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HIV/AIDs

Hologic gains FDA nod for HIV test

November 24, 2020 By Sean Whooley

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, […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: FDA, HIV/AIDs, Hologic

8 women medtech innovators you need to know

March 15, 2018 By Danielle Kirsh

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 […]

Filed Under: Blood Management, Cardiovascular, Diabetes, Diagnostics, Healthcare Reform, Hospital Care, Imaging, Regenerative Medicine Tagged With: American Red Cross, cardiology, chemotherapy, HIV/AIDs, leprosy, leukemia, malaria, MedTech, radiography, vision impairment, X-ray

Feds: Energex founder embezzled $230k for gambling debts, personal expenses

May 28, 2013 By Sony Salzman

EnergexCEOIndictment

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.

Filed Under: Legal News, News Well Tagged With: Energex Systems, HIV/AIDs

HIV prevention: Could fatty particles protect women worldwide from AIDS?

September 27, 2011 By MassDevice Leave a Comment

Liposome

These hollow particles seemed
to work with minimal tweaking.

By Nancy Fliesler

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.

Filed Under: News Well, Women's Health Tagged With: HIV/AIDs

Credit card sized field blood lab detects HIV and other diseases in minutes

August 3, 2011 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Diagnostics, Medicare, News Well, Pharmaceutical Tagged With: Claro Diagnostics Inc., HIV/AIDs

Medtronic’s sales may slide on allegations of Infuse cover-up

June 29, 2011 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Blood Management, Food & Drug Administration (FDA), Legal News, Medicare, News Well Tagged With: HIV/AIDs

Study: Medtronic’s aortic valve replacement system improves quality of life | Research roundup

May 18, 2011 By MassDevice staff Leave a Comment

M and A Roundup

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.

Filed Under: News Well, Orthopedics Tagged With: Avedro Inc., Baeta Corp., Boston Scientific, Clinical Trials, HIV/AIDs

PointCare raises $1.8 million

September 28, 2010 By MassDevice staff Leave a Comment

PointCare logo

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.

Filed Under: Business/Financial News, Diagnostics, News Well Tagged With: HIV/AIDs, Pointcare Technologies

CMS shifts coverage on HIV screening

December 8, 2009 By MassDevice staff Leave a Comment

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;

Filed Under: Diagnostics, News Well Tagged With: Centers for Medicare and Medicaid Services (CMS), HIV/AIDs

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