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Annoviant awarded $3M NIH grant for pediatric pulmonary-valved conduit

Annoviant recently announced it was awarded a $2.99 million National Institutes of Health grant to advance its TxGuard pulmonary-valved conduit for pediatric heart disease.

The grant, an SBIR Phase 2 b grant, will help the Atlanta-based company accelerate the development and commercialization of its technology. It builds upon the company’s previous Phase 2 NIH grant issued in 2021.

“We are delighted to receive this additional grant from the NIH, accompanied by matching funds from our esteemed investors. This marks a significant milestone for Annoviant as we accelerate our pursuit of impactful innovation to save lives,” Co-founder and CEO Ajay Houde said in a news release.

Annoviant’s TxGuard is used in conduit replacements to treat congenital heart disease (CHD). According to the company, the condition affects approximately 40,000 newborns annually in the U.S. and 1.35 million worldwide.

The device is resistant to calcifica…

GE HealthCare adds MIM Software to Elekta collaboration

GE HealthCare (Nasdaq: GEHC) + announced today that it expanded its relationship with Elekta with more collaboration on software for radiation oncology.

Together, the companies aim to accelerate innovation in software to improve workflows, increase throughput and enhance user experience. They expect to enable greater precision in radiation therapy treatment with less time at the hospital for patients.

It builds on a collaboration between GE HealthCare and Elekta first announced just over two years ago. The latest expansion adds in MIM Software, which GE HealthCare acquired just weeks ago. MIM Software provides AI-based software for radiation oncology, molecular radiotherapy, diagnostic imaging and urology.

“Our decision to join GE HealthCare was driven by a ‘shared vision of maximizing impact’ and our motivation for this collaboration with Elekta is no different,” said Andy Nelson, CEO of MIM Software, GE Health…

FDA clears new Zenition 30 mobile C-arm from Philips

The Zenition 30 system in use. [Image courtesy of Philips]Philips (NYSE: PHG) + announced today that the FDA granted 510(k) clearance for its Zenition 30 mobile C-arm.

Zenition 30 reduces the dependency on support personnel by giving surgeons greater flexibility, control and personalization of C-arm movement and user settings. This can help to alleviate staff shortages that limit patient access and increase waiting times. It could also address budgetary constraints that affect today’s hospital systems.

With enhanced workflow efficiency through C-arm control alongside the patient table, surgeons can treat more patients. All the while, they can spend more time focusing on each patient, leading to a better patient and staff experience.

Zenition 30 features Philips’ latest-generation flat detector technology, advanced imaging algorithms and personalized user profiles. It delivers superior image quality, cou…

New features of updated Medtronic GI Genius include room for third-party SaMD developers

Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong discusses new GI Genius features, design improvements and how other device developers can jump aboard.

Medtronic Endoscopy Chief AI Officer Ha Hong [Photo by Hardy Wilson for Medical Design & Outsourcing]

The latest version of the AI-powered Medtronic GI Genius system for colonoscopy is smarter, more helpful, and has room for third-party apps developed by other devicemakers.

Those third-party software-as-a-medical-device (SaMD) apps “could be anything,” Medtronic Endoscopy Chief Artificial Intelligence Officer Ha Hong said in an interview with Medical Design & Outsourcing.

“The beauty of the GI Genius system is that it’s already been deployed by thousands of hospitals worldwide,” he said. “And as long as the hospital has the system already, the third-party application developers will be able to t…

Concept Medical enrolls first patient in drug-coated balloon study

Concept Medical announced today that it commenced the FDA investigational device exemption (IDE) study of its MagicTouch system.

MagicTouch, a sirolimus drug-coated balloon (DCB), treats in-stent restenosis (ISR) in coronary artery disease (CAD). Dr. Said Ashraf enrolled the first patient in the MAGICAL-ISR study at the AtlantiCare Institute in Atlantic City, New Jersey.

The balloon offers a controlled and sustained release of sirolimus. It mirrors the capabilities of a drug-eluting stent but without the necessity of a permanently implanted scaffold. Concept Medical aims to assess the safety and efficacy of its DCB in the trial with a focus on patients avoiding target lesion failure (TLF) at one year post-procedure. The study began under the guidance of Dr. Martin Leon, Dr. Azeem Latib and Dr. Ajay J. Kirtane.

Concept Medical said that its MAGICAL-ISR study underscores its “dedication to clinical excellence and innovation.”

“We a…

CroíValve is set to challenge as tricuspid regurgitation treatment space heats up

The Duo tricuspid valve device. [Image courtesy of CroíValve]With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way.

Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an FDA nod. With Edwards’ device designed to replace the native valve and Abbott’s designed to repair it, CroíValve’s investigational Duo tricuspid coaptation valve system could bring the best of both to the table.

“We’re seen as sort of the best of both worlds,” CEO Lucy O’Keeffe told MassDevice in an interview.

Duo features a coaptation valve that works in tandem with the native tricuspid valve to restore valve function. Delivered using percutaneous techniques, Duo is anchored in a novel way — it …

Smart AED maker Avive raises $56.6M

The Avive Connect AED.

Connected automated external defibrillator (AED) maker Avive Solutions announced that it closed a $56.5 million growth equity financing.

Questa Capital, Laerdal Million Lives Fund (LMLF) and Catalyst Health Ventures led the financing round. New investors, including RC Capital and Eckuity Capital, also participated.

San Francisco-based Avive plans to use the funds to accelerate its commercial developments in the U.S. and to expand its team. The company aims to improve cardiac arrest survival rates by offer portable, ready-to-use AEDs in communities, schools, businesses and homes. It wants to create a new paradigm, making AEDs accessible in the critical early minutes of a cardiac emergency.

The Avive Connect AED delivers robust internet connectivity through cellular, WiFi, GPS and Bluetooth integration. It features the Avive Intelligent Response Platform, powering a “4-Minute City” program. This aims to improve survival r…

Intuitive beats the Street in Q1, increases procedure volume forecast

Intuitive Surgical placed eight of its next-generation da Vinci 5 systems in the first quarter of 2024. [Image courtesy of Intuitive Surgical]Intuitive Surgical (Nasdaq: ISRG) + posted first-quarter results today that exceeded the consensus forecast on Wall Street while increasing its forecast for full-year procedure growth.

The Sunnyvale, California-based surgical robotics leader reported profits of $545 million, or $1.51 per diluted share, for the three months ended March 31, 2024, up 53% from the first quarter of 2023.

Total revenue was $1.89 billion for the quarter, up 11% from the same period a year ago. Intuitive cited procedure volume growth and an increase in its installed base of systems.

Global da Vinci procedures grew approximately 16% from the same quarter a year ago. Intuitive placed 313 da Vinci surgical systems during the quarter, compared to 312 from the prior-year period.

Intuitive’s t…

GE HealthCare launches new AI-enhanced ultrasound for women’s health

The Voluson Signature 20 system. [Image from the GE HealthCare website]GE HealthCare (Nasdaq: GEHC) + announced today that it launched the Voluson Signature 20 and 18 ultrasound systems for women’s health imaging applications.

Chicago-based GE HealthCare designed the systems to integrate AI, advanced tools and an ergonomic design. They speed exam time for clinicians while delivering a clearer picture of various conditions impacting women’s health. The latest systems combine high-performance hardware with flexible, scalable software to help increase confidence in diagnostic and treatment decisions.

The company said in a news release that AI-enabled ultrasound technologies support clear, quick and confident diagnoses. This latest launch helps to address patient demand and reduce staffing burdens by giving clinicians these tools. Dr. Ben Csapo, a maternal fetal medicine specialist in Graz, Austria, said AI enable…

Ferring Pharmaceuticals, SK Pharmteco enter commercial gene therapy manufacturing deal

Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for Ferring’s drug substance intravesical non-replicating gene therapy, Adstiladrin.

The deal will help ensure the long-term future supply of gene therapy. Following the technology transfer, SK pharmteco will be qualified as another source for manufacturing, testing and release of the medicine, subject to FDA approval.

Ferring’s Adstiladrin was FDA-approved in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors.

“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin,” CEO Joerg Ahlgrimm said. “Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-proce…

TriLink BioTechnologies opens new mRNA manufacturing facility

TriLink BioTechnologies today announced it opened its new cGMP mRNA manufacturing facility.

The new 32,000 sq. ft. facility, based in San Diego, is specifically designed for mRNA manufacturing. Using the company’s mRNA manufacturing capabilities, it will support late-phase drug developers from Phase 2 to commercialization. TriLink said the opening is expected to help advance the field of mRNA-based medicine.

TriLink’s new facility has individual Grade C cleanroom suites for mRNA manufacturing, increased mRNA capacity, comprehensive in-house analytical services and laboratory space for on-site quality control testing. The manufacturing site is also outfitted with “state-of-the-art” equipment and is ready to onboard clients with late-phase manufacturing needs.

“This facility is expected to help move the needle for life-saving breakthroughs in mRNA therapeutics,” Kevin Lynch, VP and GM of TriLink’s GMP operations, said in a new…

Bessel launches accelerator program for medtech startups

Bessel and an Alabama tech hub today said they are launching Hatch Powered by Bessel, an accelerator program for medtech startups.

Applications are now open for the 10-week program, which starts in Fairhope, Alabama, this summer.

The accelerator “combines the passion of startup founders, the guidance of seasoned medical device experts, and the burgeoning startup ecosystem and investment in Alabama,” Bessel said in a news release. “… The program aims to equip medtech startups to create sustainable and scalable innovations—breakthroughs that scale—and to give founders the entrepreneurial resource ecosystem they need for long-term success.”

Startups selected for the program will receive a travel stipend, access to events and workshops, and guidance on strategy, fundraising and execution from lifescience industry entrepreneurs who will act as mentors and advisors.

The startups will be offered funding…