Medical Devices

NEUSPERA MEDICAL® ANNOUNCES SECOND PHASE OF SANS-UUI IDE CLINICAL TRIAL WITH THE NUVELLA™ SYSTEM

06/22/2022

Pivotal trial to study the safety and efficacy of sacral nerve stimulation in patients with urinary urgency incontinence symptoms Excerpt from the Press Release: SAN JOSE, Calif., June 14, 2022 /PRNewswire/ — Neuspera® Medical, a medical device company developing implantable devices for patients battling chronic illnesses, today announced it will begin enrollment in its pivotal clinical trial…

Read More

PROCEPT BioRobotics Corporation Announces Additional Positive Coverage Policies Regarding Aquablation Therapy for Men with Enlarged Prostates

06/16/2022

Excerpt from the Press Release: REDWOOD CITY, Calif., June 09, 2022 (GLOBE NEWSWIRE) — PROCEPT® BioRobotics Corporation (Nasdaq: PRCT), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced that five new regional private insurance plans have issued positive coverage policies of Aquablation therapy for the surgical treatment of benign…

Read More

OncXerna Therapeutics Announces Upcoming ASCO Poster Featuring Data Showing the Phase 2 Glioblastoma Trial of Bavituximab with Chemoradiation and Adjuvant Temozolomide Met its Primary Endpoint

06/09/2022

Trial’s 73% twelve-month overall survival rate in newly diagnosed glioblastoma patients compares favorably to historical benchmark of 60% Results show median progression-free survival of 6.9 months and median overall survival of 15.4 months Treatment led to depletion of immunosuppressive myeloid-derived suppressor cells within the tumor microenvironment, suggesting bavituximab may synergistically combine with checkpoint inhibitors Excerpt…

Read More

Nexus Medical Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test Using the RHINOstic™ Automated Nasal Swab from Rhinostics

06/03/2022

Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…

Read More

Black Diamond Therapeutics Announces Publication of New Computational and Functional Analyses of HER2 Mutations Based on its Proprietary MAP Discovery Engine

05/19/2022

– Peer-reviewed publication highlights 22 new oncogenic HER2 driver mutations identified and experimentally validated with MAP discovery engine – Excerpt from the Press Release: CAMBRIDGE, Mass. and NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, today…

Read More

NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine

05/02/2022

Peer-reviewed results from the two-level multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF Excerpt from the Press Release: SAN DIEGO, April 21, 2022 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Disc (Simplify Disc) two-level U.S. Food…

Read More

Purigen Launches Ionic® Cells to Pure DNA Kit for White Blood Cell and Peripheral Blood Mononuclear Cell Control Samples

04/28/2022

New kit enhances menu of FFPE solutions and allows oncology researchers to extract higher yields of concentrated DNA compared to traditional techniques Excerpt from the Press Release: PLEASANTON, Calif.–(BUSINESS WIRE)–Purigen Biosystems, Inc., a leading provider of next-generation technologies for extracting and purifying nucleic acids from biological samples, today announced the launch of the Ionic Cells…

Read More

Exo® Announces Mobile-First, Secure Cloud-Based Point-of-Care Ultrasound Workflow Solution

03/18/2022

The device-agnostic software seamlessly integrates with hospital IT for streamlined documentation, billing and QA management all in one platform Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Exo (pronounced “echo”), a pioneering health information and devices company, has unveiled Exo Works™, an intelligent and intuitive point-of-care ultrasound workflow solution that enables physicians to easily document, review,…

Read More

HeartBeam Partners with Triple Ring Technologies to Co-Develop Telehealth Solution Device

03/18/2022

3D Vector ECG Collection Device Slated for FDA 510k Submission in the Fourth Quarter of 2022 Excerpt from the Press Release: SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology for heart attack detection, today announced it has signed a professional services agreement (the “Agreement”) with…

Read More

Avinger Announces Successful Completion of First Cases with the Lightbox 3 Next Generation Imaging Console

03/08/2022

Excerpt from the Press Release: REDWOOD CITY, CA / ACCESSWIRE / February 28, 2022 / Avinger, Inc. (NASDAQ:AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced that physicians in the U.S. have successfully completed first cases with its new…

Read More