ThinkMedTek

Monday October 9th

1. GlucoModicum, in collaboration with Phillips-Medisize, has developed Talisman, a needle-free continuous glucose monitoring (CGM) device utilizing magnetohydrodynamic (MHD) technology. Talisman adheres to a patient’s arm and integrates MHD technology, biosensors, and advanced algorithms, connecting to a smartphone app for data collection and reporting, offering a convenient, rapid, and gentle CGM alternative, although it is not yet FDA approved or CE marked.
2. Cadence, a provider of design, development, and contract manufacturing services to the medical device industry, has acquired the Florida location of ARC Group Worldwide. The acquisition expands Cadence’s vertical manufacturing platform and provides cost-effective methods for volume production, particularly for metal injection molding (MIM) and cleanroom plastic injection molding, aligning with the demand for consolidated metal suppliers in the medical industry.
3. Medtronic’s acquisition of EOFlow, a company specializing in wearable insulin patches, is facing potential challenges after a US court issued a preliminary injunction restraining EOFlow from manufacturing, marketing, or selling products based on Insulet’s trade secrets. The injunction could impact Medtronic’s deal with EOFlow, putting its value and future commercialization at risk, according to RBC Capital Markets analyst Shagun Singh.

Tuesday October 10th

4. Researchers at Johns Hopkins University have developed a new imaging technique that delivers clear pictures of internal anatomy regardless of skin tone. The method, which combines ultrasound and light waves, produces sharper images, particularly in darker-skinned individuals, overcoming biases present in traditional medical imaging technologies. The team aims to apply the technique to breast cancer imaging to enhance both surgical navigation and medical diagnostics.
5. The Sleepiz One+ device, which uses radar technology for contactless monitoring of breathing patterns, respiration rate, and heart rate during sleep, has received FDA Class II 510(k) clearance. The device, developed by Sleepiz, a Minnesota-based company, transforms macro and micro-motion signals into statistics for healthcare professionals, enabling sleep apnea screening at home and monitoring vital signs.
6. Xēnix Medical has received FDA 510(k) clearance for the nanotechnology designation of its neoWave line of interbody fusion implants. The neoWave implant systems feature a patented 3D-printed lattice design that reduces device stiffness without a traditional implant framework or solid walls and incorporates the company’s Nanoactiv surface technology designed to improve fixation of the implant to adjacent bone.

Wednesday October 11th

7. Researchers at the University of Washington have developed CandyCollect, a specially designed lollipop that collects saliva as someone sucks it. The lollipop contains grooves that collect saliva, allowing for non-invasive and more enjoyable sample collection for diagnostic purposes, particularly for children and nervous patients.
8. Penumbra is utilizing virtual reality (VR) to revolutionize patient care by developing therapeutic devices that allow clinicians to monitor and enhance therapy outcomes. The company’s REAL system offers tools to monitor patient progress, improve engagement, and enhance satisfaction during rehabilitation, as well as address cognition and mental wellbeing, transforming the therapy experience.
9. Swedish medtech company Getinge has acquired Healthmark Industries, a US-based provider of instrument care and infection control consumables, for $320 million in cash. The acquisition aims to strengthen Getinge’s position in the US sterile reprocessing market and facilitate Healthmark’s global expansion, as the demand for infection prevention solutions continues to rise globally.

Thursday October 12th

10. Spinal cord stimulation companies, including Medtronic, Abbott, and Nevro, have been competing to secure approvals for treating painful diabetic neuropathy (PDN) with their devices. PDN is a complication of diabetes, and with the growing number of Americans affected by diabetes, the spinal cord stimulation market for PDN is estimated to be worth between $3.5 billion to $5 billion, making it a significant growth opportunity for these companies.
11. GE Healthcare has signed a $44 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop AI-augmented ultrasound technology applications. The point-of-care ultrasound will use AI to expedite trauma triage and treatment, with indications including blunt and penetrating trauma, head trauma, lung injuries, and infectious diseases.
12. Researchers at Monash University have developed a novel simulation paradigm to optimize the outcome of surgery for patients receiving a cortical visual prosthesis, commonly known as a “bionic eye.” The simulation incorporates MRI-derived phosphene maps to identify practical implant locations in the brain’s visual cortex, enabling a more realistic and tailored approach to cortical prosthetic vision, which directly stimulates the brain to restore sight.

Friday October 13th

13. The FDA has released its list of guidance documents for the coming year, covering various topics related to medical devices. Key areas of focus include lifecycle management and premarket submissions for AI and machine learning devices, emergency use authorizations, biocompatibility, sex- and gender-specific data in clinical trials, conformity assessment accreditation scheme, medical device shortages, and 3D printing medical devices at the point of care, among others.
14. Johnson & Johnson’s orthopedic device business, DePuy Synthes, has received FDA 510(k) clearance for its TriLeap lower extremity anatomic plating system. TriLeap is designed to address the specific needs of orthopedic surgeons and foot and ankle specialists, offering a range of plate options and instruments for procedures such as bunionectomies and osteotomies. The company plans to launch TriLeap in the U.S. next year.
15. Philips has launched its Visual Patient Avatar monitoring solution, designed to convey critical patient information to anesthesiologists and anesthetists in a simple visual form. The avatar presents complex data through colors, movement, and shapes, allowing clinicians to quickly understand vital sign information, improving situational awareness, and enabling more efficient and confident care. The design, created in collaboration with clinicians, was inspired by the simple and straightforward illustrations found in an airplane’s dashboard. Studies showed that Visual Patient Avatar significantly improved clinicians’ ability to recall vital signs and reduced perceived workload.

Sources

1. https://www.med-technews.com/news/latest-medtech-news/phillips-medisize-and-glucomodicum-partner-on-glucose-monito/ 
2. https://www.medicaldesignbriefs.com/component/content/article/mdb/stories/news/49300
3. https://www.medtechdive.com/news/insulet-preliminary-injunction-eoflow-patent-lawsuit/695978/
4. https://www.sciencedaily.com/releases/2023/10/231010133534.htm
5. https://www.medicaldevice-network.com/news/sleepiz-wins-fda-clearance-for-device-that-measures-vitals-during-sleep/
6. https://www.mddionline.com/surgical/xenix-medical-nabs-510k-clearance-neowave-implants
7. https://www.medgadget.com/2023/10/lollipop-puts-the-fun-in-saliva-collection.html
8. https://www.medicaldesignandoutsourcing.com/patient-centered-vr-design-fuels-penumbras-immersive-healthcare-future/
9. https://www.massdevice.com/getinge-makes-infection-prevention-play-with-healthmark-buy/
10. https://www.medtechdive.com/news/boston-scientific-diabetic-neuropathy-approval/696382/
11. https://www.mddionline.com/artificial-intelligence/ge-healthcare-signs-44m-deal-barda
12. https://www.sciencedaily.com/releases/2023/10/231012013448.htm
13. https://www.medtechdive.com/news/fda-guidance-ai-cybersecurity-pulse-oximeters-2024-schedule/696234/
14. https://www.massdevice.com/fda-clears-depuy-synthes-trileap-plating-system/
15. https://www.massdevice.com/philips-launches-visual-patient-avatar-monitoring-solution/