Redwood City, Calif.-based Q Bio Inc., which is offering a quantitative assessment of personal health, has come out of stealth mode, scooping up $40 million in a series B funding round led by Andreessen Horowitz. The funds are earmarked to improve its proprietary platform and technology to make its preventive health services faster, better and more affordable for all.

Making routine diagnostic blood tests less invasive, easier, cheaper and more accessible is a worthy goal. But achieving it has eluded many, including former unicorn startup Theranos that boasted it had achieved precisely that but then was later exposed as a fraud. Established med-tech player Becton, Dickinson and Co. (BD) and Babson Diagnostics Inc. have established a long-term strategic partnership to bring laboratory quality, small-volume blood collection into the retail pharmacy setting.

The 2.3% medical device tax is a thing of the past, and now Medicare coverage is one of the issues that is front and center for the Medical Device Manufacturers Association. MDMA President and CEO Mark Leahey told BioWorld also that while member companies are keen on regulatory harmonization, the struggles in standing up the new European regulatory framework is a far more pressing concern.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has issued a draft guidance to help sponsors better understand the evidence requirements for market authorizations for medical devices, including in vitro diagnostics (IVDs) and software as a medical device (SaMD).

The results from a study comparing San Diego-based Bionano Genomics Inc.’s Saphyr to traditional cytogenetic methods for the clinical analysis of leukemia genomes revealed that the system was 100% concordant with the standard of care for the detection of somatic chromosomal abnormalities.

BEIJING – Researchers from The Hong Kong Polytechnic University (PolyU) have developed a diagnostic system that they claim is the world’s most comprehensive as it can identify 30 to 40 pathogens in one single test within an hour.

PERTH, Australia – As of Feb. 12, Australia’s Department of Health confirmed 15 cases of novel coronavirus in Australia (five in Queensland, four in New South Wales, four in Victoria and two in South Australia). Of the confirmed 15 cases, five people have recovered and the others are in stable condition.

Guilford, Conn.-based Hyperfine Research Inc. has received the U.S. FDA’s nod for a bedside magnetic resonance imaging (MRI) system and is eyeing this summer for shipments. The portable system can be wheeled directly to the patient’s bedside and plugs into a standard electrical wall outlet.