Hologic Archives - Page 2 of 9 - Medical Design Sourcing

Hologic CEO MacMillan to chair Illumina’s board

Hologic CEO Stephen MacMillan

Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair.

Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer.

The move comes a week after activist investor Carl Icahn’s nominee — Andrew Teno — knocked out previous board chair John Thompson in a shareholder vote. CEO Francis deSouza survived another challenge from an Icahn-backed nominee.

“Both Steve and Scott collectively bring more than 30 years of experience in healthcare, and the appointments are part of our continual process to attract strong independent directors. We believe these two extremely talented business executives will help broaden the skills of the current Board, especially in the fields of corporate finance and international expans…

Hologic wins FDA clearance for COVID-flu-RSV assay

Tge Panther Fusion SARS-CoV-2/Flu A/B/RSV assay [Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV.

“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” Hologic Diagnostic Solutions President Jennifer Schneiders said in a news release.

“While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season, and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine…

Hologic turns to Eagles rookie Kelee Ringo and his mom to raise mammograms awareness

A screenshot from a video announcing a partnership between Hologic and NFL player Kelee Ringo. From left, Dr. DaCarla Albright, Tralee Hale, Kelee Ringo. [Image from Hologic]Hologic (Nasdaq:HOLX) today announced a new partnership with recently drafted NFL quarterback Kelee Ringo and his mother.

The partnership with Ringo and his mother, breast cancer survivor Tralee Hale, aims to provide education around breast health. That includes the importance of prioritizing annual mammograms and other key health screenings.

Last month, the Philadelphia Eagles drafted Ringo, a two-time national champion out of the University of Georgia. Ringo, Hale and Hologic timed the launch of their partnership around Mother’s Day and National Women’s Health Week this week.

According to a news release, Hale spent time focused on managing her family, career and other commitments, failing to prioritize preventive care screenings. As a single mother, she received a breast c…

Hologic beats The Street in Q2, raises guidance

Hologic (Nasdaq:HOLX) + today posted second-quarter results that topped the consensus forecast despite dipping COVID-19-related sales.

The Marlborough, Massachusetts-based women’s health and diagnostics company posted profits of $218.5 million. That amounts to 87¢ per share on sales of $1.03 billion for the three months ended April 1, 2023.

Hologic posted a 52% bottom-line slide on a sales decline of 28.5%. Significantly lower sales of COVID-19 assays — as expected — drove the declines. However, revenue still topped the company’s guidance range of $930 million to $980 million. Plus, excluding COVID-19-related revenues, total organic revenue grew by 20.2%.

Adjusted to exclude one-time items, earnings per share came in at $1.06. That landed 18¢ ahead of projections on Wall Street. Sales posted a beat, too, as analysts expected $958.8 in revenues.

Excluding COVID-19 sales, diagnostic revenues ticked up…

FDA approves BD HPV assay for use with Hologic ThinPrep Pap test

The Onclarity HPV assay. [Image courtesy of BD]BD (NYSE:BDX) announced today that it received FDA approval for its Onclarity HPV assay for use with the ThinPrep Pap test.

The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in the U.S.

BD said in a news release that including ThinPrep in its testing offerings improves access to the benefits of its human papillomavirus virus (HPV) assay. That assay has approval for an extended set of HPV types. This includes HPV31, which poses a high risk for causing cervical cancer. In total, it detects and identifies 14 high-risk HPV types in a single analysis.

“Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer,” said Brooke Story, worldwide president of integrated diagnostics solutions for BD. &#…

Hologic NovaSure V5 endometrial ablation device wins European, Canadian approval

The NovaSure V5 endometrial ablation device. [Image courtesy of Hologic]Hologic (Nasdaq:HOLX) announced today that Canadian and European officials approved its NovaSure V5 global endometrial ablation (GEA) device.

Marlborough, Massachusetts-based Hologic designed the device to treat a wide range of cervical and uterine anatomies. It offers treatment for abnormal uterine bleeding.

In a news release, Hologic cites 97% patient satisfaction with NovaSure. The device also demonstrated 87% avoidance of a hysterectomy at 10 years.

“Since its launch over 20 years ago, we have constantly listened to our customers’ feedback, which has driven continuous design improvements for NovaSure,” said Jan Verstreken, Hologic group president, international. “This has enabled us to develop our technology to further meet their needs and those of the women they treat, ultimately delivering better outcomes for these women.”

NovaSure V5 features an updated cervical seal with …

5 reasons you should feel good about medtech companies in 2023

[Image from Pixabay]“Macroeconomic headwinds” is a phrase repeated a lot these days, but a string of positive medtech company earnings reports this week should cheer medical device industry insiders.

The medical device industry may once again prove that it’s an economically resilient space.

“While 2022 brought its share of supply chain and inflationary pressures, directionally, many companies note easing within the supply chain, lessening inflationary impacts, healthy capital demand, and improving procedural recovery. We think as these dynamics take shape through 2023, MedTech’s outlook and subsequent sector performance in the market will improve,” BTIG analyst Ryan Zimmerman told MassDevice via email.

Investors are finally looking past a lot of the macro challenges, according to Mike Matson, a senior research analyst at Needham & Co.

“While the medtech industry isn’t out of the woods yet, things have started t…

Hologic starts the year strongly

Hologic (Nasdaq: HOLX) reported Street-beating first-quarter results, with company officials confident enough to boost full-year revenue and earnings guidance.

Revenue from the women’s health and diagnostics company’s COVID-19 assays may be in decline. Plus, there are supply chain challenges related to semiconductor chips in its Breast Health business. Despite the hurdles, sales growth is strong for Hologic’s non-COVID business, the company reported yesterday evening.

It was the latest in a string of positive earnings reports this week from medical device companies, including Stryker, BD and Edwards Lifesciences. (Boston Scientific was mostly positive, too.)

Marlborough, Massachusetts–based Hologic earned $187.4 million, or 75¢ per share, off $1.074 billion for the quarter ended Dec. 31, 2022. The results represented a 62% bottom-line decline and a 27% decrease in revenue compared with the same quarter a year ago.

Adjusted to exc…

Fresenius Medical Care joins health equity pledge

Fresenius Medical Care announced today that it joined the Zero Health Gaps Pledge at the World Economic Forum in Davos, Switzerland.

As part of the Global Health Equity Network (GHEN), the pledge brings together stakeholders from the public and private sectors. In line with the UN Sustainable Development Goals, they aim to advance a collective vision of “Zero Health Gaps,” making improvements in health equity.

In total, 39 organizations joined the pledge. Medtronic announced yesterday that it took part. Other medtech companies joining include Henry Schein, Hologic and Philips, according to the World Economic Forum.

Fresenius said its involvement marks a commitment to “meaningful action and collaboration toward health equity.”

“We believe that access to equitable and high-quality health care is a fundamental human right, and we are committed to working with global leaders and organizations to improve the lives of millions of…

Hologic expects Q1 revenues, EPS to top prior guidance

Hologic (Nasdaq:HOLX) today announced preliminary first-quarter revenue results for the three months ended Dec. 31, 2022.

Marlborough, Massachusetts-based Hologic expects to report revenues of approximately $1.07 billion. That represents a 27% decrease from the same period of the previous year. However, it comes in above Hologic’s guidance range of $940 million to $990 million set in October.

These revenues would also top expectations on Wall Street as analysts projected sales totaling $966.4 million.

Hologic’s diagnostics business saw the biggest drop year-over-year with a 41.2% decrease in sales.

“We delivered robust revenue performance in our fiscal first quarter of 2023, with our Diagnostics and Surgical businesses growing organically double-digits in constant currency, excluding COVID,” said Steve MacMillan, Hologic chair, president and CEO. “In addition, recovery in our breast health business is underway, with results ahead of ou…

How this medtech molder is navigating challenging times

Mark Gomulka is the CEO of Westfall Technik. [Photo courtesy of Westfall Technik]

5 questions with Westfall Technik CEO Mark Gomulka

Mark Gomulka has had a busy first year as CEO of plastics contract manufacturer Westfall Technik.

Gomulka joined Las Vegas–based Westfall Technik in September 2021 after five years at Flex and 15 years at Nypro before that.

Formed in 2017 with 20 acquisitions closed and more on the way, the end-to-end plastics manufacturer’s revenue is now around $400 million per year with approximately 20% year-over-year sales growth, Gomulka said.

“I’m having fun doing this, because I think we’re creating something,” Gomulka said in an interview. “We have 2,500 employees. That means we serve 2,500 families. And most importantly, we have incredible customers that took a gamble on us and continue to take a gamble on a company that five years ag…

Hologic stock rises on Street-beating Q4 despite continued supply chain challenges

Hologic (Nasdaq:HOLX) shares are up today — a day after fourth-quarter results that came in well ahead of the consensus forecast.

Shares of HOLX were up more than 8% at $73.80 apiece by afternoon trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 2%.

The Marlborough, Massachusetts-based company yesterday evening posted profits of $118.7 million for the quarter. That amounts to 47¢ per share on sales of $953.3 million for the three months ended Sept. 24, 2022.

Year-over-year, Hologic reported a 63.9% bottom-line slide on a sales decline of 27.6%. Diagnostics sales dipped by 37.8% but, excluding COVID-19-related products, grew by 7.8%. Breast health sales declined 17.7%.

The company attributed its dips to lower COVID-19 assay sales and supply chain challenges. The company dealt with supply chain issues related to semiconductor chips in its breast health business. How…