Estar

United Health Products Reports on FDA Application Status

Retrieved on: 
Tuesday, October 3, 2023
UHP, File, Ageing, Sterilization, PMA, Tyvek, Estar, PDF, FDA, Health Canada, Medical device

MESQUITE, NV, Oct. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.

Key Points: 
  • MESQUITE, NV, Oct. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.
  • The company reports today that the packaging testing process is substantially completed with no non-conforming results.
  • In anticipation of re-submitting updated PMA information, UHP has engaged regularly with the FDA.
  • There can be no assurance that the company’s PMA or Health Canada applications will be approved.

ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA

Retrieved on: 
Wednesday, August 30, 2023
Health Technology, Health, Other Health, Medical Devices, Fatty liver disease, De novo, Non-alcoholic fatty liver disease, NDRA, Patient, De novo synthesis, Estar, NAFLD, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).
  • “We are very pleased that our FDA De Novo submission has advanced to the substantive review stage," stated ENDRA's Chairman and Chief Executive Officer Francois Michelon.
  • On August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system.
  • On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period.

Medcrypt launches new FDA Cybersecurity Readiness Services to prepare medical device manufacturers for upcoming changes to regulations

Retrieved on: 
Wednesday, August 9, 2023
RTA, Safety, Omnibus spending bill, Act, Policy, Federal Food, Drug, and Cosmetic Act, Quality, SAN, Royal Commission into Aged Care Quality and Safety, Estar, Consolidated Appropriations Act, 2022, FDA, MDM, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Letter, FD, Food, Risk management, Medical device

SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023.

Key Points: 
  • SAN DIEGO, Aug. 9, 2023 /PRNewswire/ -- Medcrypt, Inc. , the proactive cybersecurity solution provider for medical device manufacturers, announced its latest offering today, "FDA Cybersecurity Readiness Services" empowering medical device manufacturers (MDMs) to confidently navigate the U.S. Food and Drug Administration's (FDA) Refuse to Accept (RTA) policy as well as the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023 .
  • "We developed the FDA Cybersecurity Readiness Services to address the growing demand from medical device manufacturers seeking guidance through the complex and evolving submission process.
  • Interested in ensuring your medical devices comply with FDA cybersecurity expectations (both requirements per the Act and recommendations per cybersecurity guidance)?
  • Inquire with Medcrypt to learn more about our FDA Cybersecurity Readiness Services, designed to guide medical device manufacturers through the new 510(k) eSTAR submission requirement and the cybersecurity Refuse to Accept (RTA) policy and streamline the path to regulatory approval.

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

Retrieved on: 
Monday, June 12, 2023
Medical device, Pregnancy, EU, Food and Drug Administration, Intelligence, II, MDR, HIV disease progression rates, Patient, Risk, Algorithm, Estar, IEC, Diagnosis, Heart rate, FDA, Therapy, Health Canada, Self-management, Food, Safety, Software

Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy.

Key Points: 
  • Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy.
  • Class II level clearance permits Huma's platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication.
  • Watch Dan explain the importance of FDA Class II clearance to Huma and to the field of digital health.
  • Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona, said: "I am delighted to see Huma achieve Class II clearance from the US FDA for its technology platform.

Huma receives multi-condition US FDA 510(k) Class II regulatory clearance for its configurable SaMD disease management platform

Retrieved on: 
Monday, June 12, 2023
Medical device, Pregnancy, EU, Food and Drug Administration, Intelligence, II, MDR, HIV disease progression rates, Patient, Risk, Algorithm, Estar, IEC, Diagnosis, Heart rate, FDA, Therapy, Health Canada, Self-management, Food, Safety, Software

Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy.

Key Points: 
  • Achieving Class II clearance means the platform is permitted to monitor patients of all ages with any condition - including paediatrics, and in pregnancy.
  • Class II level clearance permits Huma's platform to host artificial intelligence algorithms that use automated data analytics to support screening, diagnosis, dosing recommendations, clinical decision making and prognostication.
  • Watch Dan explain the importance of FDA Class II clearance to Huma and to the field of digital health.
  • Dr Rishi Patel, Cardiology Service Line Medical Director, Banner Medical Group, Arizona, said: "I am delighted to see Huma achieve Class II clearance from the US FDA for its technology platform.

New report: 2022 was record-breaking year for U.S. product recalls

Retrieved on: 
Thursday, March 2, 2023
United States Department of Agriculture, FTC, FDA, Federal Trade Commission, PFAS, Policy, Car, Consolidated Appropriations Act, 2022, Food, Omnibus spending bill, U.S. Consumer Product Safety Commission, Marketing, Estar, CPSC, Food and Drug Administration, United States Environmental Protection Agency, EVS, USDA, EPA, Medical device, Automotive industry, Pharmaceutical industry

MEMPHIS, Tenn., March 2, 2023 /PRNewswire/ -- For the second consecutive year, more than 1 billion units of food, drugs, medical devices, automobiles, and consumer products were recalled in the U.S. According to Sedgwick's latest state of the nation recall index report, 2022 was a record-breaking year for the number of units recalled, reaching nearly 1.5 billion. With regulatory scrutiny continuing to increase, 2023 may shape up to be another 1 billion unit year, requiring businesses across industries to remain vigilant on matters of product safety and recall preparedness.

Key Points: 
  • Automotive recalls decreased 12.6% in 2022 compared to 2021.
  • While the number of consumer product recalls increased by nearly a third (31.2%) in 2022 over 2021, the number of units recalled almost halved (45.4%), from 42.8 million in 2021 to 23.4 million in 2022.
  • FDA food recalls experienced a 700.6% increase in the number of units impacted in 2022.
  • Recall events in the medical device industry increased by 8.8% in 2022, up from 837 events in 2021 to 911.

The ITC Complaint Against Estar Medical in the U.S. Is Withdrawn by Regenlab

Retrieved on: 
Thursday, March 5, 2020
Estar, Navistar International, Companies

Regenlab USA LLC, a subsidiary of Regen Lab SA ("Regenlab") has withdrawn its U.S. International Trade Commission ("ITC") complaint against Estar Technologies Ltd. ("Estar Medical") and Eclipse Medcorp LLC (Inv.

Key Points: 
  • Regenlab USA LLC, a subsidiary of Regen Lab SA ("Regenlab") has withdrawn its U.S. International Trade Commission ("ITC") complaint against Estar Technologies Ltd. ("Estar Medical") and Eclipse Medcorp LLC (Inv.
  • In its pre-trial brief submitted to the administrative law judge, the ITC's official Investigative Staff Attorney ("Staff Attorney"), agreed with Estar Medical that the asserted claims of Regenlab's US Patent No.
  • Estar Medical filed an opposition against Regenlab's European PRP Patent in 2017, and the patent was revoked following a hearing inApril 2019.
  • Estar Medical also defeated Regenlab inGermany and in the U.S. federal district court,winning a non-infringement judgment in the former and obtaining a dismissal in the latter.

The ITC Complaint Against Estar Medical in the U.S. is Withdrawn by Regenlab

Retrieved on: 
Thursday, March 5, 2020
Estar, Navistar International, Companies

Regenlab USA LLC, a subsidiary of Regen Lab SA ("Regenlab") has withdrawn its U.S. International Trade Commission ("ITC") complaint against Estar Technologies Ltd. ("Estar Medical") and Eclipse Medcorp LLC (Inv.

Key Points: 
  • Regenlab USA LLC, a subsidiary of Regen Lab SA ("Regenlab") has withdrawn its U.S. International Trade Commission ("ITC") complaint against Estar Technologies Ltd. ("Estar Medical") and Eclipse Medcorp LLC (Inv.
  • In its pre-trial brief submitted to the administrative law judge, the ITC's official Investigative Staff Attorney ("Staff Attorney"), agreed with Estar Medical that the asserted claims of Regenlab's US Patent No.
  • Estar Medical filed an opposition against Regenlab's European PRP Patent in 2017, and the patent was revoked following a hearing inApril 2019.
  • Estar Medical also defeated Regenlab inGermany and in the U.S. federal district court,winning a non-infringement judgment in the former and obtaining a dismissal in the latter.

Estar Medical Wins Patent Infringement Lawsuit Against Regenlab

Retrieved on: 
Tuesday, June 19, 2018
Platelet-rich plasma, Patent infringement, Estar

The Regional Dusseldorf District Court entirely dismissed the Regenlab infringement claim against Estar Medical, concludes no infringement of patents

Key Points: 
  • The Regional Dusseldorf District Court entirely dismissed the Regenlab infringement claim against Estar Medical, concludes no infringement of patents
    Estar Technologies Ltd. (Estar Medical), a leading global developer and manufacturer of innovative medical technologies in the biologics, regenerative medicine and platelet rich plasma (PRP) fields, today announced that on June 5, 2018, the Dusseldorf Regional Court ruled in favor of Estar Medical in the patent infringement lawsuit initiated by Regenlab SA.
  • "We are pleased that the Dusseldorf Court ruled in Estar Medical's favor, agreeing that Estar did not infringe the Regenlab patent.
  • Estar Medical has remained confident in its non-infringement positions since the case was first filed in 2016.
  • For more information about Estar Medical or its PRP and Cell Therapy technology and products, please visit http://www.estar-medical.com .