Hologic Archives - Page 9 of 9 - Medical Design Sourcing

AdvaMed unveils COVID-19 diagnostic supply registry

AdvaMed announced today that it created a comprehensive national COVID-19 diagnostic supply registry to aid state and federal pandemic responses.

According to a news release, AdvaMed is launching the registry in partnership with 13 commercial diagnostics manufacturers: Abbott (NYSE:ABT), Becton Dickinson (NYSE:BDX), bioMérieux, Bio-Rad Laboratories (NYSE:BIO), Beckman Coulter, Cepheid, Hologic (NSDQ:HOLX), Ortho Clinical Diagnostics, Qiagen (NYSE:QGEN), Roche Diagnostics, Sekisui Diagnostics, Siemens Healthineers (ETR: SHL), and Thermo Fisher Scientific (NYSE:TMO).

The AdvaMed registry is designed to compile information from the diagnostic companies, along with public data, to create a centralized and standardized COVID-19 diagnostic supply registry to update on weekly numbers at state and national levels regarding molecular, antigen and serology tests shipped in the U.S.

AdvaMed said in the release that the registry will also help streamline communicati…

Hologic launches first cart-based ultrasound system in U.S.

Hologic (NSDQ:HOLX) announced today that it launched its SuperSonic MACH 40 premium, cart-based ultrasound system in the U.S.

The Marlborough, Mass.-based company touts the SuperSonic platform as its first cart-based system, saying in a news release that the new system features strong image quality, standard-setting imaging modes and design to enhance efficiency and accuracy.

SuperSonic uses Hologic’s UltraFast imaging technology to provide frame rates of up to 20,000 images per second and enables new imaging modes while offering capabilities for future integrations and AI-driven innovations. It features ShearWave Plus technology to provide additional diagnostic information that may help with managing diagnostic workup of breast lesions, lesion targeting and lesion size measurement.

Clinicians using the SuperSonic MACH 40 system control it through Needle PL.U.S. imaging to visualize both the biopsy needle and anatomical structures in real-time.

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MedTech 100 roundup: Markets skid after strong stretch

Following a strong performance over the last couple of weeks, the medtech market experienced one of its most significant drop-offs in recent months amid investor worries over a rise in COVID-19 cases in some states.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 82.12 points at the end of last week (June 12). That total represents a -6% decrease from the 87.37-point total at the same time a week prior (June 5), highlighting a significant drop from one of the strongest stretches the medtech market had seen since the COVID-19 pandemic hit.

Meanwhile, the S&P 500 Index experienced a -4.8% decrease from June 5 to June 12, and the Dow Jones Index fared even worse with a -5.6% increase over the same period of time. The drop-off is stark compared to this time a week ago, when both indexes saw sizeable growth — rising 3.14% and 6.81%, respectively.

The earlier market surge came on the back of t…

Hologic says its Q3 financial outlook has improved

Hologic (NSDQ:HOLX) announced that the financial outlook for its current fiscal third quarter has improved since it reported its second-quarter results.

In April, Hologic reported profits of $94.8 million, or 36¢ per share, on sales of $756.1 million for the three months ended March 28, falling in line with Wall Street projections. In the company’s report, it said it expected the COVID-19 pandemic to have a significant negative impact on its future revenue and operating income.

Since then, Marlborough, Mass.-based Hologic’s breast and skeletal businesses have performed in line with expectations, while its surgical business has recovered more rapidly than forecast and its diagnostics business — benefitting from gaining FDA emergency nods for COVID-19 diagnostic tests and receiving U.S. funding for coronavirus test kits — has outperformed projections.

In a news release, the company said it now forecasts diagnostics revenue to grow by 20%-25% as…

FDA warns of cyanide gas danger with improper use of Hologic COVID-19 tests

Hologic’s Panther system (Image from Hologic)

The FDA warned laboratories today that using certain transport media for COVID-19 samples with Hologic (NSDQ:HOLX) Panther and Panther Fusion diagnostic systems can produce deadly cyanide gas.

Transport media is the liquid that maintains a specimen sample while it is transported to a laboratory. The Hologic Panther systems and others that have been sterilized using bleach can interact with transport media containing guanidine thiocyanate or similar chemicals to produce deadly cyanide gas, according to the agency. Guanidine thiocyanate may be referred to as guanidinium rhodanide, guanidinium thiocyanate or guanidinium.

While there have been reports of these potentially hazardous interactions, there have been no injuries reported to the FDA associated with exposure to cyanide gas as a result of using incompatible media with testing platforms.

Nu…

Hologic granted second molecular COVID-19 test EUA

Hologic (NSDQ:HOLX) announced today that it received FDA emergency use authorization (EUA) for its Aptima SARS-CoV-2 assay for detecting COVID-19.

Marlborough, Mass.-based Hologic’s Aptima test runs on its fully automated Panther system that provides initial results in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours.

Hologic said in a news release that it began distributing the new test and expects to produce an average of one million tests per week by combining its manufacturing capacity with what it touts as the world’s largest installed base of high-throughput molecular instruments.

Aspects of the Aptima assay project were conducted under a $13 million contract from the U.S. Dept. of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA).

Hologic intends to register the Aptima SARS-CoV-2 assay for CE Mark approval in Europe later this month, according …

What medtech’s top CEOs are saying about COVID-19

The COVID-19 pandemic is drying up sales for many large medical device companies, but there’s hope for a recovery later this year.

That’s the big message from medtech’s top CEOs as they issue financial predictions and engage in earnings calls with analysts.

Governments around the world are calling on medical device companies to make the supplies that health providers need to manage the virus: respirator masks, ventilators, infusion pumps, virus and antibody tests, and more.

At the same time, the same companies are taking a hit related to the devices and products used in elective procedures — and even procedures that people actually need — as hospitals focus on saving people with COVID-19.

It’s little wonder then that MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — remains down about 10% from its pre-pandemic Feb. 19 high point. (It’s still in better shape than the Dow Jones Industrial Averag…