Investigational device exemption

OPTIMIZE Study Reports Lowest TLR Ever Achieved in an Investigational Device Exemption (IDE) Study With Svelte Medical System’s Bioresorbable Coated Drug-Eluting Coronary Stent

Saturday, October 17, 2020 - 5:00pm

The Svelte Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study.

Key Points: 
  • The Svelte Drug-Eluting Stent (DES) achieved 1.5% clinically-driven Target Lesion Revascularization (TLR) at 1 year, the lowest ever reported in an Investigational Device Exemption (IDE) clinical study.
  • The high TLF reported in both OPTIMIZE treatment groups is driven by the 25% of study subjects assessed peri-procedurally with high-sensitivity-troponin.
  • We are deeply grateful to each and every one of the patients, investigative team members and support personnel contributing to the OPTIMIZE study.
  • Headquartered in New Providence, New Jersey, Svelte Medical Systems ( www.sveltemedical.com ) is a privately-held company engaged in the development of highly deliverable balloon expandable stents.

Pulse Biosciences Announces FDA IDE Approval and Initiation of Sebaceous Hyperplasia Study

Thursday, October 1, 2020 - 12:30pm

Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System.

Key Points: 
  • Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation (NPS) technology, today announced FDA Investigational Device Exemption (IDE) approval and initiation of a pivotal study to evaluate the treatment of sebaceous hyperplasia (SH) lesions using the CellFX System.
  • Following IDE approval, several patients have been enrolled, with the first patient procedure completed on September 28, 2020.
  • We are pleased to have received FDA IDE approval and to have begun this important SH comparative study slightly ahead of the fourth quarter start we had previously communicated.
  • Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries.

Endospan Receives FDA IDE Approval to Initiate a Pivotal Study of the NEXUS™ Aortic Arch Stent Graft System

Monday, August 17, 2020 - 1:00pm

Endospan , a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM).

Key Points: 
  • Endospan , a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM).
  • The TRIOMPHE pivotal study will assess the NEXUSTM in some of the most challenging Aortic Arch Pathologies that we encounter.
  • Endospans NEXUSTM Aortic Arch Stent Graft System is the first endovascular off-the-shelf system with CE Mark to treat a greatly underserved group of patients diagnosed with a dilative lesion in, or near the aortic arch.
  • NEXUSTM Aortic Arch Stent Graft System is currently available for sale in Europe and is intended for investigational use only in the U.S.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20200817005127/en/

Cleveland Clinic Joins Interventional Study Using GRAIL’s Multi-Cancer Early Detection Test to Help Guide Clinical Care

Thursday, August 6, 2020 - 2:00pm

GRAIL, Inc., a healthcare company whose mission is to detect cancer early, announced today that Cleveland Clinic has joined GRAILs PATHFINDER Study, a prospective, multi-center clinical study that is evaluating the implementation of Galleri, an investigational multi-cancer early detection blood test, into clinical practice for the first time.

Key Points: 
  • GRAIL, Inc., a healthcare company whose mission is to detect cancer early, announced today that Cleveland Clinic has joined GRAILs PATHFINDER Study, a prospective, multi-center clinical study that is evaluating the implementation of Galleri, an investigational multi-cancer early detection blood test, into clinical practice for the first time.
  • Cleveland Clinic joins initial PATHFINDER health system partners that include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health.
  • The PATHFINDER Study is conducted under an investigational device exemption (IDE) application approved by the Food and Drug Administration (FDA) to evaluate GRAILs multi-cancer early detection test.
  • The PATHFINDER Study is evaluating the implementation of GRAILs investigational multi-cancer early detection test in clinical practice, and marks the first time Galleri will be used to return results to people.

Vivos Inc Receives Grant of Protection for RadioGel™ Therapy in China

Wednesday, July 22, 2020 - 12:00pm

Richland WA, July 22, 2020 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos announced it received the Grant of Protection for the Radiogel trademark application in China.

Key Points: 
  • Richland WA, July 22, 2020 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos announced it received the Grant of Protection for the Radiogel trademark application in China.
  • The mark is now officially registered in China until April 21, 2024, with the opportunity to extend for an additional 10 years.
  • As we work towards the Investigational Device Exemption milestone with FDA, we will be pursuing international licensing opportunities and the grant of the Radiogel trademark in China enhances the value for potential partners.
  • Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (Isopet) and in humans (Radiogel).

Bioventus Makes $15 Million Equity Investment in CartiHeal with an Agreed Option Structure to Acquire Company Upon Milestone Achievements

Thursday, July 16, 2020 - 2:20pm

The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeals investigational device exemption (IDE) multinational pivotal study.

Key Points: 
  • The investment follows the recently completed enrollment and outcome of interim analysis in CartilHeals investigational device exemption (IDE) multinational pivotal study.
  • An additional $5 million can be secured by CartiHeal from Bioventus, if needed, for IDE study completion.
  • Bioventus made an initial $2.5 million investment in the Agili-C IDE study in January 2018, as part of a previous financing round.
  • Bioventus and CartiHeal have agreed on an option structure under which Bioventus will acquire the company shortly after FDA approval of the Agili-C implant.

Biotricity FDA Submission Update

Thursday, May 21, 2020 - 1:00am

The Company is confident in its FDA submission process, having received two previous 510(k)s for its Bioflux Device and Bioflux Software.

Key Points: 
  • The Company is confident in its FDA submission process, having received two previous 510(k)s for its Bioflux Device and Bioflux Software.
  • A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, at the very least, as a legally marketed device.
  • This FDA submission highlights Biotricitys focus on innovation and expansion of its technology.
  • Biotricity has a track record in receiving FDA 510(k)s and is confident in the process.

Balt Receives IDE Approval From the FDA to Begin the STEM Trial

Friday, May 15, 2020 - 12:38am

Balt announced today it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma.

Key Points: 
  • Balt announced today it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin The Squid Trial for the Embolization of the Middle meningeal artery (STEM) for the treatment of chronic Sub-Dural Hematoma.
  • A recent Veterans Affairs (VA) study of cSDH found a prevalence rate of 79.4 per 100,000 persons.
  • The clinical trial is a prospective, randomized controlled trial.
  • Dr. Arthur said, This is a disease which affects a large number of people, and preys particularly on the elderly.

FDA Grants Vapotherm® Oxygen Assist Module (OAM™) Breakthrough Device Designation

Thursday, April 9, 2020 - 11:00am

Vapotherm, Inc. (NYSE: VAPO) (Vapotherm or the Company), a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Device Designation for the Companys Oxygen Assist Module (OAM).

Key Points: 
  • Vapotherm, Inc. (NYSE: VAPO) (Vapotherm or the Company), a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug Administration (FDA) recently granted Breakthrough Device Designation for the Companys Oxygen Assist Module (OAM).
  • Separately, Vapotherm submitted an Investigational Device Exemption (IDE) for pediatric use of OAM to FDA.
  • Vapotherm OAM is a module for use with most versions of Vapotherms Precision Flow systems.
  • When used with the Precision Flow system, the Vapotherm OAM assists staff in maintaining a targeted SpO2 (amount of oxygen in the blood) range.

Daré Bioscience Receives Third Notice of Award from National Institutes of Health Eunice Kennedy Shriver National Institute of Child Health and Human Development for the Development of Ovaprene®

Wednesday, April 1, 2020 - 1:00pm

This award notice is timely, as we plan to file an Investigational Device Exemption application with the FDA to support the ongoing development of Ovaprene later this year.

Key Points: 
  • This award notice is timely, as we plan to file an Investigational Device Exemption application with the FDA to support the ongoing development of Ovaprene later this year.
  • Dar plans to continue to pursue non-dilutive funding opportunities to support the further development of its product candidates.
  • This press release discusses research supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of theNational Institutes of Healthunder Award Number R44HD095724.
  • Dar Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for womens health.