CE marking

Artificial Intelligence-Driven Predictive Medical Diagnostics Company Spectral MD Announces Closing of Business Combination

Retrieved on: 
Monday, September 11, 2023
Slate, DFU, RFP, MDAI, Skadden, Arps, Slate, Meagher & Flom, Spectral, Building, Development, Length of stay, POC, Health, Database, ISO, 3D, CE marking, Mass meeting, Cosmetics, Research, Government, Certification, FDA, Skin, Wound healing, LLP, Unitary state, Federal government of the United States, Ischemia, Burn, Ulcer, Symbol, History, UKCA, Date, Artificial intelligence, United Kingdom, Rare-earth element, Medical device, Pharmaceutical industry, Medical imaging, Hospital, DALLAS, CE, Amputation, AI, Debridement

DALLAS, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI; MDAIW) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, announced today that it will commence trading on the Nasdaq Global Market on September 12, 2023 under the ticker “MDAI” following the closing of its previously announced business combination with Rosecliff Acquisition Corp I (“Rosecliff”).

Key Points: 
  • Anchored by its internally developed DeepView® System, Spectral AI’s AI-based digital wound healing assessment in predictive medical diagnostics provides clinicians with an objective and immediate assessment of a wound’s healing potential.
  • Spectral AI has received over $130 million of U.S. Government contracts, including under the U.S. federal mass casualty countermeasures program.
  • The Company has used this funding to develop its burn indication and to expand into diabetic foot ulcers (“DFU”) and anticipated multiple other clinical indications.
  • The transaction was approved at a General Meeting of the stockholders of Spectral MD Holdings, Ltd. (“Spectral MD”) on August 31, 2023 and a Special Meeting of Rosecliff’s stockholders on September 6, 2023.

FDA Approves LimFlow System in Patients With Chronic Limb-Threatening Ischemia and No Suitable Endovascular or Surgical Revascularization Options

Retrieved on: 
Tuesday, September 12, 2023
Health, FDA, Medical Devices, Diabetes, Surgery, Clinical Trials, Cardiology, Chronic limb threatening ischemia, The New England Journal of Medicine, Vein, Amputation, CE marking, PAD, Foot, Quality of life, Leg, Multimedia, Artery, Sale, Pain, Professor, Transcatheter arterial chemoembolization, MD, Patient, Risk, Peripheral artery disease, Mortality, CLTI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Wound healing, Pharmaceutical industry, Medical device

View the full release here: https://www.businesswire.com/news/home/20230908213065/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230908213065/en/
    The LimFlow System is designed to reestablish blood flow in deep veins for "no-option" patients with Chronic Limb-Threatening Ischemia (CLTI).
  • The technology bypasses permanently blocked arteries in the leg and foot and delivers oxygenated blood back into the foot via the veins.
  • (Graphic: Business Wire)
    The LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is designed to reestablish blood flow in deep veins for “no-option” CLTI patients.
  • “We thank the FDA for their collaborative review process and we look forward to introducing and expanding use of the LimFlow System in the U.S.”
    The LimFlow System is indicated for patients who have chronic limb-threatening ischemia (CLTI) with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

TMRW Life Sciences Receives CE Mark for the CryoRobot Select, its Next-Generation Automated Platform to Safely Manage and Store Frozen Eggs and Embryos

Retrieved on: 
Tuesday, September 12, 2023
CE marking, Villalba, Failure, CRS, Software, Fertility clinic, IVF, Certification, Patient, Risk, Fertility, European, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TMRW, Food, Safety, Egg, Medical device, Pharmaceutical industry

NEW YORK, Sept. 12, 2023 /PRNewswire/ -- TMRW Life Sciences, a fertility technology company automating the IVF lab, today announced that it has received a CE Mark for the CryoRobot Select (CRS). The European designation follows clearance by the U.S. Food and Drug Administration, and the two regulatory achievements demonstrate that TMRW's automated platform for the safe management and storage of frozen eggs and embryos is now the global standard.

Key Points: 
  • The CRS modernizes a critical aspect of the IVF lab – the management and storage of frozen eggs and embryos.
  • The CRS is an automated platform that combines proprietary, state-of-the-art hardware and software to safely track, monitor and store frozen eggs and embryos.
  • Thanks to advances in assisted reproductive technology, more people are building families – and storing frozen eggs and embryos – than ever before.
  • Now with its CE Mark designation, TMRW is poised to make a significant impact in the United Kingdom and Europe as well.

TMRW Life Sciences Receives CE Mark for the CryoRobot Select, its Next-Generation Automated Platform to Safely Manage and Store Frozen Eggs and Embryos

Retrieved on: 
Tuesday, September 12, 2023
CE marking, Villalba, Failure, CRS, Software, Fertility clinic, IVF, Certification, Patient, Risk, Fertility, European, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TMRW, Food, Safety, Egg, Medical device, Pharmaceutical industry

NEW YORK, Sept. 12, 2023 /PRNewswire/ -- TMRW Life Sciences, a fertility technology company automating the IVF lab, today announced that it has received a CE Mark for the CryoRobot Select (CRS). The European designation follows clearance by the U.S. Food and Drug Administration, and the two regulatory achievements demonstrate that TMRW's automated platform for the safe management and storage of frozen eggs and embryos is now the global standard.

Key Points: 
  • The CRS modernizes a critical aspect of the IVF lab – the management and storage of frozen eggs and embryos.
  • The CRS is an automated platform that combines proprietary, state-of-the-art hardware and software to safely track, monitor and store frozen eggs and embryos.
  • Thanks to advances in assisted reproductive technology, more people are building families – and storing frozen eggs and embryos – than ever before.
  • Now with its CE Mark designation, TMRW is poised to make a significant impact in the United Kingdom and Europe as well.

VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel Prep™ System

Retrieved on: 
Wednesday, September 6, 2023
Medical device, CE, Medical Devices Directive, CE marking, PAD, FLEX, Moyamoya disease, Quality, Certification, MDR, Patient, European Economic Area, Patient safety

MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.

Key Points: 
  • MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.
  • Gaining MDR certification ensures the FLEX device is in alignment with described requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area.
  • "CE Mark under these new requirements is more stringent than the CE Mark under the Medical Device Directive and is focused on quality as well as patient safety.
  • "MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE marked geographies."

VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel Prep™ System

Retrieved on: 
Wednesday, September 6, 2023
Medical device, CE, Medical Devices Directive, CE marking, PAD, FLEX, Moyamoya disease, Quality, Certification, MDR, Patient, European Economic Area, Patient safety

MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.

Key Points: 
  • MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.
  • Gaining MDR certification ensures the FLEX device is in alignment with described requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area.
  • "CE Mark under these new requirements is more stringent than the CE Mark under the Medical Device Directive and is focused on quality as well as patient safety.
  • "MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE marked geographies."

LivaNova Unveils Essenz In-Line Blood Monitor with U.S. FDA 510(k) Clearance and CE Mark

Retrieved on: 
Wednesday, August 30, 2023
Cardiology, Software, Health, FDA, Medical Devices, Health Technology, Technology, Other Health, Partnership, PLC, ILBM, LIVN, Perfusion, Hematocrit, Oxygen, CE marking, Food and Drug Administration, LivaNova, CPB, Multimedia, Temperature, Cardiopulmonary bypass, Sale, United Arab Emirates, CLIA, Journal, Acute kidney injury, GDP, Patient, Risk, Stazione Sperimentale per le Industrie delle Essenze e dei Derivati dagli Agrumi, Clinical Laboratory Improvement Amendments, Perfusionist, HLM, Partial pressure, Food, Monitoring (medicine), Medical device, Medical imaging

LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.

Key Points: 
  • LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Mark for its Essenz™ In-Line Blood Monitor (ILBM), which provides accurate and continuous measurement of essential blood parameters to perfusionists throughout cardiopulmonary bypass (CPB) procedures.
  • “Dynamic conditions can rapidly change a patient’s blood parameters during a cardiopulmonary bypass procedure,” said Marco Dolci, LivaNova President, Cardiopulmonary.
  • “The Essenz In-Line Blood Monitor provides continuous monitoring throughout a patient’s procedure.
  • It consists of a next-generation heart-lung machine (HLM), a patient monitor and accurate sensing technology that now includes the ILBM.

Telesair Receives CE Mark for Bonhawa High Flow Oxygen Therapy System

Retrieved on: 
Tuesday, August 22, 2023
Medical Devices, Hospitals, Health, Health Technology, Nursing, Failure mode and effects analysis, CE marking, Long-term care, Light, Hospital, Patient, Disinfectant, Workload, European Medical Students' Association, Caregiver, Medical device

Telesair, Inc. , an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency.

Key Points: 
  • Telesair, Inc. , an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency.
  • “Having our Bonhawa system approved for Europe is a major step in the evolution of Telesair as a company and opens the many markets which accept CE Mark,” said Bryan Liu, CEO of Telesair.
  • Telesair’s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company’s existing market access that includes Latin America and Southeast Asia.
  • Telesair’s solutions are designed to elevate the existing standard of care by improving outcomes for patients and the health system.

Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer

Retrieved on: 
Tuesday, August 22, 2023
Genetically modified food in the European Union, DNA, MMR, CE marking, TMB, LGR, Microsatellite instability, HRD, Bone marrow, NGS, Cancer, DNA mismatch repair, Multimedia, RNA, CNV, Drug resistance, Chromosomal translocation, MSI, Genetic testing, SNV calling from NGS data, PARP, Gene, Vaccine

TORONTO, Aug. 22, 2023 /PRNewswire/ - Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union's CE Mark approval.

Key Points: 
  • TORONTO, Aug. 22, 2023 /PRNewswire/ - Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union's CE Mark approval.
  • These approvals signify that GeneseeqPrime™ and GeneseeqPrime™ HRD are suitable for solid tumor genomic profiling, while Hemasalus™ DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling.
  • In addition to the CE-Marked GENESEEQ multi-cancer minimal residual disease detection (Shielding™ ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan™ MCED) kits introduced earlier this year , Geneseeq currently offers five CE-marked cancer genetic testing kits tailored for various clinical situations.
  • These kits will now be accessible to healthcare professionals in Europe, enabling them to formulate treatment plans for individuals affected by cancer.

OrbusNeich FY2023 Interim Net Profit Triples to US$25.2 Million, Total Revenue Increases by 18.2% to US$81.4 Million

Retrieved on: 
Thursday, August 17, 2023
Percutaneous coronary intervention, CE, Medical device, PTA, Marketing, Medical Devices Directive, ISO, Abbott, CE marking, Clinical trial, Sapphire, Quality of life, OrbusNeich, Medical device regulation, Certification, PCI, MDR, Acquisition, MDD, Patient, Developed country, Physician, PMDA, FX, Capacity, Teleport, Growth, R, FDA, Family, NMPA, Renewable energy, Pharmaceutical industry, PRC

Gross profit rose by 22.1% to approximately US$58.3 million, with a gross profit margin of 71.6%.

Key Points: 
  • Gross profit rose by 22.1% to approximately US$58.3 million, with a gross profit margin of 71.6%.
  • As a result, profit attributable to the owners of the Company reached US$25.2 million, an increase of 213.3%, with a net profit margin of 30.9%.
  • Adjusted profit (non-HKFRS measure) (1) increased by 105.6% year-on-year to approximately US$25.4 million.
  • As at 30 June 2023, the Group was in a strong financial position with cash and bank balances of approximately US$239.0 million.