medical devices Archives - MedCity News https://medcitynews.com/tag/medical-devices/ Healthcare technology news, life science current events Wed, 09 Aug 2023 18:48:19 +0000 en-US hourly 1 https://wordpress.org/?v=6.3.1 https://medcitynews.com/uploads/2021/03/cropped-mblue-32x32.png medical devices Archives - MedCity News https://medcitynews.com/tag/medical-devices/ 32 32 40682243 Newly Public Allurion Aims to Show How Med Tech Can Complement Obesity Drugs https://medcitynews.com/2023/08/weight-loss-obesity-medical-device-ai-software-allurion/ https://medcitynews.com/2023/08/weight-loss-obesity-medical-device-ai-software-allurion/#respond Wed, 02 Aug 2023 22:44:20 +0000 https://medcitynews.com/?p=643899

Allurion Technologies has commercialized a gastric balloon in the form of a pill that patients swallow. But the weight loss platform from the now NYSE-listed company also includes AI-driven software that provides insights about a patient’s progress, technology with the potential for use alongside obesity drugs.

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Rigorous Data Are Key to Convince Payers, Investors in the World of Digital Therapeutics https://medcitynews.com/2023/07/rigorous-data-are-key-to-convince-payers-investors-in-the-world-of-digital-therapeutics/ https://medcitynews.com/2023/07/rigorous-data-are-key-to-convince-payers-investors-in-the-world-of-digital-therapeutics/#respond Tue, 25 Jul 2023 22:06:56 +0000 https://medcitynews.com/?p=642378

Pear Therapeutics was once regarded as a digital therapeutics pioneer, but its spiral into bankruptcy has the industry searching for the best path forward. While some favor going direct to consumers, others say the solution is in generating more robust clinical trial data to persuade hesitant payers.

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FDA Authorizes Better Therapeutics Mobile App for Treating Type 2 Diabetes https://medcitynews.com/2023/07/fda-authorizes-better-therapeutics-mobile-app-for-treating-type-2-diabetes/ https://medcitynews.com/2023/07/fda-authorizes-better-therapeutics-mobile-app-for-treating-type-2-diabetes/#respond Tue, 11 Jul 2023 16:39:07 +0000 https://medcitynews.com/?p=641205 phone, text, texting, cell phone, smartphone

Better Therapeutics prescription digital therapeutic, AspyreRx, received De Novo FDA authorization for type 2 diabetes. The mobile app digitizes and personalizes cognitive behavioral therapy.

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How Medicare Coverage Diversifies Access to Innovation https://medcitynews.com/2023/06/how-medicare-coverage-diversifies-access-to-innovation/ https://medcitynews.com/2023/06/how-medicare-coverage-diversifies-access-to-innovation/#respond Thu, 08 Jun 2023 19:34:08 +0000 https://medcitynews.com/?p=635281

Appropriate Medicare reimbursement of high-intensity focused ultrasound for prostate disease is a significant development for the treatment for men 65 years and older today.

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Here’s a Preview of the Startups Pitching in the Medical Device Track at MedCity INVEST https://medcitynews.com/2023/05/medical-device-startups-medcity-invest/ https://medcitynews.com/2023/05/medical-device-startups-medcity-invest/#respond Tue, 09 May 2023 20:47:29 +0000 https://medcitynews.com/?p=633765

Finalists for the medical device track include an innovative, waterproof alterative to casts, a device geared to trauma care, an approach to improve early detection of lung cancer, cardiac monitoring medtech, and more. Register for the conference today!

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Pear Therapeutics’ Cuts Are Not Enough; ‘Strategic Alternatives’ Among Next Steps https://medcitynews.com/2023/03/pear-therapeutics-cuts-are-not-enough-strategic-alternatives-among-next-steps/ https://medcitynews.com/2023/03/pear-therapeutics-cuts-are-not-enough-strategic-alternatives-among-next-steps/#respond Sun, 19 Mar 2023 17:36:29 +0000 https://medcitynews.com/?p=627999

Pear Therapeutics isn’t meeting the commercialization goals for its prescription digital therapeutics, so it’s now seeking strategic alternatives for the business. Prospective buyers can pick up Pear’s FDA-cleared products for substance use disorder, opioid use disorder, and insomnia.

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Weight Loss in a Pill Device Firm Allurion Heads to NYSE via SPAC Merger https://medcitynews.com/2023/02/weight-loss-in-a-pill-device-firm-allurion-heads-to-nyse-via-spac-merger/ https://medcitynews.com/2023/02/weight-loss-in-a-pill-device-firm-allurion-heads-to-nyse-via-spac-merger/#respond Thu, 09 Feb 2023 23:45:13 +0000 https://medcitynews.com/?p=623737

Allurion Technologies has developed a gastric balloon that does not require surgery. The merger deal taking Allurion public comes as the company continues global commercialization of its technology.

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Apply to MedCity INVEST Pitch Perfect Where Investment Trends and Innovation Converge https://medcitynews.com/2023/02/investment-trends-and-innovation-medcity-invest-pitch-perfect/ https://medcitynews.com/2023/02/investment-trends-and-innovation-medcity-invest-pitch-perfect/#respond Thu, 09 Feb 2023 12:00:50 +0000 https://medcitynews.com/?p=623335 collaboration, partnership

In the runup to INVEST and the startup pitch contest, we highlight trends in investment and innovation across bipharma, diagnostics, medical devices, health tech: payer/provider, and health tech: consumer/employer. The deadline has been extended until February 28 and finalists will be announced March 31. Apply today!

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Time Is Running Out to Apply for MedCity’s Largest Pitch Contest of the Year https://medcitynews.com/2023/01/time-is-running-out-to-apply-for-medcitys-largest-pitch-contest-of-the-year/ https://medcitynews.com/2023/01/time-is-running-out-to-apply-for-medcitys-largest-pitch-contest-of-the-year/#respond Sat, 21 Jan 2023 12:30:20 +0000 https://medcitynews.com/?p=621337

With five tracks of startups across healthcare and life sciences, INVEST Pitch Perfect, scheduled for May 22-24 at the Ritz Carlton in Chicago, is MedCity’s largest startup pitch contest of the year. 

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Why Digital Health Collaborations Are the Future of Medtech [Sponsored] https://medcitynews.com/2022/11/why-digital-health-collaborations-are-the-future-of-medtech/ https://medcitynews.com/2022/11/why-digital-health-collaborations-are-the-future-of-medtech/#respond Thu, 03 Nov 2022 11:30:29 +0000 https://medcitynews.com/?p=611443

Executives from Huma, Abbott, Smith & Nephew and AliveCor share how they are using real world evidence collection to support remote patient monitoring, maximize patient engagement and navigate the regulatory landscape.

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How better ultrasound workflows can mitigate physician burnout https://medcitynews.com/2022/10/how-better-ultrasound-workflows-can-mitigate-physician-burnout/ https://medcitynews.com/2022/10/how-better-ultrasound-workflows-can-mitigate-physician-burnout/#respond Fri, 14 Oct 2022 12:15:48 +0000 https://medcitynews.com/?p=604042

By making documentation and images easily transferrable immediately after the imaging is performed, clinician workflow can be simplified. With modern point-of-care ultrasound workflows, healthcare providers can easily share patient information and provide optimal care.

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How medtech can crack the patient engagement conundrum and transform the patient experience [Sponsored] https://medcitynews.com/2022/10/how-medtech-can-crack-the-patient-engagement-conundrum-and-transform-the-patient-experience/ https://medcitynews.com/2022/10/how-medtech-can-crack-the-patient-engagement-conundrum-and-transform-the-patient-experience/#respond Tue, 11 Oct 2022 16:00:56 +0000 https://medcitynews.com/?p=606769 virtual care technology

A look at how tapping real world evidence from medical devices and patients could be a game changer, improving patient-clinician communication, supporting earlier interventions and helping patients manage their condition.

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FDA narrows EUAs for Covid-19 tests, steering companies to traditional review pathways https://medcitynews.com/2022/09/fda-narrows-euas-for-covid-19-tests-steering-companies-to-traditional-review-pathways/ https://medcitynews.com/2022/09/fda-narrows-euas-for-covid-19-tests-steering-companies-to-traditional-review-pathways/#respond Tue, 27 Sep 2022 20:32:09 +0000 https://medcitynews.com/?p=606142

The FDA said it will review fewer Covid-19 diagnostics for emergency use authorization. The policy update follows an Office of Inspector General report that found the urgency to increase testing availability led to problems, including the authorization of many low-quality tests.

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Weathering the good and the bad: Why good business practices work https://medcitynews.com/2022/08/weathering-the-good-and-the-bad-why-good-business-practices-work/ https://medcitynews.com/2022/08/weathering-the-good-and-the-bad-why-good-business-practices-work/#respond Fri, 05 Aug 2022 14:00:38 +0000 https://medcitynews.com/?p=593798

For most companies and medtech, in particular, good business practices (GBP) happens on multiple levels. On the micro level, it’s more prescriptive (i.e., regulatory best practices or good manufacturing practices). On the macro level, it’s expressed as a set of ethics and principles that govern a company’s conduct.

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Carrot Health founder launches SPV-only health tech VC fund https://medcitynews.com/2022/08/carrot-health-founder-launches-spv-only-health-tech-vc-fund/ https://medcitynews.com/2022/08/carrot-health-founder-launches-spv-only-health-tech-vc-fund/#respond Mon, 01 Aug 2022 22:34:48 +0000 https://medcitynews.com/?p=597743

Engage Venture Partners, a Minneapolis-based venture capital firm, recently launched with a focus on early stage medical tech companies. The firm was established to decrease friction between early stage medical tech companies and their investors by bringing its investments to market via special purpose vehicles (SPVs).

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Convergence of medtech and health tech: Helping providers plan procedures and easing patient anxiety [Sponsored] https://medcitynews.com/2022/06/convergence-of-medtech-and-health-tech-helping-providers-plan-procedures-and-easing-patient-anxiety/ https://medcitynews.com/2022/06/convergence-of-medtech-and-health-tech-helping-providers-plan-procedures-and-easing-patient-anxiety/#respond Mon, 27 Jun 2022 13:30:59 +0000 https://medcitynews.com/?p=590204

A pediatric health system enlisting mixed reality and 3D printing technology illustrates how clinical collaboration and patient education can improve patient outcomes for complex procedures.

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MedShift CEO shares vision for growth [Sponsored] https://medcitynews.com/2022/06/medshift-ceo-shares-vision-for-growth/ https://medcitynews.com/2022/06/medshift-ceo-shares-vision-for-growth/#respond Wed, 22 Jun 2022 15:21:27 +0000 https://medcitynews.com/?p=584658

A veteran of GE Healthcare, Joe Gasque talks about how he's growing the company's niche position in the high-paced aesthetics industry, offering services to surgeons, practitioners, medical device and injectables manufacturers.

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Skeptical of future performance, spooked by recent misses, Needham analyst downgrades Medtronic’s stock https://medcitynews.com/2022/05/skeptical-of-future-performance-spooked-by-recent-misses-needham-analyst-downgrades-medtronics-stock/ https://medcitynews.com/2022/05/skeptical-of-future-performance-spooked-by-recent-misses-needham-analyst-downgrades-medtronics-stock/#respond Fri, 27 May 2022 17:47:20 +0000 https://medcitynews.com/?p=589355 Down arrow

Mike Matson evaluated two earlier negative bits of information along with Thursday’s revenue and earnings-per-share miss to conclude that Medtronic’s stock, which has held up despite recent market swings, needs to be downgraded to a “hold” from a “buy”.

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Using AI to reduce false alerts for patients with heart monitoring devices to detect cardiac arrhythmias [Sponsored] https://medcitynews.com/2022/05/_using_ai_reduce_falsealerts_for_patients/ https://medcitynews.com/2022/05/_using_ai_reduce_falsealerts_for_patients/#respond Thu, 26 May 2022 11:30:41 +0000 https://medcitynews.com/?p=585498

An infographic illustrates how Medtronic’s AccuRhythm AI suppresses false alerts while maintaining sensitivity.

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With the FTC’s conditional approval, Medtronic completes its $1.1B acquisition of Intersect ENT https://medcitynews.com/2022/05/with-ftcs-conditional-approval-medtronic-completes-its-1-1b-acquisition-of-intersect-ent/ https://medcitynews.com/2022/05/with-ftcs-conditional-approval-medtronic-completes-its-1-1b-acquisition-of-intersect-ent/#respond Fri, 13 May 2022 17:16:52 +0000 https://medcitynews.com/?p=587330

To get approval for the deal, Medtronic agreed to sell an Intersect subsidiary to soothe the FTC’s concerns.

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Biofourmis adds $300M to ramp up in virtual care, digital therapy clinical trials https://medcitynews.com/2022/04/biofourmis-adds-300m-to-ramp-up-in-virtual-care-digital-therapy-clinical-trials/ https://medcitynews.com/2022/04/biofourmis-adds-300m-to-ramp-up-in-virtual-care-digital-therapy-clinical-trials/#respond Tue, 26 Apr 2022 15:32:27 +0000 https://medcitynews.com/?p=584517

The Series D round of funding makes Biofourmis a unicorn valued at $1.3 billion. CEO and founder Kuldeep Singh Rajput said that the new capital will be used to expand his company’s remote-monitoring technologies and continue development of digital therapeutics, both as companions to traditional drugs and as monotherapies.

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3D printers have proved their value to hospitals for limb-saving surgery, Covid-19 supply chain issues, and more [Sponsored] https://medcitynews.com/2022/04/3d-printers-limb-saving-surgery-covid-19-supply-chain-issues/ https://medcitynews.com/2022/04/3d-printers-limb-saving-surgery-covid-19-supply-chain-issues/#respond Tue, 12 Apr 2022 14:18:15 +0000 https://medcitynews.com/?p=581958

A recent webinar sponsored by Formlabs underscored the value of 3D printing from a clinical perspective and offered insight on how commercial and regulatory players are thinking about this space.

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Becton Dickinson spins off diabetes biz, enabling Embecta to embark on its own https://medcitynews.com/2022/04/becton-dickinson-spins-off-diabetes-biz-enabling-embecta-to-embark-on-its-own/ https://medcitynews.com/2022/04/becton-dickinson-spins-off-diabetes-biz-enabling-embecta-to-embark-on-its-own/#respond Fri, 01 Apr 2022 17:03:51 +0000 https://medcitynews.com/?p=581043

The second quarter of 2022 kicked off with a new life sciences company joining the public markets, but not via an IPO or merger. Becton Dickinson on Friday completed the spinoff of its diabetes care business, Embecta, which now trades on the Nasdaq.

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3D Printed medical devices for precision surgery [Sponsored] https://medcitynews.com/2022/03/3d-printed-medical-devices-for-precision-surgery/ https://medcitynews.com/2022/03/3d-printed-medical-devices-for-precision-surgery/#respond Fri, 11 Mar 2022 12:30:21 +0000 https://medcitynews.com/?p=573600

Formlabs is sponsoring a webinar exploring 3D printing from clinical, commercial, and regulatory perspectives.

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Bausch + Lomb’s IPO plans come into focus as BHC prepares to split into three https://medcitynews.com/2022/01/bausch-lombs-ipo-plans-come-into-focus-as-bhc-prepares-to-split-into-three/ https://medcitynews.com/2022/01/bausch-lombs-ipo-plans-come-into-focus-as-bhc-prepares-to-split-into-three/#respond Fri, 14 Jan 2022 21:19:34 +0000 https://medcitynews.com/?p=566155

Bausch + Lomb is returning to the public markets in an IPO expected to rank among the biggest in healthcare. Speaking at the annual J.P. Morgan Healthcare Conference, Bausch Health Companies CEO Joe Papa discussed the plans to spin off both the iconic eye products business as well as the skin products business, leaving three independent and publicly traded companies.

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The new season of surgery evolution [Sponsored] https://medcitynews.com/2022/01/surgery-evolution/ https://medcitynews.com/2022/01/surgery-evolution/#respond Fri, 14 Jan 2022 12:30:07 +0000 https://medcitynews.com/?p=565948

We are building upon the foundation of digital laparoscopy and adding machine vision, augmented intelligence, and deep learning capabilities.

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BrightInsight CEO Kal Patel M.D. discusses the future of regulated digital health for biopharma and medtech  [Sponsored] https://medcitynews.com/2022/01/brightinsight-ceo-kal-patel-m-d-discusses-the-future-of-regulated-digital-health-for-biopharma-and-medtech/ https://medcitynews.com/2022/01/brightinsight-ceo-kal-patel-m-d-discusses-the-future-of-regulated-digital-health-for-biopharma-and-medtech/#respond Tue, 04 Jan 2022 14:15:11 +0000 https://medcitynews.com/?p=564029

In order to benefit from the Virtual1Care trend, pharma and medtech companies must ensure that their digital health tools, wrapped around a drug or device, comply with evolving regulations.

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GE Healthcare closes $1.45B acquisition of BK Medical https://medcitynews.com/2021/12/ge-healthcare-closes-1-45b-acquisition-of-bk-medical/ https://medcitynews.com/2021/12/ge-healthcare-closes-1-45b-acquisition-of-bk-medical/#respond Tue, 21 Dec 2021 18:00:31 +0000 https://medcitynews.com/?p=563147 Give and take concept on black background

The company would become part of GE’s ultrasound business, expanding its capabilities to include surgical visualization. GE plans to spin out its healthcare division into a publicly traded company in 2023. 

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Eli Lilly joins Verge Genomics’ $98M round as AI-discovered ALS drug nears clinic https://medcitynews.com/2021/12/eli-lilly-joins-verge-genomics-98m-round-as-ai-discovered-als-drug-nears-clinic/ https://medcitynews.com/2021/12/eli-lilly-joins-verge-genomics-98m-round-as-ai-discovered-als-drug-nears-clinic/#respond Thu, 16 Dec 2021 20:34:02 +0000 https://medcitynews.com/?p=562559

Three life science companies unveiled Series B rounds of funding Thursday, early Christmas gifts that top $219 million combined. Along with Verge Genomics, the other companies that raised new capital are Tasso and Brainomix.

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CMS scraps coverage rule for breakthrough devices https://medcitynews.com/2021/11/cms-scraps-coverage-rule-for-breakthrough-devices/ https://medcitynews.com/2021/11/cms-scraps-coverage-rule-for-breakthrough-devices/#respond Fri, 12 Nov 2021 19:34:32 +0000 https://medcitynews.com/?p=558353 Medicare for all, single payer

The agency decided to rescind a rule by the previous administration where Medicare would be required to cover breakthrough devices for up to four years after they receive FDA approval or clearance. CMS said it made the change to address safety concerns with the policy.

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