In July 2022 we have identified the following product launches and approvals that caught our attention from the diagnostics perspective. Check them out:
Qiagen announced a series of enhancements for its QIAcuity series of digital PCR (dPCR) instruments designed to drive greater use among customers, particularly those involved in the biopharma industry.
2. Becton Dickinson Gets CE-IVD Mark for BD Max Combined COVID, Flu, RSV Panel
Becton Dickinson has obtained the CE-IVD mark on a combined panel assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay runs on the firm's BD Max instrument and is now available in countries that recognize the CE mark, the firm said on Thursday
3. Roche Nabs CE Mark for Digital Pathology Slide Scanner
Roche announced that it has received CE marking for its Ventana DP 600 slide scanner for digital pathology.
4. DiaSorin Gets FDA Clearance for Test to Differentiate Bacterial, Viral Infections
DiaSorin said it received 501(k) clearance from the US Food and Drug Administration to market its Liaison MeMed BV, a high-throughput immune-response assay that can differentiate between bacterial and viral infections.
5. Bloom Diagnostics launches test to measure C-Reactive Protein
Swiss medtech company Bloom Diagnostics has launched the Bloom Inflammation Test, designed to test for the quantitative measurement and presence of the C-Reactive Protein (CRP) using the Bloom system.
6. ResApp gets 510(k) clearance for mobile sleep apnoea test SleepCheck
ASX-listed ResApp Health has received the US Food and Drug Administration's 510(k) clearance for SleepCheckRx, its mobile sleep apnoea screening app. Introduced two years ago, SleepCheck is an at-home test for adults who are at risk of moderate to severe obstructive sleep apnoea.
7. iRhythm snags FDA approval for AFib characterization algorithm used in Verily’s wearable
Food and Drug Administration granted another 510(k) clearance to iRhythm Technologies for its AI-powered software system designed for use with Verily’s irregular pulse tracking watch.
8. LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance
A smartwatch-like blood-monitoring device made by LiveMetric that’s cuff-free was granted 510(k) clearance by the Food and Drug Administration
Bio-Techne said on Wednesday that it has recently received CE marking and launched in Europe its assay for human papillomavirus for use in patients with head and neck cancer
10. New CGM Device for Type 2 Diabetes
MySugarWatch has pushed the pedal on an awareness campaign for its continuous non-invasive glucose monitor called sugarBEAT. MySugarWatch is the UK licensee of Nemaura Medical, a company specializing in developing wearable diagnostic devices. The company aims to cater to the awareness needs of the people with pre-diabetes and diabetes