Topic:

Diagnostics

Latest Headlines

Latest Headlines

China medical device market to top Japan to claim No. 2 spot globally

China's market for medical devices is expected to pass Japan's this year to become the world's second-largest, topped only by the United States. A consulting firm forecast China's market would pass the $55 billion mark this year.

China FDA approves Agilent's microarray scanner for in vitro diagnostics

Agilent Technologies announced that its SureScan Dx microarray scanner has been approved by the China Food and Drug Administration.

Siemens preps for healthcare spinoff with exec shuffle, but profits slide

Siemens reorganized its board and management in preparation for the long-planned spinoff of its healthcare business. The move comes as profits slip for the conglomerate's healthcare offerings, although revenues for the group continue to grow.

Mayo Clinic study finds molecular breast imaging useful for cancer detection in dense breasts

It's notoriously difficult for mammography to detect tumors in dense breast tissue. Now a recent study by the Mayo Clinic has found that adding molecular breast imaging (MBI) can effectively detect more cancers than mammography alone in dense breasts.

The latest trend in home healthcare: Portable X-rays

Healthcare is migrating to patients' homes for reasons like cost and convenience. X-rays are the latest example, thanks to the rise of digital and portable machines. Reuters reports that patients are increasingly inviting the radiologist into their house rather than receiving X-rays at the hospital, a trend that rankles some experts in the field.

Bill introduced in Congress to simplify marketing of 'research use only' devices and diagnostics

The Medical Testing Availability Act of 2015 would restrict the ability of the FDA to enforce tacit marketing of "research use only" diagnostics for clinical purposes. The bill is sponsored by Rep. Michael Burgess (R-TX), who is also spearheading opposition on Capitol Hill to FDA's plans to regulate laboratory-developed tests.

LabCorp-backed GeneCentric raising $20M Series B to build portfolio of molecular diagnostic tests

No one would argue that startups are particularly good at securing reimbursement and sales for their molecular diagnostic tests. That's where GeneCentric Diagnostics is stepping in to fill the gap by in-licensing molecular diagnostic tests, developing the clinical trial data for them to secure adoption and reimbursement.

What's next for next-gen sequencing? Everything.

SAN FRANCISCO--More than a few presentations at the JP Morgan Healthcare conference this week sought to address the future of next-generation sequencing, particularly with the huge waves of related news.

JP Morgan: 23andMe sharing data on 650,000 patients with Pfizer

23andMe's strategy of selling its database of genetic data to Big Pharma companies continues to bear fruit. The Google-backed company is sharing data about the DNA of 650,000 individuals with Pfizer to help that company in its R&D efforts.

FDA approves first blood screening test to detect HIV, HCV and HBV from Roche

The FDA has approved a triple test from Roche to simultaneously detect HIV, hepatitis C and hepatitis B in donated blood and blood products. It's the first test approved by the agency to simultaneously test for all three of these blood-borne diseases and is expected to reduce the necessary sample volume and the testing turnaround time.