Hologic (NSDQ:HOLX) announced that it received FDA approval for a diagnostic claim for its HIV-1 viral load monitoring assay. Marlborough, Mass.-based Hologic’s Aptima HIV-1 Quant Dx assay is now the first dual-claim assay for both diagnosis and viral load monitoring in the U.S., according to a news release. Initially approved in 2016 for viral load monitoring, […]
As we celebrate more women becoming medtech leaders and paving the way for innovation, it’s important to remember the many accomplishments women have already made when it comes to the advancement of health and medicine. X-rays on the battlefield, the American Red Cross, leprosy treatment and more — these advances happened because of women. As […]
Operations came to a grinding halt at New Jersey-based medical device company Energex Systems after founder and former CEO Thomas Fagan was accused of several financial misconduct charges including theft of investor funds, money laundering, corporate misconduct and personal tax evasion.
HIV vaccines are in their infancy, and effective microbicides to prevent sexual transmission of HIV still don’t exist. Women, making up nearly half of the world’s 33 million HIV cases, are especially in need of protection. Here’s a new possible way for women to protect themselves before sex: an applicator filled with specially formulated fatty particles called liposomes.
MASSDEVICE ON CALL — If you can’t bring the village to the lab, you must bring the lab to the village.
Such was the inspiration for the tiny mChip mobile blood testing lab that fits on a credit card and detects HIV and other diseases in minutes.
MASSDEVICE ON CALL — New allegations against Medtronic Inc.’s (NYSE:MDT) Infuse bone growth product may bring down its sales, which were last reported at $800 million per year.
Amid an ongoing investigation into whether Medtronic and its paid consultants concealed information linking the Infuse system to male infertility, a critical review published in the Spine Journal alleged that researchers on the company’s payroll also hid the product’s tendency to cause excess bone growth in the spinal canal.
Medtronic Inc. (NYSE:MDT) announced Tuesday that its CoreValve System, designed to enable the replacement of a diseased aortic valve without open heart surgery, showed health improvements over a two-year period on patients implanted with the device. The CoreValve device won CE Mark approval in 2007.
The two-year study involved 126 patients at nine centers in Europe and Canada. The Fridley, Minn. company released the data at EuroPCR in Paris, France, an annual event that highlights the latest techniques, updates and breakthroughs in cardiovascular science.
PointCare Technologies Inc. raised $1.8 million of a possible $3.5 million round, according to documents filed with the federal Securities & Exchange Commission.
The Marlborough, Mass.-based diagnostics maker develops a mobile point-of-care blood analyzer for people with HIV/AIDS in low-resource settings such as Nigeria, Senegal and Zambia.
The Centers for Medicare and Medicaid Services shifted gears on its reimbursement policy for both standard and rapid HIV tests, in an attempt to catch more undiagnosed cases in vulnerable populations.
The national insurer changing a statute to make it easier for people whose behavior puts them at greater risk of contracting the virus to get annual screening.
CMS said it will now reimburse physicians for annual HIV screening for the following populations:
- Men who have had sex with men after 1975;
- Men and women having unprotected sex with multiple partners;
- Past or present injection drug users;