Mfb Fertility Inc. received CE mark approval for its Proov PdG tests, giving European women direct access to information about ovulation without a prescription. The test enables a woman to test her urine for production of sufficient progesterone to confirm ovulation and favorable conditions for conception.

Pattern Computer Inc.'s test for SARS-CoV-2 infection gives new meaning to rapid results. Taking 15 seconds from start to result, the test offers balanced accuracy of better than 96%, according to the company. The test is also not dependent on timing, unlike current antibody tests, and takes less time than point-of-care PCR tests. Its light-based system creates patterns based on a saliva sample, which is then matched against a previously developed model.

Adela snapped up $60 million in a series A financing round to commercialize its blood test for cancer detection and disease monitoring. At the same time, the company announced its name change from Dnamx Inc. The Adela system profiles all methylated DNA fragments in a blood sample, allowing it to determine the tissue of origin early in development of a malignancy and potentially simplifying screening across all cancer types.

Avicenna.AI has enjoyed a head-spinning series of regulatory nods for its artificial intelligence (AI)-based solutions for serious vascular conditions including stroke, pulmonary embolism (PE) and aortic dissection. The Marseille, France-based company gained CE mark for its tool that quantifies the severity of a stroke based on a CT scan of the brain and displays regions that have suffered infarcts in late May, followed by CE mark and FDA 510(k) clearance for its product that permits emergency triage of PE and aortic dissection from CT-scan imaging in early June.

Cleerly Inc. snapped up $43 million in a series B fundraising round to develop artificial intelligence (AI)-enhanced imaging to better understand heart disease and more accurately project patient outcomes. Vensana Capital led the round with participation from the American College of Cardiology, Cigna Ventures, Dititx Partners, Lrvhealth (formerly Long River Ventures), New Leaf Venture Partners and returning investors.

Brain Scientific Inc. plans to acquire Piezo Motion Corp. in an all-stock transaction expected to close in July 2021. The deal depends in part on the successful closing of a $5 million funding round. At closing, Brain Scientific will acquire 100% of Piezo’s outstanding shares along with its assets and liabilities. Piezo Motion’s shareholders will receive the number of shares of Brain Scientific’s common stock equal to 100% of its issued and outstanding shares immediately prior to closing on a fully diluted, as converted basis.

Mindup, an Israeli digital health incubator, added Phenofast Ltd. to its portfolio this week, banking on the startup’s ability to resolve a critical, ongoing problem for hospitals and community physicians treating patients with urinary tract infections (UTIs). Phenofast hopes to bring clarity to antimicrobial susceptibility testing (AST) and relief to patients in record time.

Acutus Medical Inc. scored big with regulators in recent weeks. The company, which focuses on devices to diagnose and treat cardiac arrhythmias, received FDA approval to launch an investigational device exemption clinical trial for its Acqblate Force sensing ablation catheter and system in atrial fibrillation just two weeks after gaining CE mark approval for a broad suite of electrophysiology products.

Hemex Health Inc.’s newborn screening for sickle cell disease substantially reduces the labor involved for parents and providers in testing for the potentially fatal condition. The test had previously been able to test infants 6 weeks and older on the company’s Gazelle platform.

10x Genomics Inc. began distribution of its new Visium Spatial Gene Expression for FFPE (formalin-fixed and paraffin-embedded) assay in the U.S., giving researchers access to whole transcriptome spatial gene expression across entire FFPE tissue samples. The assay allows researchers to overcome the challenges in transcriptome analysis created by FFPE processing.