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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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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29 cutting-edge medtech innovations recognized with Edison Awards

More than two dozen medical technology developers are winners of the 2023 Edison Awards.

The 29 medtech winners include products from Boston Scientific, Shockwave Medical, Thermo Fisher, DermaSensor and Endiatx. They span four categories: engineering and robotics; health, medical and biotech; manufacturing and logistics; and personal technology and gadgets. Subcategories include smart wearables, noninvasive medtech, advanced drug delivery, AI-assisted medicine, operating room integration and more.

The winners are all finalists for gold, silver and bronze awards. Those awards will be revealed at the Edison Awards Gala on April 20, 2023, in Fort Myers, Florida.

Endiatx co-founder and CEO Torrey Smith with PillBot [Photo by Hardy Wilson for MDO]

Special honors went to Endiatx, which stands by itself as a “game changer” among the approximately 150 Edison Awards winners. Medical Design &…
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Report: EU may hit Illumina with maximum penalty over Grail deal

Reuters reported this week that Illumina (Nasdaq:ILMN) may face a heavy penalty in Europe for completing its acquisition of Grail.

According to the report, the likelihood is that Illumina is penalized with a fine totaling 10% of its global annual turnover — the maximum penalty available. This comes as a result of the company closing the acquisition of Grail without European Union antitrust approval. Reuters cited “people familiar with the matter” in its report.

Reuters also said Illumina prepared $453 million to pay a potential EU fine with a plan to appeal against a penalty. The company believes its merger with Grail remains “pro-competitive” and in the best interests of patients worldwide, the report said.

The report stated that Illumina challenged the EU veto on the deal.

The history behind Illumina’s attempt to acquire Grail

The much-scrutinized acquisition of Grail, a cancer detection te…

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European Commission blocks Illumina’s Grail acquisition, company to appeal

Illumina (Nasdaq:ILMN) announced today that the European Commission issued a decision prohibiting its planned acquisition of Grail.

San Diego-based Illumina said it is reviewing the order and intends to appeal the decision. The new hurdle in Europe follows last week’s U.S. Federal Trade Commission ruling in favor of the acquisition moving forward. An administrative law judge in the U.S. rejected the FTC’s argument that the $8 billion acquisition of Grail is anti-competitive.

The much-scrutinized acquisition of Grail, a cancer detection technology developer, has met a series of roadblocks along the way. In September 2020, Illumina agreed to acquire Grail, a startup that initially spun out from the company in 2016.

Illumina completed the acquisition in August 2021. However, Illumina agreed to hold Grail as a separate company as the European Commission conducted a regulatory review. Illumina argued Grail has no business in Europe. The company said the…

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Illumina clears antitrust hurdle related to merger with Grail

Illumina (Nasdaq:ILMN) announced today that an administrative law judge in the U.S. has rejected the Federal Trade Commission’s argument that the company’s $8 billion acquisition of Grail was anti-competitive.

More than a year after the deal closed, Illumina is still keeping Grail operating as a separate internal entity under a European Commission order. The EU investigation continues, with the company setting aside $609 million in legal contingencies during its second quarter in anticipation of a potential fine.

For now, Illumina has scored a legal win in the U.S. The FTC, like its European counterparts, had argued that the merger could hurt competition and innovation around multi-cancer early detection tests.

“Reuniting Illumina and Grail will transform the detection and treatment of cancer by facilitating widespread, affordable access to Grail’s life-saving Galleri test. This decision is a step toward making that vision a reali…

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Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies

[Image via Blogtrepreneur on Flickr, per Creative Commons 2.0 license]

Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s.

The research firm’s previous quarterly report in February called attention to continued supply chain and labor problems for medtech.

Below are the key highlights for medical device companies from the latest report.

Medical device cybersecurity

The report flagged legislative proposals for new rules and regulations on medical device developers and manufacturers, including new cybsecurity rules.

“The industry is ripe for increased oversight of cyber risks,” the analysts wrote in their report. “We have identified the sector as having a medium high exposure to cyber risk. And our survey of rated healthcare issuers indicates that medical de…

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Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

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Medtech M&A: The industry’s biggest mergers and acquisitions of 2021

[Image from Jp Valery on Unsplash]

Across 2021, medtech has seen a wide range of mergers and acquisitions covering several areas of devices, pharmaceuticals and more.

Some have gone off without a hitch, while others fell into serious scrutiny as mouthwatering financial figures were revealed and major technologies were acquired.

Here are the 10 biggest mergers and acquisitions in medtech in 2021:

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