Latest news with #ISO13485-certified
Korea Herald
18-07-2025
- Business
- Korea Herald
MFDS Clears DeepQure's HyperQure™ for Clinical Trial in Atrial Fibrillation
SEOUL, South Korea, July 18, 2025 /PRNewswire/ -- DeepQure announced today that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ RDM System, the company's novel laparoscopic renal denervation (RDN) system, for the treatment of atrial fibrillation (AF). The trial is designed to evaluate the safety and efficacy of laparoscopic RDN in patients with recurrent AF following pulmonary vein isolation (PVI) and resistant hypertension. It will be conducted as a multicenter, prospective, single-arm, open-label exploratory study. HyperQure™ is a next-generation laparoscopic RDN device developed over the past decade under the leadership of Professor Chang-Wook Jeong at Seoul National University Hospital. By adopting an extravascular approach, HyperQure™ addresses key limitations of conventional intravascular RDN, offering direct anatomical access to renal nerves with the potential for improved precision and outcomes. DeepQure is also conducting RDN clinical trials for resistant hypertension in both South Korea and the United States. Patient enrollment is nearing completion domestically, while trials are actively underway at five major academic medical centers across the U.S. The MFDS's approval for this new indication marks an important milestone, expanding HyperQure™'s potential from hypertension to atrial fibrillation and reinforcing its technical scalability and multi-disease therapeutic potential. HyperQure™ is ISO 13485–certified, GMP-compliant, and was designated as Innovative Medical Device No. 36 by the MFDS, underscoring its clinical relevance and breakthrough innovation. "This approval validates HyperQure™ as a next-generation solution that overcomes the limitations of traditional RDN techniques," said a DeepQure spokesperson. "With parallel trials in resistant hypertension and now atrial fibrillation, we are accelerating our push into the global cardiovascular market with a truly differentiated solution." About DeepQure DeepQure is a medical technology company pioneering minimally invasive therapies for cardiovascular and autonomic nervous system disorders. Founded by experts in clinical medicine, engineering, and global healthcare, the company is focused on developing breakthrough solutions that address unmet needs in cardiovascular diseases. DeepQure is headquartered in Seoul, South Korea, with clinical programs active in both Korea and the United States. About HyperQure™ RDN System HyperQure™ is DeepQure's proprietary laparoscopic renal denervation (RDN) system designed to treat conditions such as resistant hypertension and atrial fibrillation. Unlike conventional intravascular approaches, HyperQure™ utilizes an extravascular route to access and ablate renal nerves with enhanced precision. The system has been designated as an Innovative Medical Device by the Korean MFDS and has obtained ISO 13485 and GMP certifications, enabling global clinical deployment.
Yahoo
01-05-2025
- Business
- Yahoo
Natera to Report its First Quarter Results on May 8, 2025
AUSTIN, Texas, May 01, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that it will release results for its first quarter ended March 31, 2025, after the market closes on May 8, 2025. Natera will host a conference call and webcast shortly thereafter at 1:30 p.m. PT (4:30 p.m. ET). Earnings Conference Call Information Event: Natera's First Quarter 2025 Financial Results Date: May 8, 2025 Time: 1:30 p.m. PT (4:30 p.m. ET) Live Dial-In: 1-888-596-4144 (Domestic) 1-646-968-2525 (International) Conference ID: 7684785 Webcast: A webcast replay will be available at About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 250 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Sign in to access your portfolio
Yahoo
04-03-2025
- Business
- Yahoo
Natera Expands Intellectual Property Portfolio With New Patents in Tumor-Informed MRD
AUSTIN, Texas, March 04, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced that the U.S. Patent and Trademark Office has issued Natera a new patent related to testing of single nucleotide variants in circulating-tumor DNA (ctDNA). This builds on Natera's extensive intellectual property estate, including a strong portfolio of molecular residual disease testing (MRD) patents for whole exome and whole genome sequencing. U.S. patent No. 12,203,142 relates to certain methods of preparation useful for tumor-informed ctDNA monitoring using whole exome or whole genome sequencing. The patent describes various modes of target enrichment in the plasma, including both multiplex polymerase chain reaction PCR and capture by hybridization. Natera has more than 110 patents relating to cell-free DNA analysis for oncology testing, including 23 patents obtained in 2024. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to the scope of protection we establish and maintain for our intellectual property or other proprietary rights. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at and View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Sign in to access your portfolio
