Medical Devices

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


– 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


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


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


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


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


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

AI-Powered Algorithm Gets FDA 501(k) Clearance for Detection of Subarachnoid Hemorrhages


A recent study found that Viz ANEURYSM had a 94 percent accuracy rate of diagnosing subarachnoid hemorrhages on computed tomography angiography (CTA). Excerpt from the Press Release: Subarachnoid hemorrhages reportedly affect nearly 30,000 Americans each year and have a 40 percent mortality rate. However, Viz ANEURYSM, a new artificial intelligence (AI)-powered algorithm, may improve the…

Read More

Ra Medical Systems Provides an Update on Enrollment in Its Pivotal Atherectomy Clinical Trial


Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Ra Medical Systems, Inc. (NYSE American: RMED), a medical device company focused on developing its excimer laser system to treat vascular diseases, announces enrollment has reached 95 subjects in its pivotal clinical trial to evaluate the safety and effectiveness of the DABRA excimer laser system as an atherectomy…

Read More

Theradaptive Wins Additional FDA Breakthrough Designation for Spinal Fusion


Excerpt from the Press Release: FREDERICK, Md. and BOSTON, Feb. 15, 2022 /PRNewswire/ — Theradaptive, a privately held biopharmaceutical company pioneering a new class of regenerative implants announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Medical Device designation for its OsteoAdapt SP Spinal Fusion implant indicated for posterolateral spinal fusion to treat degenerative disc disease, spondylolisthesis,…

Read More

atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial


Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design Excerpt from the Press Release: BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start…

Read More