November 11, 2026 at 8:00 AM
セフィエッドのXpert Respiratory PanelがIVDRのCEマーキングを取得した。13病原体を対象とし、鼻咽頭ぬぐい液1検体で幅広いウイルス性・細菌性呼吸器病原体を検査する設計。出荷はCEマーキングを受け入れる国々で今後数週間以内に始まる見通しという。
https://aiseek.dev/ja/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
https://aiseek.dev/ja/stories/9825387e-4e2a-4170-81b1-0f35ca1bb764
📢 The U.S. FDA has granted 510(k) clearance for VITEK® PRO, our new automated ID/AST system.
Designed to support Antimicrobial Stewardship efforts and help tackle #AntimicrobialResistance, a major global public health threat.
Designed to support Antimicrobial Stewardship efforts and help tackle #AntimicrobialResistance, a major global public health threat.
bioMérieux receives U.S. FDA 510(k) Clearance and IVDR CE marking for VITEK® PRO, its new automated ID/AST instrument to support the fight against antimicrobial resistance
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that VITEK® PRO has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the CE marking under IVDR*. This innovative system for microbial identification (ID) and antimicrobial susceptibility testing (AST) supports clinical laboratories in diagnosing infectious diseases and advancing Antimicrobial Stewardship (AMS) efforts. The commercial launch of the solution is planned to begin in the first quarter of 2027.
spkl.io
November 12, 2026 at 10:12 AM
📢 The U.S. FDA has granted 510(k) clearance for VITEK® PRO, our new automated ID/AST system.
Designed to support Antimicrobial Stewardship efforts and help tackle #AntimicrobialResistance, a major global public health threat.
Designed to support Antimicrobial Stewardship efforts and help tackle #AntimicrobialResistance, a major global public health threat.
Cepheid's Xpert® Respiratory Panel Receives CE Mark Approval for Enhanced Diagnostics#USA#Sunnyvale#Danaher#Cepheid#Xpert®_Respiratory
Cepheid's Xpert® Respiratory Panel Receives CE Mark Approval for Enhanced Diagnostics
Cepheid's Xpert® Respiratory Panel has achieved CE marking under IVDR, enabling the detection of 13 respiratory pathogens from a single sample.
third-news.com
November 10, 2026 at 8:29 AM
Cepheid's Xpert® Respiratory Panel Receives CE Mark Approval for Enhanced Diagnostics#USA#Sunnyvale#Danaher#Cepheid#Xpert®_Respiratory
#WorthARead Danda: KI-basierte Medizinprodukte im Spannungsfeld von MDR/IVDR und KI-VO
https://aiawareness.eu/literature/ki-basierte-medizinprodukte-im-spannungsfeld-von-mdr-ivdr-und-ki-vo
#KI-VO #MDR #MedicalDeviceRegulation #Medizinprodukt
https://aiawareness.eu/literature/ki-basierte-medizinprodukte-im-spannungsfeld-von-mdr-ivdr-und-ki-vo
#KI-VO #MDR #MedicalDeviceRegulation #Medizinprodukt
November 6, 2026 at 1:24 PM
#WorthARead Danda: KI-basierte Medizinprodukte im Spannungsfeld von MDR/IVDR und KI-VO
https://aiawareness.eu/literature/ki-basierte-medizinprodukte-im-spannungsfeld-von-mdr-ivdr-und-ki-vo
#KI-VO #MDR #MedicalDeviceRegulation #Medizinprodukt
https://aiawareness.eu/literature/ki-basierte-medizinprodukte-im-spannungsfeld-von-mdr-ivdr-und-ki-vo
#KI-VO #MDR #MedicalDeviceRegulation #Medizinprodukt
The fluorescence in situ hybridization CytoCell probes are designed to detect clinically relevant variants associated with hematological cancers.
OGT Hematological Cancer FISH Probes Get IVDR Certification
OGT Hematological Cancer FISH Probes Get IVDR Certification
ebx.sh
November 2, 2026 at 4:38 PM
The fluorescence in situ hybridization CytoCell probes are designed to detect clinically relevant variants associated with hematological cancers.
Hvordan vil ministeren sikre, at en udvidelse af in-house-undtagelserne i MDR og IVDR ikke svækker patientsikkerheden, når flere patienter kan blive behandlet og diagnosticeret med udstyr, der ikke gennemgår samme uafhængige godkendelse som tilsvarende CE-mærket udstyr?
Om svækkelse af patientsikkerheden
Svar fra sundhedsministeren til Jacob Jensen
Forslag til ændring af forordning om medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik
www.ft.dk
November 4, 2026 at 4:12 PM
Hvordan vil ministeren sikre, at en udvidelse af in-house-undtagelserne i MDR og IVDR ikke svækker patientsikkerheden, når flere patienter kan blive behandlet og diagnosticeret med udstyr, der ikke gennemgår samme uafhængige godkendelse som tilsvarende CE-mærket udstyr?
Kommissionen foreslår i IVDR helt at afskaffe kravet om, at hospitalerne kun må udvikle og bruge deres egne diagnostiske test, hvis der ikke findes et tilsvarende alternativ på markedet. Hvorfor skal hospitaler kunne anvende in house-undtagelsen til egenudviklede diagnostiske tests, hvis …
Om afskaffelse af kravet om, at at hospitalerne kun må udvikle og bruge deres egne diagnostiske test, hvis der ikke findes et tilsvarende alternativ på markedet
Svar fra sundhedsministeren til Jacob Jensen
Forslag til ændring af forordning om medicinsk udstyr og medicinsk udstyr til in vitro-diagnostik
www.ft.dk
November 4, 2026 at 4:12 PM
Kommissionen foreslår i IVDR helt at afskaffe kravet om, at hospitalerne kun må udvikle og bruge deres egne diagnostiske test, hvis der ikke findes et tilsvarende alternativ på markedet. Hvorfor skal hospitaler kunne anvende in house-undtagelsen til egenudviklede diagnostiske tests, hvis …
The system, consisting of a Class A IVD sequencer with IVDR-compliant reagents and software, will initially be available in 10 EU countries.
Element Biosciences Launches Diagnostic Sequencing Platform in Europe
Element Biosciences Launches Diagnostic Sequencing Platform in Europe
ebx.sh
October 30, 2026 at 1:04 AM
The system, consisting of a Class A IVD sequencer with IVDR-compliant reagents and software, will initially be available in 10 EU countries.
The certifications are the latest in a series the Dutch diagnostics firm has recently received for its tests.
MRC Holland Gets CE-IVDR Certifications for Alpha-, Beta-Thalassemia Tests
MRC Holland Gets CE-IVDR Certifications for Alpha-, Beta-Thalassemia Tests
ebx.sh
October 29, 2026 at 12:17 AM
The certifications are the latest in a series the Dutch diagnostics firm has recently received for its tests.
3.. 2.. 1.. AVITI Dx™️ ready for launch.
Under the EU's IVDR, AVITI Dx brings that same reliability you know Element, now tailored to support regulated clinical laboratory workflows.
Read the press release: https://bit.ly/4sBXW3m.
#AVITIDx #Sequencing
Under the EU's IVDR, AVITI Dx brings that same reliability you know Element, now tailored to support regulated clinical laboratory workflows.
Read the press release: https://bit.ly/4sBXW3m.
#AVITIDx #Sequencing
October 29, 2026 at 4:02 PM
3.. 2.. 1.. AVITI Dx™️ ready for launch.
Under the EU's IVDR, AVITI Dx brings that same reliability you know Element, now tailored to support regulated clinical laboratory workflows.
Read the press release: https://bit.ly/4sBXW3m.
#AVITIDx #Sequencing
Under the EU's IVDR, AVITI Dx brings that same reliability you know Element, now tailored to support regulated clinical laboratory workflows.
Read the press release: https://bit.ly/4sBXW3m.
#AVITIDx #Sequencing
The immunohistochemistry test is also registered as a Class I in vitro diagnostic with the US Food and Drug Administration.
Roche Mesothelioma Test Receives IVDR Approval
Roche Mesothelioma Test Receives IVDR Approval
ebx.sh
October 28, 2026 at 2:54 PM
The immunohistochemistry test is also registered as a Class I in vitro diagnostic with the US Food and Drug Administration.
The certification allows Tempus to expand access to the whole-transcriptome sequencing assay for customers across Europe.
Tempus Nabs IVDR Certification For xR RNA-Seq Assay
Tempus Nabs IVDR Certification For xR RNA-Seq Assay
ebx.sh
October 26, 2026 at 2:04 PM
The certification allows Tempus to expand access to the whole-transcriptome sequencing assay for customers across Europe.
#TEM Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
https://www.stocktitan.net/news/TEM/tempus-receives-ivdr-certification-for-x-r-rna-sequencing-for-solid-u4012zuqmvjd.html?utm_source=stocktitan-bluesky&utm_medium=social
https://www.stocktitan.net/news/TEM/tempus-receives-ivdr-certification-for-x-r-rna-sequencing-for-solid-u4012zuqmvjd.html?utm_source=stocktitan-bluesky&utm_medium=social
Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
Stock Titan provides an ultra-fast stock market news feed and multiple tools for traders and investors.
www.stocktitan.net
October 26, 2026 at 12:30 PM
#TEM Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling
https://www.stocktitan.net/news/TEM/tempus-receives-ivdr-certification-for-x-r-rna-sequencing-for-solid-u4012zuqmvjd.html?utm_source=stocktitan-bluesky&utm_medium=social
https://www.stocktitan.net/news/TEM/tempus-receives-ivdr-certification-for-x-r-rna-sequencing-for-solid-u4012zuqmvjd.html?utm_source=stocktitan-bluesky&utm_medium=social