ThinkMedTek

Monday September 25

1. Researchers from the University of Geneva, University Hospitals of Geneva, Imperial College London, and Amsterdam UMC have discovered that a high density of the TSPO protein, commonly used in medical imaging to locate microglia in the brain, corresponds to a high density of these cells, but it doesn’t indicate their overactivation during neuroinflammatory processes. This finding paves the way for better observation of neuroinflammatory mechanisms and a re-evaluation of previous studies on the subject, offering insights into neurological and psychiatric diseases’ immune mechanisms.
2. Researchers from Harvard University have developed a new 3D printing technique using fiber-infused ink to create functional heart ventricles that mimic the beating of a human heart. The fiber-infused gel (FIG) ink allows heart muscle cells to align and beat in coordination, opening up possibilities for creating complex 3D structures for testing drug safety and regenerative therapeutics in the future.
3. A modified version of Virtual Incision’s MIRA surgical robot is set to undergo testing on the International Space Station in 2024 to perform simulated surgical tasks as part of a collaboration between NASA and the University of Nebraska-Lincoln. The goal is to prepare for telesurgery in space, with the robot initially designed for minimally invasive procedures on Earth, with future applications including hernia repair, gallbladder removal, and various other surgeries.

Tuesday September 26th

4. The FDA has approved ZimVie’s investigational device exemption (IDE) application for a study that will follow patients undergoing simultaneous cervical disc arthroplasty and anterior cervical discectomy and fusion at adjacent levels between C3 and C7. This study aims to gather clinical data for the use of cervical disc replacement in hybrid constructs, potentially offering a more efficient and cost-effective treatment option for certain patients with cervical disc issues.
5. Enovis, a US-based orthopedics company, is set to acquire LimaCorporate S.p.A (Lima), a surgical implant maker, in a deal valued at €800 million ($847 million). This acquisition will expand Enovis’s product portfolio, global reach, and revenue, offering patient-tailored orthopedic solutions and technologies, including 3D printed Trabecular Titanium.
6. iRhythm Technologies has launched its next-generation Zio monitor in the U.S., providing an enhanced cardiac monitoring experience for patients. The Zio monitor is smaller, lighter, and thinner than previous versions, offering improved wear times, comfort, and patient experience, along with advanced AI algorithms for more accurate ECG data analysis, benefiting both patients and healthcare providers.

Wednesday September 27th

7. Qosina, a global supplier of OEM single-use components to the medical and pharmaceutical industries, has introduced the RondelO™ stopcock manifold, the world’s first medical stopcock with a patented design enabling a serial sequence of incompatible drugs and flushing fluid between them. This innovative product simplifies drug infusion protocols, offering features like automatic flushing and easy sampling in the bioprocess industry, revolutionizing medical and bioprocessing procedures.
8. Los Angeles-based QT Medical has secured $12 million in a Series B financing round to bolster its cardiac care technology. The funding will be used to accelerate market penetration, global expansion, product development, and long-term planning for its flagship device, the Personal Cardiac Assistant (PCA 500), a hospital-grade, wireless 12-lead ECG device designed for convenience and portability, weighing only 2.3 ounces and fitting in a shirt pocket, enabling personalized cardiac care at home and in various healthcare settings.
9. The FDA has released final guidance to assist medical device manufacturers in meeting cybersecurity requirements, as mandated by Congress. The guidance, which follows a draft released last year, outlines risk-based approaches, interoperability considerations, and methods for scoring cybersecurity risks pre- and post-mitigation, aiming to ensure manufacturers comply with regulations before the agency’s “refuse to accept” decisions come into effect after October 1.

Thursday September 28th

10. Evozyne, a deep learning biotech company, has secured $81 million in a Series B investment round led by OrbiMed and Fidelity Management & Research Company, with participation from previous investors Paragon Biosciences, Valor Equity Partner, and NVIDIA. Evozyne utilizes generative artificial intelligence to simulate millions of years of protein evolution, allowing the identification of diverse protein possibilities, aiming to transform drug discovery by automating the process of identifying new candidates and improving success rates in the biopharmaceutical industry.
11. Inspira Technologies, based in Ra’anana, Israel, plans to introduce its new line of medical devices, the Inspira ART series, at the Extracorporeal Life Support Organization (ELSO) Conference in Seattle. The ART100 cardio-pulmonary bypass (CPB) device, intended for patients undergoing CPB procedures, and the ART500 device, designed to provide acute respiratory support for individuals facing severe breathing problems, are the highlights of the line, with the company expecting ART100 to receive FDA clearance in the first half of 2024.
12. Baltimore-based Galen, a new entrant in the robot-assisted surgery market, has secured additional funding through a bridge round to further develop its robotic surgical platform. Galen’s robot is designed to enhance stability and ergonomics in minimally invasive procedures by working with standard surgical instruments, positioning itself among competitors in the growing robot-assisted surgery sector, including established players like Intuitive Surgical and challengers like Medtronic and Johnson & Johnson.

Friday September 29th

10. Medtech growth company Enovis has announced a definitive agreement to acquire Italian surgical orthopedic implant manufacturer LimaCorporate S.p.A. for approximately €800 million ($850 million). The deal is expected to create a $1 billion revenue reconstruction business, expand Enovis’ global presence, and generate cost synergies through supply chain optimization and cost consolidation, enhancing the company’s position in the orthopedic solutions market.
11. Researchers at Oxford University have developed a miniature biocompatible battery inspired by electric eels, using ion gradients to generate electricity for tiny implantable devices like drug delivery systems. The system involves hydrogel droplets with varying ion concentrations, and by connecting electrodes to this chain of droplets, they can harness the energy generated by ion gradients, paving the way for various applications in bio-integrated devices, implants, and microrobots.
12. The FDA has proposed a rule that would give it explicit authority to regulate lab-developed tests (LDTs) as medical devices, acknowledging that the risks associated with LDTs have significantly increased since the policy of enforcement discretion was established in 1976. The proposed rule aims to address issues such as inadequate validation studies and the marketing of tests lacking adequate evidence, but it has faced pushback from industry stakeholders and could result in legal challenges and potential strain on FDA resources if implemented.

Sources

1. https://www.sciencedaily.com/releases/2023/09/230925124834.htm 
2. https://www.medicaldesignandoutsourcing.com/3d-printed-ventricle-mimic-heart-beating/ 
3. https://www.medtechdive.com/news/virtual-incision-robot-series-C-funding-round/694599/
4. https://www.mddionline.com/orthopedic/fda-approves-zimvies-mobi-c-hybrid-study 
5. https://www.medicaldevice-network.com/news/enovis-to-acquire-limacorporate-in-847m-deal/?cf-view 
6. https://www.massdevice.com/irhythm-launches-next-gen-zio-monitor/ 
7. https://www.medicaldesignandoutsourcing.com/qosina-introduces-rondelo-stopcock-manifolds/
8. https://www.massdevice.com/qt-medical-raises-12m-ecg-device/
9. https://www.medtechdive.com/news/fda-finalizes-guidance-cybersecurity-medical-devices/694857/
10. https://www.medicaldevice-network.com/news/generative-ai-focused-biotech-startup-evozyne-raises-81m/?cf-view
11. https://www.massdevice.com/inspira-unveil-cardiopulmonary-bypass-devices/
12. https://www.medtechdive.com/news/galen-surgical-robot-de-novo-fda-clearance/694951/
13. https://www.mddionline.com/orthopedic/enovis-acquire-limacorporate-800m
14. https://www.medgadget.com/2023/09/droplet-battery-harnesses-ionic-gradients-for-bioelectronic-implants.html
15. https://www.medtechdive.com/news/fda-proposed-rule-lab-developed-tests-regulation/695217/