MDSAP

DGAP-News: Mercury Medical Inc.: Mercury Medical's Tim Gargaro, chosen as CFO Business Panel member by the Federal Reserve Bank of Atlanta

Retrieved on: 
Wednesday, August 17, 2022
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To make sound policy decisions in a shifting landscape, policymakers look to business leaders participating in the CFO Business Panel to learn more about their expectations, the challenges they face, and their overall view of economy.

Key Points: 
  • To make sound policy decisions in a shifting landscape, policymakers look to business leaders participating in the CFO Business Panel to learn more about their expectations, the challenges they face, and their overall view of economy.
  • The CFO Business Panel provides quarterly input to the Federal Reserve Bank of Atlanta.1
    A byproduct of the CFO Business Panel is the CFO Survey.
  • Started in 1996 by Duke University's Fuqua School of Business, the quarterly survey is now conducted in partnership with the Federal Reserve Banks of Richmond and Atlanta.
  • Tim Gargaro states, "I am honored to be a part of the Mercury Medical team and to receive the invitation to join this prestigious CFO Business Panel of The Federal Reserve Bank of Atlanta.

Vena Medical Celebrates First Procedures with Category-Defining Balloon Distal Access Catheter™ (BDAC)

Retrieved on: 
Tuesday, August 16, 2022
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The Vena BDAC combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke victims.

Key Points: 
  • The Vena BDAC combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke victims.
  • Other centres included in the VANISH trial and/or evaluating the Vena BDAC are London Health Sciences Centre-University Hospital (Drs.
  • Vena Medical, an ISO 13485 and MDSAP certified company, is creating a suite of tools to change the way physicians perform minimally invasive neurosurgery, starting with the Vena Balloon Distal Access Catheter, currently available in Canada.
  • Vena Medical is part of the MIX (Medical Innovation Xchange) group of companies https://medicalinnovationxchange.com .

Vena Medical Celebrates First Procedures with Category-Defining Balloon Distal Access Catheter™ (BDAC)

Retrieved on: 
Tuesday, August 16, 2022
Xchange, FDA, Journal of NeuroInterventional Surgery, The Ottawa Hospital, Principal, LVO, CEO, GLOBE, Technology, American Journal of Neuroradiology, Children's Hospital at London Health Sciences Centre, DRS, Thrombectomy, Neuroradiology, University of Alberta Hospital, Recce (filmmaking), LHSC, Vein, Patient, Thrombus, Stroke, Neurology, American Journal, Teaching hospital, MDSAP, Vena, London Health Sciences Centre, Physician, Journal, Foothills Medical Centre, University, TOH, AIS, MIX, Artery, Medical device

The Vena BDAC combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke victims.

Key Points: 
  • The Vena BDAC combines the balloon guide catheters and distal access catheters that are currently used in thrombectomy to remove clots from the brains of stroke victims.
  • Other centres included in the VANISH trial and/or evaluating the Vena BDAC are London Health Sciences Centre-University Hospital (Drs.
  • Vena Medical, an ISO 13485 and MDSAP certified company, is creating a suite of tools to change the way physicians perform minimally invasive neurosurgery, starting with the Vena Balloon Distal Access Catheter, currently available in Canada.
  • Vena Medical is part of the MIX (Medical Innovation Xchange) group of companies https://medicalinnovationxchange.com .

ClearPoint Neuro Reports Second Quarter 2022 Results

Retrieved on: 
Tuesday, August 9, 2022
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SOLANA BEACH, Calif., Aug. 09, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its second quarter ended June30, 2022.

Key Points: 
  • SOLANA BEACH, Calif., Aug. 09, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its second quarter ended June30, 2022.
  • The ClearPoint Neuro Team has continued to execute against our four-pillar growth strategy in the second quarter, commented Joe Burnett, President and CEO.
  • Operating expenses for the second quarter of 2022 were $7.5 million, compared to $5.7 million for the second quarter of 2021.
  • Investors and analysts are invited to listen to a live broadcast review of the Company's 2022 second quarter on Tuesday, August9, 2022 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) which may be accessed online here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=LzXg7k1V .

Establishment Labs Reports Record Second Quarter 2022 Financial Results

Retrieved on: 
Monday, August 8, 2022
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Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the second quarter ended June 30, 2022.

Key Points: 
  • Establishment Labs Holdings Inc. (Nasdaq: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced its financial results for the second quarter ended June 30, 2022.
  • Second quarter operating expenses of $37.9 million, an increase of 45.0% compared to the second quarter of 2021.
  • The strong momentum in our business continued in the second quarter of 2022, said Juan Jos Chacn-Quirs, Chief Executive Officer.
  • Second quarter revenue of $41.2 million was up 28.7% from the second quarter of 2021; excluding the impact of the stronger U.S. dollar, which reduced reported revenue by approximately $1.5 million, growth in the second quarter would have been 33.3%.

Establishment Labs Announces Complete Enrollment in Motiva US IDE Study

Retrieved on: 
Wednesday, August 3, 2022
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Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced it has completed enrollment in the Motiva US IDE clinical study.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced it has completed enrollment in the Motiva US IDE clinical study.
  • The Augmentation cohort, which finished enrollment in August of 2019, will complete its third year of study follow-up this month.
  • The Motiva US IDE study enrolled 827 patients at 32 centers in the US, Germany, and Sweden.
  • Having completed full enrollment in the IDE study across all patient groups, we are diligently working with the plastic surgeons in the trial to maintain high patient follow-up, said Juan Jos Chacn-Quirs, Founder and CEO of Establishment Labs.

DGAP-News:  Mercury Medical Receives EU Quality Management Medical Device (MDR) Certification

Retrieved on: 
Wednesday, July 27, 2022
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CLEARWATER, FL / ACCESSWIRE / July 27, 2022 / Mercury Medical recently received MDR CE Mark Certification for their CPR manual resuscitation line.

Key Points: 
  • CLEARWATER, FL / ACCESSWIRE / July 27, 2022 / Mercury Medical recently received MDR CE Mark Certification for their CPR manual resuscitation line.
  • This certification ensures the quality system is in accordance with Regulation (EU) 2017/745 allowing for CPR product line sales in the European market.
  • The EU Medical Device Registration (MDR) replaces the EU's Medical Device Directive (93/42/EECI) thatwent into effect in May of 2021.According to the European Commission, (EC), no existing requirements have been removed but new requirements have been added to the MDR.
  • John Gargaro MD, President and CEO at Mercury Medical, states: "This is a HUGE milestone requiring a tremendous amount of resources to achieve MDR certification.

TÜV SÜD America Inc. announces that it has achieved membership with CSA STAR as a Certification Body allowing TÜV SÜD to provide CSA STAR audits

Retrieved on: 
Tuesday, July 26, 2022
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TV SD America Inc. announced today that it had been joined CSA STAR as a Certification Body allowing them to provide CSA STAR audits.

Key Points: 
  • TV SD America Inc. announced today that it had been joined CSA STAR as a Certification Body allowing them to provide CSA STAR audits.
  • CSA Star Level Two Certifications adds to TV SD America Incs Cybersecurity portfolio allowing TV SD to provide a holistic cybersecurity certification service from CE Marking to IT Infrastructure through to Cloud.
  • Gaining CSA STAR certification allows cloud service providers to demonstrate to customers their security and compliance posture, including the regulations, standards, and frameworks they adhere to.
  • TV SD America Inc., a subsidiary of TV SD AG (Munich, Germany), is a leading globally recognized testing and certification organization.

Establishment Labs to Announce Second Quarter 2022 Financial Results on August 8

Retrieved on: 
Monday, July 25, 2022
Surgery, Medical Devices, Other Health, Health, Medical Supplies, NASDAQ, ESTA, Motiva, MDSAP, IDE, Clinical trial, International, 21 CFR 820, FDA, Diversified Specialty Institute Holdings, Inc., Medical device

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2022 after the market closes on Monday, August 8, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, plans to announce its financial results for the quarter ended June 30, 2022 after the market closes on Monday, August 8, 2022, and will host a conference call at 4:30 pm ET that day to discuss those results.
  • To participate in the conference call, dial (877) 407-8037 (U.S. and Canada) or (201) 689-8037 (International) and use conference ID number 13731615.
  • The call will also be available via live or archived webcast on the Investor Relations section of the Establishment Labs website at www.establishmentlabs.com .
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Legend Capital Portfolio Company: The Global-Leading AI Medical Imaging Company Lunit Goes Public Successfully

Retrieved on: 
Thursday, July 21, 2022
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Lunit SCOPE is an AI biomarker for immunotherapy, providing therapy response information that can critically affect treatment outcomes for cancer patients.

Key Points: 
  • Lunit SCOPE is an AI biomarker for immunotherapy, providing therapy response information that can critically affect treatment outcomes for cancer patients.
  • For the past 4 years, Lunit not only has produced world-leading AI medical solutions but also gained its commercial value achieving rapid topline growth.
  • Legend Capital has invested heavily in companies that integrate technology and the medical industry and has kept betting on AI medical sectors.
  • In addition to Lunit, Legend Capital has also invested in AI medical companies such as Xbiome, an AI microbiome drug development company; StoneWise, an AI drug R&D platform; Deepwise, an AI medical imaging company; BioMap, a biocomputing platform; Deep Informatics ++, an AI medical pathology diagnosis company; and Unimed, an AI brain diagnosis and treatment platform.