FDA has reported a total of10 medical device recallsso far this year, of which seven were reported in February. Seven recalls in a single month is a lot, but not unheard of. Last year there were a total of 32 medical device recalls, accordin... Read More >

CareDx said it has filed a patent infringement suit against Natera in the U.S. District Court for Delaware. The Brisbane, CA-based company said it is asserting U.S. Patent Nos. 9,845,497 and 8,703,652, were exclusively licensed to itfrom Sta... Read More >

Guardant Health is expanding its early cancer detection efforts through a new acquisition. The Redwood City, CA-based firm is set to pick up Bellwether Bio, a private company focused on improving oncology patient care through pioneering rese... Read More >

Bacillusbacteria detection devices were previously unclassified, known as preamendment devices, since they were in commercial distribution prior to May 28, 1976, when the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act... Read More >

PredictImmune announced recently that it has entered a commercial agreement with Addenbrookes Hospital part of Cambridge University Hospitals National Health Service Foundation Trust to provide the companys PredictSure IBD prognostic assay... Read More >

A new study by Veracyte and collaborators demonstrates that the companys Envisia genomic test can improve the diagnosis of patients being evaluated for interstitial lung disease. The study, published this week in Lancet Respiratory Medicine... Read More >

Genomic Health reported recently that its fourth quarter revenues rose 22 percent year over year, beating the consensus Wall Street estimate of $101.5 million. For the three months ended Dec. 31, 2018, the companys total revenues were $104.6... Read More >

Recently, the Wall Street Journal reported that Swiss biopharmaceutical company Roche is acquiring US technology company Spark Theraputics, which may be announced on Monday. The acquisition will value Sparks nearly $5 billion, while the Nasd... Read More >

Danaher Corporation announced that it has entered into a definitive agreement with General Electric to acquire GE Life Sciences GE Biopharma business with a cash purchase price of approximately $21.4 billion. Given the expected tax benefits... Read More >

Icon, an international drug-development and commercialization services firm, has acquired MolecularMD for an undisclosed amount, the companies said recently. MolecularMD, based in Portland, Oregon, is a molecular diagnostic laboratory that s... Read More >