Medical Device News Magazine
Wednesday, January 8, 2025

Florida / New York

Medical Device News Magazine

What are the future trends of medical devices?  In the rapidly evolving landscape of healthcare, staying informed about the latest advancements in medical technology is essential for professionals and enthusiasts alike. This publication serves as a vital resource, offering insights into cutting-edge innovations, regulatory developments, FDA medical device news, and other industry trends that impact both patient care and business strategies. We aim to bridge the gap between healthcare professionals, investors, and the medical device industry, providing a comprehensive platform of medical device news that can result in discussions on medical device/biotechnology advancements and their implications for the future of medicine.

Read this medtech magazine as we explore the intersection of technology and healthcare, facilitating informed decision-making and fostering collaboration within this dynamic field. Inquire about advertising. Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc.

AI Hype vs. Reality: Medical Billing’s Need for Human Expertise | By John T Bright, CEO & Founder at Med Claims Compliance Corporation (MCC)

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The U.S. healthcare system is under mounting financial pressure, driven by the abrupt rise to 55.7% in Medicare Advantage claims denials, reached between 2022 and 2023. This surge exacerbates an already costly issue: medical billing errors that drain billions annually. These errors not only strain healthcare providers but also delay reimbursements, increase administrative burdens, and ultimately affect patient care. The financial impact of denied claims and coding errors extends beyond providers; patients also suffer due to delays or unexpected out-of-pocket expenses. Compounding the challenge is a 30% shortage of medical coders, leaving organizations vulnerable to inaccuracies and backlogs in processing claims. In this complex landscape, the need for innovative, scalable solutions has never been more urgent.

View from our Experts

Executives on the Move

Paul Ziegler Appointed President and CEO of Augmedics

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“I am thrilled to join the Augmedics team and build on the foundation they’ve established as the leading spine-based AR platform on the market,” said Paul Ziegler. “I am excited and honored to lead the company through this next phase of growth as we capitalize on the game-changing potential of xvision to make spine surgery safer, simpler, and more reproducible.”

Nusano Names Medical Radioisotopes Advisory Board

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“As a radioisotope producer, Nusano plays a critical role in the supply chains of drug developers, healthcare providers and researchers,” said Chris Lowe, CEO of Nusano. “Establishing a Medical Radioisotopes Advisory Board reflects our ongoing commitment to proactively enabling the next generation of oncology research. The board’s guidance will ensure Nusano is providing a stable and scalable supply of isotopes for new areas of research and patient care.”

Jason Whiting Appointed CEO of Avation Medical

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Jason Whiting has more than 25 years of experience in the MedTech industry, driving innovation and adoption of new technologies in the implantable, capital equipment, and wearable markets.

Jay Hallinan Appointed Chief Commercial Officer of Q’Apel Medical

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Jay Hallinan will lead the company's global sales and marketing organization, oversee Q'Apel's commercial strategy and drive revenue growth across Q'Apel's expanding product portfolio.

Robert Guigley Is Appointed Chief Commercial Officer of DELFI Diagnostics

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Robert Guigley most recently served as the Chief Commercial Officer at Invitae, where he orchestrated a commercial reorganization to transition from a growth-centric to a sustainable profit model.

Darrin T Schellin Becomes the New CEO at Pharma Tech Industries

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Pharma Tech Industries, a leading global provider of contract...

Mark Gaffney Is Appointed CEO of Calluna Pharma | Mark Altmeyer as Independent Chair of the Board

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Mark Gaffney brings over 20 years of experience in corporate strategy, business development, and operations in both private and public biotechnology companies, and will lead the team that defines and executes on the corporate strategy, particularly as its lead program is on pace to complete its Phase 1 program later this year. 

John Beeler Appointed SVP of Business Development at BPGbio

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Dr. John Beeler is a seasoned biopharma executive with extensive experience in growing innovative companies, will lead BPGbio’s business development team in securing licensing and commercial partnership opportunities for BPGbio’s NAi Interrogative Biology platform and its extensive pipeline of AI-developed therapeutic candidates.

Christopher Whitmore Appointed CFO at Ray Therapeutics

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Christopher Whitmore is a highly accomplished executive who brings over 20 years of strategic finance, accounting, and operational expertise. His deep experience spans from early-stage biotech to publicly-traded companies, with a focus on both private and public capital raising.

Andy Fuller Appointed VP of Market Access at AESAR

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With over 27 years of experience in the pharmaceutical industry, Andy Fuller brings extensive expertise in developing and executing go-to-market and payer engagement strategies across highly competitive markets.

Medtronic Hires Dr James Porter, One of the Nation’s Top Surgeons as CMO

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A practicing urologic surgeon who has performed more than 5,000 robotic-assisted procedures, Dr James Porter is a recognized leader among the global surgical community and one of the top five robotic surgery practitioners in the U.S. 

Luba Greenwood Is Appointed Chair of the Board of Directors of Closed Loop Medicine

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Luba Greenwood is a distinguished executive and investor with over 20 years’ experience in healthcare and tech. She has led over $10 billion USD in deals and investment over multiple therapeutic areas, leading success and scaling companies across the life sciences, medical devices, diagnostics, and tech sectors, including co-founding biotech and digital companies in the immunotherapy, women’s health, AI/ML and microbiome space.

Featuring

Luna Partners with Leading Academic Medical Center | To Expand Access to In-home, Outpatient PT Services

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Luna advises the new collaboration will start taking appointments in February 2025, and patients seeking care will receive safe, high-quality PT conveniently delivered to their homes.

Philips and AWS Expand Strategic Collaboration to Advance HealthSuite Cloud Services and Power Generative AI Workflows

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“The collaboration between Philips and AWS gives healthcare providers scalable, secure-by-design cloud-enabled solutions to accelerate healthcare innovation,” said Matt Garman, CEO of AWS. “Combining Philips’ healthcare informatics portfolio with AWS generative AI capabilities gives clinicians access to imaging insights so they can deliver more effective and efficient care to patients anywhere, anytime, with best-in-class security and privacy.”

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

MEDICAL DEVICES, TECHNOLOGIES, EQUIPMENT, SUPPLIES 0
Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

MEDICAL DEVICES, TECHNOLOGIES, EQUIPMENT, SUPPLIES 0
Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

MEDICAL DEVICES, TECHNOLOGIES, EQUIPMENT, SUPPLIES 0
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

MEDICAL DEVICES, TECHNOLOGIES, EQUIPMENT, SUPPLIES 0
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Elucid Announces Fifth Medicare Administrative Contractor to Cover AI Coronary Plaque Analysis

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“This latest expansion of coverage by Noridian means that even more patients could be positively impacted by PlaqueIQ, which offers the only non-invasive measurement of lipid-rich necrotic core, a vulnerable, high-risk component of plaque that can lead to heart attack and stroke,”4 said Kelly Huang, CEO of Elucid. “These recent decisions from five of the seven MACs recognize the importance of new technologies like ours that can help quantify and classify coronary artery plaque to help physicians reduce the clinical and economic burden of cardiovascular disease.”
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Hospitals in the News

Smart Hospitals: Redefining Global Healthcare with Digital Innovation

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Smart hospitals are at the forefront of a global transformation in healthcare, integrating advanced technologies to improve patient outcomes, enhance operational efficiency, and reduce costs.

The Northwell Health Constellation Gala Raises More Than $3.2M To Support Health Care Innovation In Manhattan

HOSPITALS 0
This year’s event was hosted by actress and comedian Cecily Strong and featured a musical performance by the Orchestra of St. Luke’s. Proceeds will provide greater access to high-quality care by helping to advance services and programs across Manhattan at Lenox Hill Hospital, Manhattan Eye, Ear & Throat Hospital, Lenox Health Greenwich Village  – and soon, the Victoria and Lloyd Goldman Health Care Pavilion, a state-of-the-art outpatient care facility that is slated to open on the Upper East Side in 2026.
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Mergers / Acquisitions

Poseida Therapeutics Announces Agreement to be Acquired by Roche Holdings, Inc.

ACQUISITIONS and MERGERS 0
The proposed acquisition will establish a new core capability for Roche in allogeneic cell therapy, with lead opportunities focused on CAR-T programs covered by the existing strategic collaboration between Poseida and Roche in hematologic malignancies. It will include CAR-T programs for solid tumors and autoimmune diseases, along with Poseida's genetic engineering platform and related preclinical medicines.

Boston Scientific Closes Acquisition of Axonics

ACQUISITIONS and MERGERS 0
Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. “By closing this acquisition, we’re pleased to welcome the Axonics team into Boston Scientific. The addition of the Axonics product portfolio enables us to expand into sacral neuromodulation, a high-growth adjacency for our Urology business, while bringing a comprehensive portfolio of products to patients around the world who are seeking tailored treatment options based on their life stage and incontinence severity.”
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Clinical Trials

Phase 1 Study Measuring Dosing Effects of LSD Completed: Results of Study Will Aid In Planning a Phase 2 Study

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The study was conducted in partnership with University Hospital Basel's Liechti Lab.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

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SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

NuVision ICE Catheter: Positive Results From First-in-human Feasibility Study Reported At 2020 TCT Conference

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"Initial clinical experience of the NuVision ICE Catheter supports safe and effective use with all primary and secondary safety and performance endpoints met and zero adverse events reported," commented Dr. Latib.

PulseSelect Pulsed Field Ablation System by Medtronic: 1st Procedures in Pivotal Trial Reported

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The first procedure in the PULSED AF pivotal trial was performed this week at Southcoast Health by Nitesh Sood, M.D., Fall River, Massachusetts; the second procedure was performed by Arnoldas Giedrimas, M.D., also at Southcoast Health.

DTM Spinal Cord Stimulation 12 Month Study Results Reported by Medtronic

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At 12 months, 84% of patients with chronic back pain treated with DTM Spinal Cord Stimulation reported at least 50% pain relief, compared to 51% of patients treated with conventional SCS (p=0.0005).

Biotechnology

RELIEF THERAPEUTICS HOLDING SA Announces Plans to Test Aviptadil for Treatment of COVID-induced Acute Respiratory Distress Syndrome

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The phase 2 clinical trial of RLF-100 (Aviptadil) is being coordinated with the Senior Leadership of the Government of Israel for the treatment of Acute Respiratory Distress Syndrome in patients with COVID-19 infection. The trial is being coordinated by Prof. Jonathan Javitt, MD, MPH, acting Chairman of the Scientific Advisory Board of Relief in coordination with Dr. Miki Halberthal, MD, CEO of the Rambam Healthcare Campus and Dr. Boaz Lev, head of Israel’s COVID task force and former Director-General of Israel’s Ministry of Health.

CEL-SCI Initiates Development of Immunotherapy to Treat COVID-19 Coronavirus Infection Using its Patented LEAPS Peptide Technology

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CEL-SCI notes the LEAPS peptides will utilize conserved regions of coronavirus proteins to stimulate protective cell-mediated T cell responses and reduce viral load.

OraSure Technologies Reports OMNIgene®·ORAL Device Now Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test

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The company advises this EUA amendment will allow 3B BlackBio Biotech’s North American distributor, Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S. as well as from their upcoming New Jersey-based laboratory.

BioZone Scientific Technology Independently Confirmed to Be Effective Against SARS-CoV-2, the Virus That Causes COVID-19

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December 10, 2020 BioZone Scientific Technology residential, commercial, and healthcare...

Helix Platform Granted the 1st and Only FDA Authorization for a Whole Exome Sequencing Platform

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Helix advises this marks the first time such a broad, sequencing-based device has been authorized by the FDA.
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New Developments

Funding / Development

Cytomos Secures £5M | To Scale Up Production of Cell-analysis Technology

Medical Device News Magazine -
New investment will allow Cytomos to drive sales of its first commercial product, Celledonia™, built on its cell-analysis technology platform AuraCyt, which is already generating significant market traction.

TactoTek Secures $60 Million in Funding Led by Virala Group

Medical Device News Magazine -
With this funding, TactoTek will accelerate the adoption of IMSE globally by expanding customer-facing operations and streamlining IMSE solution design by augmenting our software-based delivery system with AI elements and plug-ins for CAD and simulation packages

Predictive Heart Monitoring Startup, GPx, Secures NEC X Investment

Medical Device News Magazine -
“GPx’s innovative approach to heart monitoring and chronic disease management is a perfect fit for the NEC Group’s vision of leveraging advanced technology to improve quality of life,” said Shintaro Matsumoto, President and CEO of NEC X. “By joining forces with GPx, we aim to enhance their predictive algorithms and capabilities. Together, we can transform the healthcare industry.”

Bright Uro Announces Oversubscribed $32M Series A Funding Round

Medical Device News Magazine -
Derek Herrera, founder and CEO of Bright Uro. "With this funding, we are well resourced for the launch of Glean in 2025, while also continuing to resource our pipeline of innovation. We have never been more confident in the expected impact Glean will have for clinicians and millions of patients suffering from urinary issues."
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FDA

Non-Profit News

Vergent Bioscience Receives FDA Fast Track Designation for Abenacianine for Injection (VGT-309) to Help Surgeons Visualize Tumors in the Lung During Surgery

“Receiving Fast Track designation from the FDA reinforces the potential of abenacianine to address existing deficits in lung cancer surgery by helping surgeons better visualize tumors in the lung during minimally invasive surgical procedures,” said John Santini, Ph.D., president and chief executive officer at Vergent Bioscience. “We look forward to collaborating with the FDA to make abenacianine available to surgeons and their patients as quickly as possible.”

FDA Grants R3 Vascular IDE Approval for ELITE-BTK Pivotal Trial of its MAGNITUDEÒ Drug Eluting Next Generation Bioresorbable Scaffold for Below-the-Knee Peripheral Arterial Disease

Christopher M. Owens, President and Chief Executive Officer of R3 Vascular. “Initiation of this trial will begin in Q1 2025 and will be conducted at up to 60 global clinical sites with 264 subjects, and upon favorable conclusion will allow the company to complete and pursue a PMA market application for MAGNITUDE with the FDA.”
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Non-Profit News

AAOS Updates Clinical Practice Guideline to Prevent Total Hip and Knee Arthroplasty Periprosthetic Joint Infection in Patients Undergoing Dental Procedures

Medical Device News Magazine -
"Dental procedures are believed to possibly allow bacteria to enter the bloodstream and attach themselves to hip or knee implants, potentially causing PJI in a patient," said Yale Fillingham, MD, FAAOS, co-chair of the AAOS guideline development group. "PJI is one of the most devastating complications for patients following TJA, and we must do everything possible that is supported by evidence to prevent these infections. Given the large number of annual TJA procedures and that most of these patients undergo a dental cleaning at least twice a year, this CPG is relevant to nearly every TJA patient."

Researchers Develop New Coronary Risk Score for Women

Medical Device News Magazine -
A new risk score accurately predicts and categorizes the risk of major adverse cardiovascular events, such as heart attack, in women. The findings were published today in Radiology: Cardiothoracic Imaging, a journal of the Radiological Society of North America (RSNA).
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Medical Device News Magazine

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