The latest regulatory, legal, compliance, and technology news for labs and pathology practices.

Subscribe today for access to
Articles and Reports

Latest Articles

Hematology Testing Solution Company Earns Key Grant

YOKNEAM ILLIT, ISRAEL — PixCell Medical, innovator of rapid hematology testing solutions at the point-of-care, announced on Feb. 22 that it has been awarded a grant by the International Health-Tech Pilot Program. PixCell will utilize this grant to develop and...

Closeup of blood samples in a rack.

Helping Patients with Cancer Better Manage Ocular Toxicities

CAMBRIDGE, MA — On Feb. 23, Voluntis, an Aptar Pharma company and leader in digital therapeutics, announced a partnership with Tilak Healthcare, a digital therapeutics company specializing in clinically validated medical mobile apps for chronic diseases. Under this...

Closeup of woman's eyes and nose.

Deep Learning Poised to Improve Breast Cancer Imaging

WASHINGTON, DC — Researchers have developed a new image reconstruction approach that could contribute to better breast cancer detection. The deep learning algorithm overcomes a major hurdle in multi-modality imaging by allowing images to be recovered in real time....

Breast cancer - ductal carcinoma in situ (DCIS): Tumor cells are confined to the mammary ducts. No invasion is seen (photographed and uploaded by US board certified surgical pathologist).

Feds Target Fraudulent Billing of Genetic Cancer Tests

False ordering and billing of cancer genetic (CGx) tests has become a favorite target for federal fraud enforcers, with the U.S. Department of Justice (DOJ) reporting two notable convictions in the closing months of 2021. On Nov. 17, a 57-year-old former lab sales...

DNA analysis concept. Background of genome sequence.

Labcorp Completes Acquisition of Personal Genome Diagnostics

BURLINGTON, NC — Labcorp, a leading global life sciences company, announced Feb. 21 that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products....

Digital screen with DNA strands and data background. Double helix structure. Nucleic acid sequence. Genetic research. 3d illustration.

Startup Awarded NIH Grant to Develop Endometriosis Test

OAKLAND, CA — NextGen Jane, a genomics startup generating big data for novel applications in molecular diagnostics and drug development for female reproductive disorders, announced that it has received the green light for the second phase of a Small Business...

Endometriosis, virtual model of the uterus, close-up. Woman suffering from menstrual pain, while sitting on bed.

Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test

On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...

Pcr well plate on 96 well microplate with biological samples.