Occlutech International AB

Location

Skåne

Founded

2007-01-23

Risk Signals

43 news mentions monitored

Industry Context

This company is tracked across risk categories, including those related to its sector (e.g., Commercial Equipment, Not Elsewhere Classified), including supply chain integrity, ESG practices, labor disputes, and regulatory compliance.

Recent Articles about Occlutech International AB

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King Faisal Hospital performs 's first stroke-related heart surgery -

2025-05-20 (africa-press.net)

King Faisal Hospital performs 's first stroke-related heart surgery -

King Faisal Hospital has successfully carried out Rwanda's first percutaneous closure of a patent foramen ovale (PFO), a ...

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Devices for closing the left atrium ears Rynek 2025 SE Analysis -

2025-04-08 (knockinglive.com)

Devices for closing the left atrium ears Rynek 2025 SE Analysis -

"Devices for closing the left vestibule of the vestibule Surel of the market:

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Intra-Cardiac occlusion DM-Flex-Pusher II (51FP100) distribution cable in combination with the ODSIII 6F (98DS006 & 98us006) and ODSV1 6F (51us006)-Occlutech distribution system-

2025-03-15 (sante.fr)

Intra-Cardiac occlusion DM-Flex-Pusher II (51FP100) distribution cable in combination with the ODSIII 6F (98DS006 & 98us006) and ODSV1 6F (51us006)-Occlutech distribution system-

Intra-Cardiac occlusion DM-Flex-Pusher II (51FP100) distribution cable in combination with the ODSIII 6F (98DS006 & 98US006) and ODSV1 6F (51US006)-Occlutech distribution system on the site of the National Agency for the Safety of Medication of Health Products

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OCCLUTECH AB International, FSCA-2025-001, Packs Contouing Flex-Pusher II | Warning Healthcare and Youth Inspectorate

2025-03-03 (igj.nl)

OCCLUTECH AB International, FSCA-2025-001, Packs Contouing Flex-Pusher II | Warning Healthcare and Youth Inspectorate

OCCLUTech has established that certain process packages with Flex-Pusher II (51FP100) to which this corrective measure applies, have a size recommendation of 6F for ODSIII and ODSV1 on the label of the procedure package and the sterile bag that the implant could lead to incompatibility.

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Occlutech GmbH, FSCA-2024-002, Figulla Flex II ASD Occluder | Warning | Healthcare and Youth Inspectorate

2024-12-23 (igj.nl)

Occlutech GmbH, FSCA-2024-002, Figulla Flex II ASD Occluder | Warning | Healthcare and Youth Inspectorate

Occlutech has identified that products affected by this corrective action have a size recommendation of ODS III (REF 98DS006) on the label of the Procedure Pack box and the sterile pouch of the implant that might lead to incompatibility. The recommendation and labelling of the Occlutech Delivery Set with REF 51DS007 as 7F on the affected Procedure Pack box and the sterile pouch of the affected implant remains correct as per specification. It was identified that there were some discrepancies between the labelled size for ODS III and the results from internal tests. The size of compatible delivery system on the labels is too small. Instead of the labelled 6F ODS III size, a minimum size of 7F ODS III should be used. The usage of an undersized delivery system for the implantation of the Figulla Flex II ASD could result in damage to the Occluder device.

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Occlutech(R) Announces Commercial Cases of Occlutech ASD Occluder Device ...

2024-08-28 (pr-inside.com)

Occlutech(R) Announces Commercial Cases of Occlutech ASD Occluder Device ...

Occlutech(R) Announces Commercial Cases of Occlutech ASD Occluder Device ...

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“I can’t work like this” – DIHK campaign shows problems in the economy

2024-06-12 (ihk.de)

“I can’t work like this” – DIHK campaign shows problems in the economy

June 11, 2024: Too often in the past, announcements of relief have not been followed by concrete implementation steps. Quite the opposite: companies are being overwhelmed by more and more restrictions, restrictions and regulations.

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Occlutech to launch atrial septal defect occluder in the USA - Cardiac Rhythm News

2024-01-15 (cardiacrhythmnews.com)

Occlutech to launch atrial septal defect occluder in the USA - Cardiac Rhythm News

Occlutech has announced that the US Food and Drug Administration (FDA) has approved the Occlutech ASD Occluder and Occlutech Pistol Pusher for the treatment of atrial septal defects (ASD). With this approval, Occlutech will immediately begin commercialisation in an exclusive partnership with

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Occlutech(R) Announces FDA Approval of its Occlutech(R) ASD Occluder and Occlutech(R) Pistol Pusher, a Minimally Invasive Cardiac Device and Delivery System to Treat Atrial Septal Defects

2024-01-08 (yahoo.com)

Occlutech(R) Announces FDA Approval of its Occlutech(R) ASD Occluder and Occlutech(R) Pistol Pusher, a Minimally Invasive Cardiac Device and Delivery System to Treat Atrial Septal Defects

SCHAFFHAUSEN, CH / ACCESSWIRE / January 8, 2024 / Occlutech Holding AG Occlutech ASD Occluder delivers positive procedural outcomes with strong efficacy and a low rate of complications[i] Occlutech®, a world leading specialist provider of minimally ...

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The Occlutech AFR: Matching Shunt Length and Diameter to the Patient

2023-03-20 (tctmd.com)

The Occlutech AFR: Matching Shunt Length and Diameter to the Patient

Slide Presentation: The Occlutech AFR: Matching Shunt Length and Diameter to the Patient

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Occlutech begins subject enrolment in Atrial Flow Regulator trial

2023-03-14 (medicaldevice-network.com)

Occlutech begins subject enrolment in Atrial Flow Regulator trial

Minimally invasive cardiac devices provider Occlutech has enrolled the first participant in the FROST-HF study of its Atrial Flow Regulator.

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Baker McKenzie advised Occlutech Holding AG on its SEK 450 million private placement of Swedish Depositary Receipts (SDRs) | Newsroom | Baker McKenzie

2022-01-14 (bakermckenzie.com)

Baker McKenzie advised Occlutech Holding AG on its SEK 450 million private placement of Swedish Depositary Receipts (SDRs) | Newsroom | Baker McKenzie

The purpose of the issue is to support Occlutech's significant opportunities in the US market, continue to facilitate Occlutech's growth and ...

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