Quest Diagnostics (NYSE:DGX) announced today that consumers can now order a COVID-19 antibody test it launched last week directly from the company, without visiting a doctor’s office. The Secaucus, N.J.-based testing giant said consumers can purchase the antibody test service online for $119 through its QuestDirect business. They will be prompted to schedule an appointment for […]
The FDA has granted two more companies’ COVID-19 tests emergency use authorizations. Tests by Quest Diagnostics (NYSE:DGX) and Quidel Corp. (NSDW:QDEL) got the nod for distribution within the U.S. without prior clearance or approval. Quest Diagnostics (Secaucus, N.J.) said it will expand testing with its new COVID-19 diagnostic this week from its high-complexity laboratories in Chantilly, Va., […]
Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results. The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% on sales […]
Pulmonx said yesterday that it named Glen French, the co-founder and CEO of Asthmatx who led it to an acquisition by BSX, to be its new president and chief executive.
In a sudden switch, Conceptus (NSDQ:CPTS) named Keith Grossman president & CEO upon the resignation of Mark Sieczkarek, whose departure was announced on the heels of lowered sales guidance for 2012.
Sieczkarek’s resignation, after 7 years at the helm, was announced simultaneously with Grossman’s appointment. Grossman will join the company’s board of directors, from which Sieczkarek also resigned.
The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.
MASSDEVICE ON CALL — Singapore’s Awak Technologies Pte. has cut a dialysis machine down to the size of a purse with its portable, wearable artificial kidney.
The product is undergoing animal and lab tests in Singapore and the company hopes to submit data for European and U.S. regulatory review in 2013.
Several U.S. companies are simultaneously developing their own wearable hemodialysis machines, but none have yet hit the market, the Wall Street Journal reported.
Medsquire LLC slapped 14 companies, including some of corporate America’s biggest names, with a patent infringement lawsuit covering electronic medical records systems.
Abbott Laboratories (NYSE:ABT) landed FDA approval for a new testosterone-boosting product.
The company’s AndroGel 1.62% is treatment for male low testosterone levels, also know as hypogonadism, which affects nearly 14 million men in the United States, according to the company.