The top IVD and diabetes tech stories of 2023

The G7 CGM helps users manage their diabetes. [Image courtesy of Dexcom]Over the course of 2023, the medtech industry produced another impressive year of innovation, with news coming from a variety of spaces.

Chiefly among those were diabetes technologies and in vitro diagnostics (IVDs). We saw regulatory nods, product launches, funds raised and mergers fall apart.

Looking at those two spaces in particular, here are five diabetes and IVD stories that caught our attention in 2023:

5. Cytovale raises $84M Series C for sepsis diagnostic

In November, Cytovale announced that it raised $84 million in a Series C funding round to support its rapid sepsis diagnosis test. Cytovale earmarked funds to support the wider expansion of this testing technology.

The FDA cleared the IntelliSep test, which aids hospital emergency departments and health systems, in January. IntelliSep provides test results in under 10 minutes, offering actionable answers using standard b…

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Illumina will divest Grail after court backs FTC ruling

Illumina (Nasdaq:ILMN) announced on Sunday that it plans to divest Grail after a drawn-out legal battle over the $7.1 billion acquisition.

In September 2020, Illumina announced an agreement to acquire Grail, a DNA sequencing and array-based tech developer. Grail itself was a startup that initially spun out from the company in 2016.

Illumina completed the acquisition in August 2021 but faced never-ending scrutiny in the two years that followed.

All events built up to a Dec. 15 decision from the U.S. Fifth Circuit Court of Appeals, upholding an order from the U.S. Federal Trade Commission (FTC) to unwind the acquisition.

In a Dec. 17 press release, Illumina said it has no intention to pursue further appeals of this decision. It previously stated that, if unsuccessful in its U.S. or European efforts to appeal decisions to unwind, it would agree to divest Grail. The European Commission ordered Illumina to divest Grail in October.

Illumina said …

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EU orders Illumina to divest Grail after ‘unlawful’ merger

The European Commission today announced it has ordered Illumina (Nasdaq: ILMN) — the DNA sequencing and array-based tech developer — to unwind and divest its Grail acquisition.

The decision follows the commission’s decision to prohibit the transaction in September 2022 over concerns the merger would be anticompetitive and “stifle” innovation in the market.

Despite the disapproval of the EU Commission, Illumina and Grail “unlawfully completed the merger during the commission’s in-depth investigation,” the EU said in a news release. The move was against EU merger control rules, and the commission issued significant fines to Illumina and Grail in July as a result of the proposed merger.

“Today’s decision restores competition in the development of early cancer detection tests. These tests could represent a breakthrough in our fight against cancer. By ordering Illumina to restore Grail’s independence, we ensure a leve…

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Illumina picks a new CEO amid SEC investigation

Jacob Thaysen, Illumina’s incoming CEO [Image courtesy of Illumina]Illumina (Nasdaq: ILMN) — the DNA sequencing and array-based tech developer — has tapped an Agilent Technologies executive as its new CEO as it seeks to move beyond regulatory scrutiny of its acquisition of Grail.

Jacob Thaysen, an Agilent Technologies SVP and president of its Life Sciences and Applied Markets Group, takes over Illumina’s corner office on Sept. 25.  Charles Dadswell, Illumina’s interim CEO, will resume his position as SVP and general counsel once Thaysen becomes CEO.

“After conducting a robust search process, we are thrilled to have found someone of Jacob’s caliber to become chief executive of Illumina and help shape and lead the company into its next phase of growth,” said Hologic CEO Stephen P. MacMillan, who is chair of Illumina’s board.

Illumina described Thaysen as having a long history in clinical – specifically oncology – diag…

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Illumina says SEC is investigating Grail acquisition

Add a U.S. Securities and Exchange Commission investigation to the list of problems that Illumina has faced since it acquired Grail for $8 billion in 2021.

Illumina disclosed the investigation in its 10-Q filed with the SEC on Aug. 10: “In July 2023, we were informed that the staff of the SEC was conducting an investigation relating to Illumina and was requesting documents and communications primarily related to Illumina’s acquisition of Grail and certain statements and disclosures concerning Grail, its products and its acquisition, and related to the conduct and compensation of certain members of Illumina and Grail management, among other things. Illumina is cooperating with the SEC in this investigation.”

The news comes about a month after the European Commission fined the company approximately $478.9 million (€432 million) for completing the merger in August 2021 before the Commission had weighed in on whether the deal was anti-competitive. Withi…

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EU hits Illumina with $478M fine over Grail deal

The European Commission announced today that it issued significant fines to Illumina (Nasdaq:ILMN) and Grail as a result of their proposed merger.

European authorities fined Illumina approximately $478.9 million (€432 million) and Grail $1,108 (€1,000). They claim the companies implemented their proposed merger before approval by the Commission. Such actions breach European Union merger control rules.

The rules require merging companies to wait until the Commission approves the deal before implementing it. European officials opened an investigation into Illumina’s acquisition of Grail in 2021 before blocking the transaction in 2022. They reasoned that the deal may have significant anticompetitive effects in the blood-based early cancer detection market.

In August 2021, amid the Commission’s review, Illumina publicly announced the completion of the $7.1 billion acquisition. The companies executed all necessary documents and Grail merged with t…

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Illumina’s record EU fine could drive smaller M&A pharma deals

This table summarizes some of the largest fines from the European Union on companies for a variety of violations.

Illumina, the world’s largest gene sequencing company, faces a record fine from the E.U. for acquiring startup Grail without approval. The $8 billion deal closed in August 2021 despite ongoing EU. and U.S. investigations. A year later, the EU prohibited the merger, citing reduced innovation and choice. The expected $453 million fine, which would be the largest ever in the E.U. that aims to deter unauthorized deals. The chart on the right shows some of the most substantial fines in EU history.

Francis deSouza resigned as CEO and director of Illumina Inc. on June 11, 2023. The company named Charles Dadswell, senior vice president and general counsel, as interim CEO, while the board conducts a search for a new CEO.

Grail’s pioneering work on early cancer detection through blood tests pu…

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CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

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Illumina’s CEO resigns, MacMillan expresses confidence

Illumina Inc. (NASDAQ: ILMN) announced that CEO Francis deSouza has resigned from the DNA sequencing and array-based tech developer.

The news, announced yesterday, comes more than a week after Hologic CEO Stephen MacMillan became non-executive board chair. Edwards Lifesciences CFO Scott Ullem filled a second new seat, bringing the board seat total to 12.

Illumina experienced some board changes after activist investor Carl Icahn’s candidate knocked the previous board chair John Thompson out of his position, though deSouza was able to survive his own Icahn-supported challenge.

“We thank Francis for his contributions and leadership, and are very excited about embarking on the next chapter of Illumina’s great journey,” MacMillan said in a news release. “Illumina’s technology remains at the forefront of DNA sequencing and has continued to set the pace for the industry. We are confident Illumina can continue to execute on it…

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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…

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Illumina launches cloud-based next-gen sequencing software

[Image courtesy of Illumina]Illumina (Nasdaq:ILMN) announced today that it released its Connected Insights cloud-based software for next-generation sequencing (NGS).

San Diego-based Illumina designed Connected Insights to streamline interpretation and reporting from a range of assay types. This enables labs to scale the use of NGS. They can also reduce turnaround times for clinical reporting by integrating third-party knowledge bases.

Illumina said its initial release supports oncology applications. It coincides with the increasing use of comprehensive genomic profiling (CGP) for advanced tumors. The company aims to ultimately support a diverse range of applications, including whole-genome sequencing (WGS) for rare diseases.

While Connected Insights undergoes beta testing in the U.S., Illumina said it offers it commercially in a limited number of countries.

“We’re seeing growing demand for NGS testing in health care systems, and with that…

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Layoffs in medtech: These companies recently reduced their workforce

[Image courtesy of Nastuh Abootalebi on Unsplash] The workforce reduction trend has swept the economy recently, and unfortunately, the medtech space is not immune to layoffs.

You’ve probably read about the ongoing layoffs sweeping the tech industry, media and more.

For instance, Yahoo, Disney, Zoom and more all reported workforce reductions as companies across industries grapple with economic pressures. Think inflation, supply chain challenges and more.

Medtech has shown some resilience in the present environment. Some major medical device companies released positive earnings.  However, others announced headcount reductions, citing macroeconomic headwinds. Others felt the weight of regulatory issues and restructuring efforts.

Here are a few companies across medtech that enacted layoffs over the past several months.


In 3M’s fourth-quarter earnings report, the company announced that it plans to reduce its global manufacturing workforc…

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