Medical Devices

First Patients Enrolled in Pivotal Study Evaluating HeartBeam’s AIMIGo™ System for Synthesizing a 12-Lead ECG


VALID-ECG Study will Form the Basis of the Company’s Upcoming FDA 510(k) Submission Excerpt from the Press Release: SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, announced today that it has enrolled the first patients in the VALID-ECG (Clinical Validation of…

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SOPHiA GENETICS and The French Kidney Cancer Research Network (UroCCR) Publish Results from Multiyear Collaboration


New Multimodal Algorithm Highlights Predictive Benefit Of Artificial Intelligence (AI) for Cancer Research Excerpt from the Press Release: BOSTON and ROLLE, Switzerland, March 15, 2024 /PRNewswire/ — SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native software company and a leader in data-driven medicine, and the French Kidney Cancer Research Network (UroCCR) collaborated on a study using a multimodal…

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1nhaler Raises £2 Million to Develop Single-Use Sustainable Inhaler


Excerpt from the Press Release: Inhalable medicines are already widely used to treat conditions such as asthma, epilepsy, allergies and Parkinson’s but, to date, delivery options have been limited due to user accessibility, cost, performance and impact on the environment. 1nhaler has developed a way of enabling many different dry powder drugs to be readily…

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Recor Medical Announces Positive Results from Six-Month Pooled Analysis of Data from the RADIANCE Global Clinical Trial Program at TCT 2023


Analysis shows a maintained blood pressure lowering effect with fewer added medications following treatment with the Paradise Ultrasound Renal Denervation system Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”), today announced positive results from a combined analysis of six-month…

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RAPT Therapeutics to Present Biomarker Data Corroborating Demonstrated Clinical Activity and Mechanism of Action of FLX475 in Advanced Cancers


-FLX475-treated patients exhibited significant changes in immune pathways likely to enhance an antitumor response -FLX475 modifies the tumor microenvironment (TME) to resemble those of responders to anti-PD(L)1 monotherapy Excerpt from the Press Release: RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients…

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JACC Publication Guides Use of CareDx’s HeartCare Transplant Rejection Surveillance in Clinical Practice


Guide Helps Transplant Centers Continue the Evolution from Endomyocardial Biopsies to Noninvasive Surveillance Using AlloMap GEP and AlloSure dd-cfDNA Excerpt from the Press Release: BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that…

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IntraOp and Vanderbilt University Medical Center Announce First Patient Treated for Pancreatic Cancer Using Intra-Operative Radiation Therapy With Electrons


IntraOp MobetronProves An Effective Tool In This First-Time Pancreatic Treatment at VUMC Excerpt from the Press Release: SUNNYVALE, Calif.–(BUSINESS WIRE)–IntraOp Medical Corporation announced today that doctors at Vanderbilt University Medical Center (VUMC) treated a pancreatic cancer patient using IntraOp® Mobetron® Intra-Operative Radiation Therapy (IORT). Based in Nashville, Tennessee, and serving the southeast region of the…

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Frontier Medicines Advances First Development Candidate, FMC-376, a Uniquely Differentiated Inhibitor of Both Active and Inactive KRASG12C, into IND-Enabling Studies


FMC-376 directly, rapidly, and completely blocks both active and inactive forms of KRASG12C to overcome non-response and resistance seen with prior generation KRASG12C inhibitors The company has also advanced two additional precision oncology programs against historically undruggable disease-causing targets into lead optimization Pamela Klein, M.D., seasoned oncology drug developer, elected to board of directors Excerpt…

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Madrigal Announces Additional Positive Results from the Pivotal Phase 3 MAESTRO-NASH Clinical Trial of Resmetirom for the Treatment of NASH with Liver Fibrosis


As previously reported, resmetirom demonstrated improvements in NASH and liver fibrosis on liver biopsies, the primary endpoints of the MAESTRO-NASH trialA supportive analysis using consensus reads of digitized biopsy images by the central pathologists replicated the positive primary endpoint resultsThese data will be presented at the NASH-TAG Conference on Friday January 6th, 2023 Excerpt from…

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Helius Extends its Patient Therapy Access Program (PTAP), Bringing the Benefits of its PoNS® Device to More People with Multiple Sclerosis


Excerpt from the Press Release: PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans NEWTOWN, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies (NASDAQ: HSDT) today announced the extension of a program that puts the company’s Portable Neuromodulation Stimulator (PoNS®) into the hands of qualified Americans with multiple sclerosis (MS) at a…

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