ThinkMedTek

Each day I pick 3 news pieces in MedTech news I find to be the most interesting. Here are the latest updates I found over the last week:

Monday July 24th

1. Focused Ultrasound Foundation Releases State of the Field Report. For all my ultrasound friends, the Foundation released this report last Monday. This is a great report on what is happening in the world of ultrasound for medical devices. It is over 300 pages and is rich with information.

2. FDA’s CDRH Updated Sterilization Standards. The FDA’s Center for Devices and Radiological Health has updated its Recognized Consensus Standards database to include ISO 22441:2022. This supports the use of low-temperature vaporized hydrogen peroxide as an alternate sterilization method.

3. RA Medical has Increased Clinical Adoption for VIVO. Ra Medica’s VIVO system, a noninvasive 3D mapping system is increasing its demand. More and more hospitals are using their device. RA expects to get approvals for VIVO in the coming months in the US.

Tuesday July 25th

4. Specialized cells in the human eye discovered. Researchers have discovered that T cells act as sentinels for the human eye. These cells protect the eye from inflammation and pathogens. Previously this was thought to be a type of immune cell.

5. NeuroOne prices public offering. On July 25th NeuroOne came out with a public offering of 5.25 million shares of common stock at $1 per share. The funds will be used to complete their design of a novel drug delivery electrode among other activities.

6. Biosense Webster introduces OPTRELL Mapping Catheter.  This device utilizes small electrodes to produce high-definition maps of patients with problems with their heartbeat rhythms. This device helps physicians diagnose and treat patients.

Wednesday July 26th 

7. Teleflex acquires urology company. Teleflex reached an agreement with Palette Life Sciences to acquire the company for $600 million. Palette developed a device that protects healthy tissue from radiation during prostate cancer treatment.

8. FDA clears test from Numares Health. This test measures how much lipoprotein is in a patient’s cardiovascular system. This technology uses a mix of machine learning and nuclear magnetic resonance to measure the protein amounts

9. Positive Results from Access Vascular’s catheter. Access Vascular announced this week that they are getting positive results from their new catheter development, HydroPICC. This catheter is constructed of hydrophilic biomaterial with Mimix technology to help reduce complications such as infections.

Thursday July 27th

10. SEC has started to require disclosure of significant cyberattacks. The SEC approved that medical device manufactures are to publicly disclose significant cyberattacks. The details need to be released within four days of determining the impact of the attack.

11. Dexcom has more than doubled their profits. The San Diego company has see significant profits in their second quarter. Dexcom specializes in making continuous glucose monitors. 

12. Soin Neuroscience tests their spinal cord stimulation device. The start up created the device to treat chronic pain in patients. The device uses electrical leads inserted into the spice to deliver the stimulation and relieving the pain perception.

Friday July 28th

13. Telleborg launches family of products, materials, services for fluid path single-use equipment. The company calls this family BioPharmaPro. The family utilizes advanced manufacturing technologies and meets cleanliness and biocompatibility standards.

14. Icotec receives 510(k) clearance for spinal medical products. The products are called VADER Pedicle System NAvigate Instruments and consist of open and minimally invasive surgery instruments.

15. U.S. military tests Bexson Biomedical products. The military intends to field-test their wearable ketamine delivery device. The device utilizes their Sevalent technology which is a platform that works with small molecules across various drug classes.

Want to read more about these new developments? Check out the articles here: 

1. https://cdn.fusfoundation.org/2023/07/21125203/FUSF-State-of-the-Field-Report-2023_July-24.pdf 
2. https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-new-standards-recognition-support-innovation-medical-device-sterilization 
3. https://www.massdevice.com/ra-medical-demand-rising-vivo-system/ 
4. https://www.sciencedaily.com/releases/2023/07/230724182719.htm 
5. https://www.massdevice.com/neuroone-prices-5m-public-offering/ 
6. https://www.medicaldevice-network.com/news/biosense-webster-optrell-mapping-catheter/ 
7. https://www.medtechdive.com/news/teleflex-acquire-palette-urology/689024/ 
8. https://www.medicaldevice-network.com/news/fda-greenlights-numares-healths-lipoprotein-test-for-heart-disease/ 
9. https://www.massdevice.com/access-vasculars-hydropicc-shows-positive-results-in-reducing-clot-formation-and-failures/ 
10. https://www.medicaldesignandoutsourcing.com/device-manufacturers-cyberattacks-new-rules-sec-disclosure/ 
11. https://www.massdevice.com/dexcom-doubles-profits-growth-q2-2023/ 
12. https://www.medicaldevice-network.com/news/soin-tunedtx-low-frequency-stimulation-humans/ 
13. https://www.mddionline.com/manufacturing-processes/trelleborg-launches-biopharmapro-range 
14. https://www.medicaldevice-network.com/news/icotec-vader-pedicle-navigated-instruments/ 
15. https://www.massdevice.com/us-military-bexson-biomedical-ketamine-delivery-device/