In June 2022, we have identified the following product launches and approvals that caught our attention from the diagnostics perspective. Check them out:
1. Prepping for FDA approval, Grail is partnering with health systems to validate its pan-cancer test
Grail, a company focused on early cancer detection, introduced its test that screens for more than 50 kinds of cancer last year.
2. Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe
Senseonics has received a CE mark for its six-month Eversense E3 continuous glucose monitoring implant, positioning its commercial partner to start selling the device in the third quarter.
3. Apple Watch monitoring features for AFib, Parkinson's cleared by FDA
Apple received 510(k) clearance for a feature for its smart watch on atrial fibrillation (AFib). It also disclosed a new feature to monitor Parkinson's disease patients, an 510(k) clearted app designed by Rune Labs.
4. AI colorectal cancer diagnostics receives CE-IVD mark
DoMore Diagnostics, a developer of pathology AI algorithms, has achieved CE-IVD mark for the Histotype Px Colorectal, a deep learning algorithm that predict patient outcome based on analysis of digital histology images.
5. Proscia’s Cocentriq Scores IVDR
Concentriq Dx helps shift the standard of care from microscope to image. It combines an intuitive experience for viewing and assessing images with best-of-breed interoperability, improving efficiency and collaboration for even the largest multi-site networks.
6. Paige Gets CE-IVD Mark, UK Regulatory Approval for Breast Cancer Biomarker Software
7. AnchorDx Receives CE Mark for Lung Cancer Early Diagnosis Test
8. PocDoc to roll out digital cardiovascular testing across Scotland
PocDoc, the digital health platform and personal diagnostics provider, has announced an exclusive partnership with Dears Pharmacy to improve access to regular testing for cardiovascular diseases (CVD).
9. Skin Analytics receives UKCA mark for dermatology diagnostic
AI dermatology company Skin Analytics has received regulatory clearance in the UK to drive clinical management.
10. Bacterial and viral infection diagnostic launched in Israel
Following US Food and Drug Administration (FDA) clearance of the MeMed BV test, Maccabi Healthcare Services is launching the test in all its urgent care centres around Israel.
11. Proposed LDT regulations has diagnostics industry, consumer groups at odds
Consumer advocates say the proposed legislation has too many exemptions, while industry groups seek to limit premarket review requirements for legacy tests.
12. Sophia Genetics Gets CE-IVD Mark for DDM Platform's Analytics
13. Thermo Fisher Scientific Receives CE-IVD Mark for NGS Aneuploidy Diagnostic Software Workflows