Quest Diagnostics (NYSE:DGX) has received an FDA emergency use authorization (EUA) for an at-home diagnostic test for COVID-19. The Secaucus, N.J.-based testing giant said the test kit is for individuals to self-collect a nasal specimen at home or in a healthcare setting when determined to be appropriate by a healthcare provider. It allows an individual to […]
Quest Diagnostics Inc.
Quest Diagnostics launches patient-ordered COVID-19 antibody test
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 […]
Quest Diagnostics, Quidel Corp. get emergency nod for COVID-19 tests
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., […]
Quest Diagnostics posts mixed Q1
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 taps ex-Asthmatx CEO French for the corner office | Personnel Moves
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.
Hill-Rom rises on Q3 prelims, needs new CFO
Rusckowski out, DiSanzo in at Philips Healthcare
Steve Rusckowski is leaving the corner office at Philips Healthcare (NYSE:PHG) to succeed Quest Diagnostics (NYSE:DGX) CEO Surya Mohapatra.
Conceptus names new CEO, lowers 2012 guidance | Personnel Moves
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.
Med-tech industry to FDA: IOM’s 510(k) report falls way short
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.
Kidney dialysis in a purse | MassDevice.com On Call
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.
[sead]
Medsquire sues Quest, HP, 12 others in HIT patent spat
Medsquire LLC slapped 14 companies, including some of corporate America’s biggest names, with a patent infringement lawsuit covering electronic medical records systems.