medical device Coverage - MedCity News https://medcitynews.com/tag/medical-device/ Healthcare technology news, life science current events Wed, 12 Jun 2024 06:30:27 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 228111745 From Recalls to Reliability: Tools to Ensure Software Safety in MedTech https://medcitynews.com/2024/06/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech/ https://medcitynews.com/2024/06/from-recalls-to-reliability-tools-to-ensure-software-safety-in-medtech/#respond Fri, 14 Jun 2024 13:28:00 +0000 https://medcitynews.com/?p=126866

Cutting-edge technology empowers developers to proactively detect and mitigate issues before they cause problems, reducing recalls and fostering trust in the industry.

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A Wearable Tech Gives Pharmas & Therapists Better Feel for Changes in Mental Health https://medcitynews.com/2024/04/wearable-tech-feel-therapeutics-mental-health-clinical-trials/ https://medcitynews.com/2024/04/wearable-tech-feel-therapeutics-mental-health-clinical-trials/#respond Sun, 14 Apr 2024 12:30:00 +0000 https://medcitynews.com/?p=125014

Pharmaceutical companies use Feel Therapeutics’ technology to monitor the mental state of participants in clinical trials of behavioral medications. But the startup envisions its technology eventually also finding a place as a part of clinical care.

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Novocure’s Electrical Cancer Therapy Shows It Can Treat Tumors in the Brain https://medcitynews.com/2024/03/electricity-cancer-therapy-metastases-tumor-novocure/ Wed, 27 Mar 2024 21:51:09 +0000 https://medcitynews.com/?p=668682

Novocure said its “Tumor Treating Fields” met the main goal of a pivotal study enrolling non-small cell lung cancer patients with brain metastases. However, results for the electricty-based treatment fell short of statistical significance on several secondary endpoints.

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Metabolic Disorder-Focused Fractyl Health ‘GUTS’ Out a $110 Million IPO https://medcitynews.com/2024/02/metabolic-disorder-biotech-ipo-medical-device-obesity-fractyl-health/ Fri, 02 Feb 2024 18:18:28 +0000 https://medcitynews.com/?p=663213

Fractyl Health will use the IPO proceeds for pivotal testing of a medical device and surgical procedure intended to address root causes of diabetes and obesity. The Fractyl pipeline also includes a gene therapy for these conditions.

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Boston Scientific Continues Buying Spree with $3.7B Axonics Acquisition https://medcitynews.com/2024/01/boston-scientific-axonics-medical-device-jpm/ Mon, 08 Jan 2024 20:28:34 +0000 https://medcitynews.com/?p=660594

Medical device giant Boston Scientific added to its string of recent acquisitions by announcing its plan to buy Axonics, a maker of neurostimulation devices that treat urinary and bowel dysfunction, for $3.7 billion. Experts agree that this deal will make a profitable impact on Boston Scientific’s urology business.

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Why Abbott Believes Its New Pacemaker Will Help It Capture More Market Share https://medcitynews.com/2023/11/abbott-cardiac-pacemaker-healthcare-heart/ Fri, 17 Nov 2023 20:10:42 +0000 https://medcitynews.com/?p=655848

Abbott’s new leadless pacemaker system has become commercially available and has begun being implanted in people at hospitals across the nation. Most people who need a pacemaker require pacing in two chambers of the heart, and the dual-chamber technology in Abbott’s new system allows these patients to have a leadless pacemaker.

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Exo Is On a Mission to Put an Ultrasound Machine In Every Care Provider’s Pocket https://medcitynews.com/2023/10/ultrasound-healthcare-technology/ Thu, 19 Oct 2023 23:26:58 +0000 https://medcitynews.com/?p=652566

With its new handheld ultrasound device, Exo is seeking to take point-of-care ultrasound beyond just the emergency medicine field — into areas like urgent care, primary care and the home. Kurt Hammond, Exo’s chief commercial officer, said that the device sets itself apart from other handheld ultrasound devices, such as those sold by GE, Philips and Butterfly Network, because its AI does a better job of making the ultrasound process quick and easy for providers.

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Twice Rejected Diabetes Drug/Device Product Gets New Chance at Startup i2o https://medcitynews.com/2023/09/twice-rejected-diabetes-drug-device-product-gets-new-chance-at-startup-i2o/ Mon, 04 Sep 2023 18:04:18 +0000 https://medcitynews.com/?p=647505

Intarcia Therapeutics’ GLP-1 agonist product candidate for type 2 diabetes now belongs to i2o Therapeutics, which will make the treatment’s case for approval at an upcoming FDA advisory committee meeting. The startup’s $46 million Series A financing is one of several recently announced funding rounds.

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New Israeli Health Tech Fund Launches to Invest in Pre-Seed and Seed-Stage Startups https://medcitynews.com/2023/06/venture-fund-investment-digital-health-medical-device-israel/ Thu, 29 Jun 2023 22:02:10 +0000 https://medcitynews.com/?p=639975

Israeli health tech fund Shoni Health Ventures recently launched to invest in digital health and medical device startups that are in the pre-seed and seed stages of fundraising. The fund is affiliated with Sheba Medical Center, the largest hospital in Israel. Startups will have access to the hospital’s innovation center so that they can develop, pilot and commercialize their products.

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Cala Health Launches Wearable Device to Treat Hand Tremors https://medcitynews.com/2023/06/essential-tremor-parkinsons-wearable-healthcare-medical-device/ Wed, 14 Jun 2023 19:15:10 +0000 https://medcitynews.com/?p=638235

Cala Health recently launched its kIQ system — which it calls the first noninvasive wearable device cleared by the FDA to temporarily relieve tremors in people with essential tremor and Parkinson’s disease.

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Meet the Company Building the First-Ever Noninvasive Blood Glucose Monitoring Device https://medcitynews.com/2023/06/diabetes-medical-device-blood-glucosse-monitoring-healthcare/ Sun, 11 Jun 2023 14:10:51 +0000 https://medcitynews.com/?p=637741

Know Labs recently unveiled the prototype for its non-invasive, portable glucose monitoring device. The device incorporates the company’s proprietary body-radio frequency identification (Bio-RFID) technology — meaning its sensors deploy radio waves that travel through the skin to find and measure molecular signatures in the blood.

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Mobility Device Startup Founder Focuses on People Who Need Support to Walk https://medcitynews.com/2023/05/mobility-device-startup-founder-focuses-on-people-who-need-support-to-walk/ Wed, 24 May 2023 15:45:54 +0000 https://medcitynews.com/?p=635719

Robert Lewis is the founder of Freedom to Roam, a medical device company seeking to help people with mobility challenges.

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Magenta Medical Rakes In $55M for ‘World’s Smallest Heart Pump’ https://medcitynews.com/2023/05/heart-pump-cardiology-medical-device/ Wed, 03 May 2023 17:17:12 +0000 https://medcitynews.com/?p=633453

Israeli medical device developer Magenta Medical recently closed a $55 million financing round. The new funding will be used primarily to help Magenta attain FDA approval for its flagship product — a percutaneous left ventricular assist device called Elevate.

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Patient Square Capital Launches Company to Support Medical Device Startups https://medcitynews.com/2023/05/medical-device-startups-capital-funding-investment/ Mon, 01 May 2023 18:05:48 +0000 https://medcitynews.com/?p=633093

Healthcare investment firm Patient Square Capital launched a new portfolio company: Elevage Medical Technologies. The company will support growth-stage medical device companies by providing capital, as well as operational and clinical expertise — it received an initial investment of $300 million from Patient Square.

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3 Key Areas Where Modern Technologies are Accelerating Medtech https://medcitynews.com/2023/04/3-key-areas-where-modern-technologies-are-accelerating-medtech/ Wed, 05 Apr 2023 22:51:10 +0000 https://medcitynews.com/?p=628290

Consumers are demanding the constant need for technology that is simple, connected and convenient, and medtech companies have had to accelerate to meet those needs. They are embracing these changing times and using it as an opportunity to innovate in three key areas.

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Nvidia, Medtronic Partner to Create AI Platform for Medical Devices https://medcitynews.com/2023/03/nvidia-medtronic-partner-to-create-ai-platform-for-medical-devices/ Tue, 21 Mar 2023 23:18:02 +0000 https://medcitynews.com/?p=628428

Nvidia and Medtronic recently announced a collaboration focused on embedding AI into medical devices. The two companies plan to create marketplace for AI applications that will allow developers and clinicians to develop their own algorithms to use on Medtronic’s medical devices.

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Miach Orthopaedics Snags $40M to Change the Standard of Care for ACL Tears https://medcitynews.com/2023/01/miach-orthopaedics-snags-40m-to-change-the-standard-of-care-for-acl-tears/ Thu, 26 Jan 2023 22:54:02 +0000 https://medcitynews.com/?p=622081

Miach Orthopaedics — a medical device company focused on restoring torn ACLs instead of reconstructing them — recently received $40 million in funding. The capital will be used to expand the U.S. commercial rollout of the company’s implantable device, which received FDA de novo clearance in 2020.

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AstraZeneca, Avillion Land FDA Approval for First of Its Kind Asthma Inhaler https://medcitynews.com/2023/01/astrazeneca-avillion-land-fda-approval-for-first-of-its-kind-asthma-inhaler/ Wed, 11 Jan 2023 19:12:34 +0000 https://medcitynews.com/?p=620119

The FDA approved Airsupra, an asthma rescue inhaler that administers two different medications, one that opens up airways and another that treats inflammation. The inhaler stems from a partnership between AstraZeneca and Avillion.

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Tumor-Zapping Device Scores in Pivotal Study, Sends Shares of Novocure Soaring https://medcitynews.com/2023/01/tumor-zapping-device-scores-in-pivotal-study-sends-shares-of-novocure-soaring/ Thu, 05 Jan 2023 22:35:31 +0000 https://medcitynews.com/?p=619420

Novocure’s electrical field-producing medical device, in combination with standard drug therapies, improved overall survival in a pivotal study that enrolled patients with advanced non-small cell lung cancer. The medtech company now plans to seek regulatory approvals.

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Withings Unveils Urine Analysis Device That Sits in Your Toilet Bowl https://medcitynews.com/2023/01/withings-unveils-urine-analysis-device-that-sits-in-your-toilet-bowl/ Wed, 04 Jan 2023 01:01:34 +0000 https://medcitynews.com/?p=619129

Withings announced that it is developing a miniaturized platform that can analyze urine at home. The device, called U-Scan, sits within a toilet bowl and assesses specific biomarkers found in urine.

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Google Partners with iCAD, Licenses Its Mammography AI Model for the First Time https://medcitynews.com/2022/11/google-partners-with-icad-licenses-its-mammography-ai-model-for-the-first-time/ Wed, 30 Nov 2022 22:57:18 +0000 https://medcitynews.com/?p=615508

Medical device manufacturer iCAD entered into a development and commercialization agreement with Google Health, in which it will integrate Google’s mammography AI technology into its suite of breast imaging AI products. The agreement marks Google’s first commercial partnership to deploy its breast imaging AI model into clinical practice.

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IU Health Taps TRIMEDX to Help Combat Cyber Threats at Medical Device Security Lab https://medcitynews.com/2022/11/iu-health-trimedx-combat-cyber-threats-medical-device-security-lab/ Tue, 01 Nov 2022 20:35:35 +0000 https://medcitynews.com/?p=611266

Indiana University Health has begun working with healthcare technology company TRIMEDX to test the security of connected medical devices at the health system’s medical device security lab. At the lab, IU Health and TRIMEDX will focus on testing new devices, configurations and security settings, as well as actively scanning medical equipment for security vulnerabilities.

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INVEST Pitch Perfect winner: BeCare Link brings MS assessments to patients’ homes https://medcitynews.com/2022/08/invest-pitch-perfect-winner-becare-link-brings-ms-assessments-to-patients-homes/ Thu, 25 Aug 2022 12:30:11 +0000 https://medcitynews.com/?p=601468

BeCare Link has developed software that enables the traditional in-person multiple sclerosis assessment to be done remotely on a patient’s own mobile device. The startup was named the winner of MedCity’s recent Pitch Perfect contest.

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Materna Medical raises $22M to heal women’s pelvic floors https://medcitynews.com/2022/08/materna-medical-raises-22m-to-heal-womens-pelvic-floors/ Fri, 12 Aug 2022 17:39:22 +0000 https://medcitynews.com/?p=599504

Materna Medical, a company that sells Ob-gyn medical devices, recently raised $22 million in Series B funding. The round was raised by CEO Tracy MacNeal, which stands out because female founders raised just 2% of all venture capital money last year.

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Pear Therapeutics pares down its plans as restructuring cuts 9% of workforce https://medcitynews.com/2022/07/pear-therapeutics-pares-down-its-plans-as-restructuring-cuts-9-of-workforce/ Tue, 26 Jul 2022 22:25:12 +0000 https://medcitynews.com/?p=597086

Pear Therapeutics is implementing a corporate restructuring projected to save about $28 million. The goal is to extend its available cash as the company presses on with commercialization efforts for its digital therapeutics.

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INVEST Pitch Perfect winner: Modality.ai makes Tina the Alexa of clinical trials https://medcitynews.com/2022/05/invest-pitch-perfect-winner-modality-ai-makes-tina-the-alexa-of-clinical-trials/ Wed, 18 May 2022 11:30:55 +0000 https://medcitynews.com/?p=587924

Modality.ai has developed a conversational AI system that replaces in-person interviews that are part of neurological assessments for a range of disorders. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.

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GE Healthcare announces partnership with AliveCor, launches new digital platform at HIMSS https://medcitynews.com/2022/03/ge-healthcare-announces-partnership-with-alivecor-launches-new-digital-platform-at-himss/ Thu, 17 Mar 2022 22:28:25 +0000 https://medcitynews.com/?p=577917

With its two major announcements at the Global Health Conference & Exhibition in Orlando, the company signaled it is aiming to help providers access more in-depth, real-time patient data to improve clinical decision-making and care.

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INVEST Pitch Perfect winner spotlight: Strados Labs and its ‘Holter for the lungs’ https://medcitynews.com/2021/10/invest-pitch-perfect-winner-spotlight-strados-labs-and-its-holter-for-the-lungs/ Mon, 25 Oct 2021 17:04:24 +0000 https://medcitynews.com/?p=555455

Strados Labs has developed a wearable device that senses lung sounds in patients with asthma, COPD, and other respiratory disorders. The startup, which has FDA clearance and a growing list of customers, was judged the winner in the Pitch Perfect competition at MedCity News’ recent INVEST Digital Health conference.

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INVEST Precision Medicine winner spotlight: Nia Therapeutics https://medcitynews.com/2021/07/invest-precision-medicine-winner-spotlight-nia-therapeutics/ Fri, 16 Jul 2021 15:57:17 +0000 https://medcitynews.com/?p=540488

The FDA has yet to approve a therapy for memory loss. Nia Therapeutics is developing a medical device that stimulates the brain to bring it back to a “good memory state,” and it was judged the winner in the life sciences track of the INVEST Precision Medicine Pitch Perfect Competition.

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FDA authorizes machine learning software to help diagnose autism https://medcitynews.com/2021/06/fda-authorizes-machine-learning-software-to-help-diagnose-autism/ Fri, 04 Jun 2021 23:12:15 +0000 https://medcitynews.com/?p=533948

The system, developed by digital health startup Cognoa, uses information from questionnaires and videos to help pediatricians diagnose autism. It received marketing authorization from the FDA on Wednesday.

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