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Medical Device Industry News: Latest Developments, Breakthroughs, and Future Outlook
Medtronic Announces MiniMed as Name for Planned New Diabetes Company
The name honors the company’s roots, reflecting its original name prior to its acquisition by Medtronic in 2001, and a deep 40-year history of being at the forefront of transforming diabetes care around the world.
Project Uses AI to Develop an Innovative System for Diagnosing and Rehabilitating Joint Conditions
This tool offers comprehensive monitoring of musculoskeletal disease progression in each patient, enabling more effective medical and rehabilitation interventions while reducing economic impact. The KINESSENSOR project, funded by IVACE+i and the ERDF, facilitates personalized treatments, thereby improving their effectiveness.
NanoHive Medical Sublicenses DirectSync’s Piezoelectric Patents to Explore Development of Hive™ Soft Titanium® 3D Printed Spine Interbody Fusion “Smart Implant”
NanoHive’s Soft Titanium® technology is the ideal interbody fusion implant to deliver a sensor with data collection and bone stimulation capability. The company is excited about the prospect of leading the way with the development of a technological leap in the interbody fusion device category.

Solventum Launches Preassembled, See-through VH2O2 Test Pack for Low-temp Medical Instrument Sterilization
The ready-to-use test integrates two previously FDA-cleared indicators – a biological indicator for confirming microbial neutralization and a chemical indicator for verifying proper sterilizer function – into a single-use test pack with a transparent container.
Clinical Trials
Enterprise Therapeutics Publishes on Medicinal Chemistry of ETD001 | A Novel Inhaled ENaC Blocker for Treatment of Cystic Fibrosis
The paper describes the medicinal chemistry optimisation of a new series of ENaC blockers, resulting in the invention of ETD001, Enterprise’s lead asset, a potential new inhaled treatment for cystic fibrosis notes Enterprise Therapeutics.
Elixir Medical Reports | LithiX HC-IVL System Data Demonstrate Sustained Safety and Efficacy at Six Months
“We developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we’re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “Our team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.”
SPYRAL HTN-ON MED Study Update | Shows significant, consistent, long-term blood pressure lowering effect at two years
“These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension,” stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. “Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs.”
Biotechnology News
Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
“The CHMP’s recommendation for approval of VYJUVEK is an exciting step towards our goal of delivering the first ever corrective therapy to DEB patients across Europe,” said Suma Krishnan, President of Research and Development at Krystal Biotech. “The CHMP’s support for a broad label, including treatment of patients from birth and the option of patient or caregiver administration at home, are also fantastic outcomes for the DEB patients we aim to serve, broadening access and reducing barriers to starting on and staying on therapy.”
Fosun Pharma Received NMPA Approval for Wan Ti Le | (Tenapanor Hydrochloride Tablets)
As the world’s first and currently only approved phosphate absorption inhibitor, Tenapanor Hydrochloride Tablets has been officially approved in China, ushering in a new era of multi-mechanism synergistic phosphate control and offering new hope for patients with hyperphosphatemia on hemodialysis in China.
EPO Grants Key CRISPR Patent to ERS Genomics CVC Portfolio
John E Milad, CEO of ERS Genomics, said: “The EPO’s decision to grant EP 4 289 948 with broad claims reinforces CVC’s leadership position in CRISPR IP in Europe and validates our strategic decision to self-revoke two legacy CRISPR/Cas9 patents. This decision provides our 150+ licensees with greater confidence in their rights, while maintaining CVC’s established patent leadership in Europe.”
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Digital Pathology Reaches an Inflection Point as AI Targets Workflow Gaps | By Yair Rivenson, PhD Founder and CEO, Pictor Labs
Laboratories face mounting pressure to modernize imaging, preserve tissue, and reduce sequencing failures as adoption continues to move at a glacial pace

FIZE Medical Launches 5,000-Patient Retrospective Study to Further Establish the benefits of using FIZE kUO in managing ICU patients’ Hemodynamic status
By continuously capturing renal function patterns, the study aims to demonstrate how FIZE kUO® can provide data for early signs of instability that are often missed by intermittent measurements

Skin May Become the First Organ to Fulfill the Promise of Regenerative Medicine | By Dr. Ned Swanson – President & Chief Medical Officer of PolarityBio
The field of regenerative medicine may be on the cusp of an evolution, and due to the unique attributes of skin and wounds, the largest organ in the body may be emerging as a leader
FDA Medical Device Updates
Comprehensive Insights into Medical Device & Biotechnology Company Mergers, Acquisitions & Funding
Hanger Ventures Announces Inaugural Investment
“We are thrilled to make our inaugural investment in Bionic Power,” shared James Campbell, Ph.D., Hanger Ventures President and Hanger, Inc. Chief Clinical Officer. “We look forward to contributing clinical research, along with technical and commercial expertise, to bring innovative solutions to the market that have the potential to meet an unmet clinical need and improve the quality of life for individuals with mobility challenges.”

Novocuff Raises $26 Million in Oversubscribed Series A Funding to Advance Technology Aimed at Reducing Preterm Births
“We are thrilled to have the support of a strong and mission-aligned group of investors as we enter this exciting next phase of clinical development,” said Amelia “Amy” Degenkolb, CEO & Co-founder of Novocuff. “This funding catalyzes our ability to deliver a solution to a healthcare need for women, and their families and healthcare providers.”
Digestiva Closes $18.4 million Series A Financing
Digestiva reports this significant milestone was led by Magdalena, a global leader in sugar cane processing, with participation from UC Investments, and existing investors The March Fund and Astanor. The company’s groundbreaking enzyme technology platform was initially discovered by co-founder Dr. Wilson Mak, in the lab of renowned UC Davis faculty member Dr. Justin Siegel, a global leader in enzyme discovery, development, and design.
Neuspera Medical Raises $23 Million in Series D Financing
Neuspera Medical notes this round will fund the company though expected U.S. Food and Drug Association (FDA) premarket approval (PMA) of the Neuspera System, the discreet, minimally invasive, ultra-miniaturized implant designed to provide patients personal control and relief from urinary urge incontinence (UUI), a symptom of overactive bladder (OAB).
Market Reports
Advancements in Imaging
SyMRI 3D by SyntheticMR Set for Early 2024 Commercial Launch Post Obtaining CE-Marking
“We are delighted to see our 3D solution CE-marked and available on the European market,” says Ulrik Harrysson, CEO at SyntheticMR AB. “SyMRI 3D represents the next generation of quantitative MRI, offering unprecedented resolution and accuracy in brain imaging, revolutionizing the landscape of medical diagnostics.”
Perimeter Medical Imaging AI Announces Further Commercial Expansion in North Texas with Follow-On Placement of Perimeter S-Series OCT within National Healthcare Provider System
Adrian Mendes, Perimeter’s Chief Executive Officer, stated, “We believe this additional commercial placement within a major national healthcare system – representing the fifth unit placed with this existing customer network – demonstrates that surgeon end users, as well as other stakeholders within the broader healthcare system, see the value of our technology and are recommending it to their peers. Our aim is to make Perimeter’s innovative technology the standard of care in cancer surgery.”
Vidhance for Remote Assistance Software Suite Transforms Surgeon Training and Expands Global Surgical Access
Vidhance for Remote Assistance not only improves today’s limitations of head-mounted cameras but also contributes to the transformation of how surgical training is conducted.
Hospitals In the News
Medical Device and Biotechnology Executives: Innovative Professionals on the Move and Making Waves in the Industry
Non-Profit News
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